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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12618000149268
Ethics application status
Approved
Date submitted
21/01/2018
Date registered
31/01/2018
Date last updated
28/03/2022
Date data sharing statement initially provided
1/10/2019
Date results information initially provided
28/03/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Coronary and Peripheral Haemodynamic Studies of Angina with No Obstructive Coronary Artery Disease.
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Scientific title
Clinical and coronary haemodynamic determinants of recurrent chest pain in patients with no obstructive coronary artery disease.
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Secondary ID [1]
293492
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Nil Known
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Universal Trial Number (UTN)
U1111-1206-8080
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Trial acronym
NoCAD1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Angina
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Condition category
Condition code
Cardiovascular
305133
305133
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0
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Coronary heart disease
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Cardiovascular
305460
305460
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Patients with angina and no obstructive coronary artery disease on invasive diagnostic coronary angiography will undergo comprehensive invasive coronary haemodynamic studies at the time of procedure to evaluate possible coronary vasomotor disorder leading to patient's symptoms and then relating the testing results to outcome, which in this study is ongoing chest pain at 1, 6 and 12 months follow up.
Haemodynamic studies will include the assessment of resting angiographic contrast flow, coronary microvascular hyperaemic function, coronary endothelial function and provocative coronary spasm testing. This comprehensive testing will add 30-45 minutes to the diagnostic coronary angiography procedure.
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Intervention code [1]
299914
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Diagnosis / Prognosis
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Recurrent angina which is defined as one or more episodes of pain per week determined from the Seattle Angina Questionnaire.
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Assessment method [1]
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Timepoint [1]
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1, 6 and 12 months (primary timepoint) after coronary haemodynamics study,
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Secondary outcome [1]
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Hospital admission with recurrent angina.
The information will be obtained from linkage to medical records.
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Assessment method [1]
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Timepoint [1]
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Over 12 months post coronary haemodynamics study.
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Secondary outcome [2]
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Major adverse cardiovascular events (MACE): Cardiovascular death, myocardial infarction and stroke. (Composite endpoint)
The information will be obtained from linkage to medical records.
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Assessment method [2]
341511
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Timepoint [2]
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Over 12 months post coronary haemodynamics study.
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Eligibility
Key inclusion criteria
1. Clinical diagnosis of angina
2. Persistent angina
3. Coronary angiography demonstrating normal or no obstructive coronary disease (<50% diameter stenosis)
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Admission for an acute coronary syndrome within the preceding month
2. Prior coronary artery bypass grafting
3. Contra-indications to coronary haemodynamic assessment - patients with permanent pacemaker or defibrillator, severe renal or hepatic insufficiency, severe asthma, left ventricular systolic dysfunction (ejection fraction <50%)
4. Alternative coronary explanations for the chest pain - obstructive coronary artery disease (flow limiting coronary stenosis i.e. derived fractional flow reserve (FFR) <0.80), spontaneous coronary spasm (but not catheter related spasm), spontaneous coronary artery dissection
5. Other cardiovascular disorders - pulmonary hypertension, pulmonary embolism, hypertrophic cardiomyopathy, or valvular heart disease.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Sample size is calculated on the principle of a minimum of 10 events per each predictor variable. Results will be expressed as mean +/- SD for normally distributed data and median (25th–75th percentiles) for data that were not normally distributed. Fisher-Exact test will be used to assess for differences between categorical variables. Student-t tests or Mann Whitney rank-sum tests will be used to assess for differences between groups for continuous variables. Logistic regression model will be fitted to identify the determinants of recurrent chest pain. Variables that are significantly associated with chest pain at p<0.20 in univariate analysis will be selected for inclusion in multivariate logistic regression. The final independent predictors were identified using backward elimination. P-value of = 0.05 will be considered statistically significant.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/02/2018
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Actual
1/02/2018
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Date of last participant enrolment
Anticipated
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Actual
5/11/2020
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Date of last data collection
Anticipated
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Actual
29/01/2021
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Sample size
Target
100
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Accrual to date
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Final
42
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment postcode(s) [1]
18374
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5112 - Elizabeth Vale
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Cardiology Unit, Lyell McEwin Hospital, Internal Research Fund
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Address [1]
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Haydown Rd, Elizabeth Vale SA 5112
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Country [1]
298110
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Australia
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Primary sponsor type
University
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Name
University of Adelaide
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Address
Department of Medicine
Graduate centre
Level 2, Schulz Building,
The University of Adelaide SA 5005
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
297386
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Country [1]
297386
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299129
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TQEH/LMH/MH Human Research Ethics Committee and Northern Adelaide Local Health Network, NALHN Research Governance
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Ethics committee address [1]
299129
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Ground Floor, Basil Hetzel Institute for Medical Research, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South SA 5011
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Ethics committee country [1]
299129
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Australia
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Date submitted for ethics approval [1]
299129
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14/08/2017
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Approval date [1]
299129
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07/11/2017
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Ethics approval number [1]
299129
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HREC/17/TQEH/156
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Summary
Brief summary
About 20-30% of patients with angina have no obstructive coronary artery disease on coronary angiogram (NoCAD). Despite no significant obstructive coronary artery disease, most of these patients continue to experience recurrent chest pain without any definitive diagnosis. Main aim of this study is to investigate patients with angina and NoCAD with a comprehensive invasive coronary and peripheral haemodynamic studies at the time of diagnostic coronary angiogram and to evaluate the prevalence of various coronary vasomotor disorders in these patients. Further, we aim to relate the results of testing to outcome by determining the clinical and coronary haemodynamic predictors of recurrent chest pain on 1, 6 and 12 months follow up.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
2300
2300
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/AnzctrAttachments/374085-Approval%20Letter%20-%20Arstall%20NOCAD%20Project%20A%20-%20Q20170706.pdf
(Ethics approval)
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Attachments [2]
2301
2301
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/AnzctrAttachments/374085-SSA%2017%20NALHN%2098%20%20Final%20Authorisation.pdf
(Other)
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Contacts
Principal investigator
Name
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A/Prof Margaret Arstall
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Address
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Cardiology Unit, Lyell McEwin Hospital, Northern Adelaide Local Health Network (NALHN)
Haydown Rd, Elizabeth Vale SA 5112
