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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04124120
Registration number
NCT04124120
Ethics application status
Date submitted
10/10/2019
Date registered
11/10/2019
Titles & IDs
Public title
Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
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Scientific title
Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial
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Secondary ID [1]
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1703018094-ROMA-Women
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Universal Trial Number (UTN)
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Trial acronym
ROMA:Women
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Diseases
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Coronary Artery Disease
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Coronary Artery Bypass Grafting
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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0
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Single arterial graft
Treatment: Surgery - Multiple arterial grafting
Experimental: Single Arterial Graft (SAG) group - Patients in this group will receive a single arterial graft which will be the left internal thoracic artery. Additional grafts used in this group will all be venous grafts.
Experimental: Multiple Arterial Graft (MAG) group - Patients in the group will receive multiple arterial grafts. All patients will receive at least two arterial grafts, the left internal thoracic artery with the addition of either the right internal thoracic artery or the radial artery as the second conduit. Some patients may receive additional arterial grafts consisting of the radial artery, the right internal thoracic artery, or the right gastroepiploic artery.
Treatment: Surgery: Single arterial graft
This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.
Treatment: Surgery: Multiple arterial grafting
This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary outcome for aim 1: Death from any cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
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Assessment method [1]
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The primary outcome for aim 1 will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (\>48 hours after surgery), repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
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Timepoint [1]
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Postoperatively, minimum 2.5 year follow-up
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Primary outcome [2]
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Primary outcome for aim 2: Disease-specific quality of life
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Assessment method [2]
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Assessed using the Seattle Angina Questionnaire (SAQ), a validated 19-item questionnaire that measures five domains related to coronary disease: angina frequency, physical limitations, quality of life, angina stability, and treatment satisfaction. Scores range from 0 to 100 with higher scores indicating fewer symptoms and better health status. The minimum clinically important difference on the SAQ is 5 points.
The primary endpoint for aim 2 is the absolute change in the Seattle Angina Questionnaire (SAQ) at 12 months compared to baseline.
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Timepoint [2]
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Postoperatively, minimum 2.5 year follow-up
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Secondary outcome [1]
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Death from any cause, any stroke, non-procedural myocardial infarction, and repeat revascularization.
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Assessment method [1]
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One of the secondary outcomes for aim 1: It will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (\>48 hours after surgery), and repeat revascularization.
This is the primary outcome of the parent ROMA trial.
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Timepoint [1]
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Postoperatively, minimum 2.5 year follow-up
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Secondary outcome [2]
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Death from cardiac cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
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Assessment method [2]
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Another secondary outcome for aim 1: It will be a composite of the first occurrence of death from cardiac cause, any stroke, non-procedural myocardial infarction (\>48 hours after surgery), repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure.
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Timepoint [2]
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Postoperatively, minimum 2.5 year follow-up
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Secondary outcome [3]
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Death from any cause
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Assessment method [3]
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Another secondary outcome for aim 1: Death will be considered to be cardiac unless a definite non-cardiac cause is identified.
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Timepoint [3]
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Postoperatively, minimum 2.5 year follow-up
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Secondary outcome [4]
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Stroke
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Assessment method [4]
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Another secondary outcome for aim 1: Based on the American Heart Association/American Stroke Association Expert Consensus stroke definition, stroke will be identified in case of:
1. pathological, imaging, or other objective evidence of cerebral ischemic injury in a defined vascular distribution; OR
2. clinical evidence of cerebral ischemic injury based on symptoms persisting =24 hours or until death, and other etiologies excluded.
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Timepoint [4]
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Postoperatively, minimum 2.5 year follow-up
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Secondary outcome [5]
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Non-procedural myocardial infarction
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Assessment method [5]
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Another secondary outcome for aim 1: Based on the 4th Universal Definition, non-periprocedural myocardial infarction will be identified in case of detection of rise and/or fall of cardiac biomarkers with at least one value above the 99th percentile of the upper reference limit together with evidence of myocardial ischemia with at least one of the following:
1. symptoms of ischemia
2. electrocardiogram changes indicative of new ischemia (new ST-T changes or new left bundle branch block)
3. development of pathological Q waves in the electrocardiogram
4. imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
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Timepoint [5]
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> 48 hours postoperatively, minimum 2.5 year follow-up
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Secondary outcome [6]
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Repeat revascularization
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Assessment method [6]
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Another secondary outcome for aim 1: Repeat revascularization will include any percutaneous or surgical revascularization on a grafted coronary artery after the initial operation.
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Timepoint [6]
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Postoperatively, minimum 2.5 year follow-up
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Secondary outcome [7]
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Readmission for acute coronary syndrome
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Assessment method [7]
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Another secondary outcome for aim 1: Prolonged ischemic symptoms at rest (usually =10 minutes in duration), or accelerating pattern of chest pain that occurs with a lower activity threshold (CCS class III or IV) considered to be myocardial ischemia upon final diagnosis resulting in an unscheduled visit to a healthcare facility resulting in an overnight stay generally within 24 hours of the most recent symptoms, cardiac biomarkers not meeting MI criteria, and ECG or angiographic evidence of ischemia.
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Timepoint [7]
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Postoperatively, minimum 2.5 year follow-up
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Secondary outcome [8]
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Readmission for heart failure
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Assessment method [8]
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Another secondary outcome for aim 1: While patients may have multiple simultaneous disease processes, for the outcome event of heart failure requiring hospitalization, the diagnosis of congestive heart failure would need to be the primary process. Heart failure (HF) requiring hospitalization is defined as an event that meets the following criteria:
i. Requires hospitalization AND ii. Clinical symptoms of heart failure AND iii. Physical signs of heart failure AND iv. Need for additional/increased therapy AND v. No other non-cardiac etiology (such as chronic obstructive pulmonary disease, hepatic cirrhosis, acute renal failure, or venous insufficiency) and no other cardiac etiology (such as pulmonary embolus, cor pulmonale, primary pulmonary hypertension, or congenital heart disease) for signs or symptoms are identified.
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Timepoint [8]
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Postoperatively, minimum 2.5 year follow-up
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Secondary outcome [9]
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Generic quality of life according to the Short Form Health Survey (SF-12v2)
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Assessment method [9]
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Secondary outcomes for aim 2: The SF-12v12 measures eight dimensions of health: physical functioning, role limitations due to physical problems, bodily pain, vitality, general health perception, social function, role limitations due to emotional problems, and mental health. Scores for each domain range from 0 to 100 with higher scores indicating better health status.
The SF-12v2 has two summary measures: physical and mental self-perceived health with norm-based methods that standardize the score to a mean of 50 and standard deviation of 10.
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Timepoint [9]
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Postoperatively, minimum 2.5 year follow-up
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Secondary outcome [10]
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Generic quality of life according to EuroQuol-5D (EQ-5D)
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Assessment method [10]
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Secondary outcomes for aim 2: EQ-5D is a five-item instrument to assess health status in the following five dimensions: mobility, self-care, usual activity, pain or discomfort, and anxiety or depression. Individual domain scores will be converted to a summary index representing utility weights, which allow conduct of cost-effectiveness analyses.
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Timepoint [10]
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Postoperatively, minimum 2.5 year follow-up
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Secondary outcome [11]
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Mental and physical health symptoms according to PROMIS instruments
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Assessment method [11]
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Secondary outcomes for aim 2: Physical and mental health symptoms and physical functioning will be measured with standardized PROMIS instruments, including: Pain interference, Neuropathic Pain, Fatigue, Sleep disturbance, Depression, Anxiety, and Physical Function. A mean of 50 and a standard deviation of 10 represent the general population in the US.
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Timepoint [11]
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Postoperatively, minimum 2.5 year follow-up
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Eligibility
Key inclusion criteria
1. Women patients =18 years old.
2. Isolated coronary artery bypass grafting.
3. Primary (first time) cardiac surgery procedure.
4. Significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Male gender
* Single graft
* Emergency operation
* Myocardial infarction within 72 hours of surgery
* Left ventricular ejection fraction < 35%
* Any concomitant cardiac or non-cardiac procedure
* Previous cardiac surgery
* Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduces life expectancy to less than 5 years.
* Inability to use the saphenous vein or to use both radial and right internal thoracic arteries
* Anticipated need for coronary thrombo-endarterectomy
* Planned hybrid revascularization
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2030
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Actual
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Sample size
Target
2000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The University of Melbourne - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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Connecticut
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Georgia
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Illinois
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Maryland
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Massachusetts
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Nebraska
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Utah
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Austria
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Graz
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Austria
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Innsbruck
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Linz
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Vienna
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Ontario
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Montréal
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New Westminster
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Beijing
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Jilin
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Zagreb
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Hradec Králové
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Czechia
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Nové Mesto
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Denmark
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Aalborg
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Copenhagen
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Germany
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Bad Oeynhausen
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Germany
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Berlin
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Essen
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Frankfurt
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Gießen
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Göttingen
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Jena
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Leipzig
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Stuttgart
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Germany
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Trier
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India
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Tamil Nadu
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India
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Telangana
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Israel
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Haifa
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Italy
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Bari
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Italy
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Italy
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Brescia
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Italy
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Cotignola
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Italy
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Florence
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Italy
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Roma
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Italy
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Torino
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Tokyo
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Japan
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Saitama
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Korea, Republic of
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Seoul
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Seúl
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Netherlands
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Maastricht
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North Macedonia
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Skopje
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Poland
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Katowice
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Zabrze
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Russian Federation
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Tomsk
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Serbia
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Belgrade
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Singapore
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Singapore
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Pamplona
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Sweden
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Gothenburg
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Taiwan
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Taipei
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United Kingdom
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Oxford
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United Kingdom
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Clydebank
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Edinburgh
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United Kingdom
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Hull
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United Kingdom
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Leicester
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Middlesbrough
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United Kingdom
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Sheffield
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0
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Other
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Name
Weill Medical College of Cornell University
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Address
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Other collaborator category [1]
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0
Other
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Name [1]
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New York Presbyterian Hospital
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0
0
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0
0
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Other collaborator category [2]
0
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Other
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Name [2]
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Sunnybrook Health Sciences Centre
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0
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0
0
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Other collaborator category [3]
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Other
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Name [3]
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Cedars-Sinai Medical Center
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Other
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Columbia University
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Duke University
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Summary
Brief summary
The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grfating (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grfating (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,000 women randomized 1:1 to MAG or SAG (690 from the parent ROMA trial + 1,310 from ROMA:Women). Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.
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Trial website
https://clinicaltrials.gov/study/NCT04124120
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Trial related presentations / publications
Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW, Golding LA, Gill CC, Taylor PC, Sheldon WC, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med. 1986 Jan 2;314(1):1-6. doi: 10.1056/NEJM198601023140101. Tatoulis J, Buxton BF, Fuller JA. Patencies of 2127 arterial to coronary conduits over 15 years. Ann Thorac Surg. 2004 Jan;77(1):93-101. doi: 10.1016/s0003-4975(03)01331-6. Lytle BW, Blackstone EH, Loop FD, Houghtaling PL, Arnold JH, Akhrass R, McCarthy PM, Cosgrove DM. Two internal thoracic artery grafts are better than one. J Thorac Cardiovasc Surg. 1999 May;117(5):855-72. doi: 10.1016/S0022-5223(99)70365-X. Taggart DP, D'Amico R, Altman DG. Effect of arterial revascularisation on survival: a systematic review of studies comparing bilateral and single internal mammary arteries. Lancet. 2001 Sep 15;358(9285):870-5. doi: 10.1016/S0140-6736(01)06069-X. Yi G, Shine B, Rehman SM, Altman DG, Taggart DP. Effect of bilateral internal mammary artery grafts on long-term survival: a meta-analysis approach. Circulation. 2014 Aug 12;130(7):539-45. doi: 10.1161/CIRCULATIONAHA.113.004255. Epub 2014 Jun 10. Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Cardiovascular Anesthesiologists; Society of Thoracic Surgeons. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 Dec 6;58(24):e123-210. doi: 10.1016/j.jacc.2011.08.009. Epub 2011 Nov 7. No abstract available. Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available. Aldea GS, Bakaeen FG, Pal J, Fremes S, Head SJ, Sabik J, Rosengart T, Kappetein AP, Thourani VH, Firestone S, Mitchell JD; Society of Thoracic Surgeons. The Society of Thoracic Surgeons Clinical Practice Guidelines on Arterial Conduits for Coronary Artery Bypass Grafting. Ann Thorac Surg. 2016 Feb;101(2):801-9. doi: 10.1016/j.athoracsur.2015.09.100. Epub 2015 Dec 8. Benedetto U, Raja SG, Albanese A, Amrani M, Biondi-Zoccai G, Frati G. Searching for the second best graft for coronary artery bypass surgery: a network meta-analysis of randomized controlled trialsdagger. Eur J Cardiothorac Surg. 2015 Jan;47(1):59-65; discussion 65. doi: 10.1093/ejcts/ezu111. Epub 2014 Mar 30.
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Public notes
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Contacts
Principal investigator
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Mario Gaudino, Prof/PhD/MD
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Weill Medical College of Cornell University
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Mario Gaudino, Prof/PhD/MD
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212.746.1812
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Primary outcome data under request
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
From publication until the third year after publication
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Available to whom?
Research scope
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04124120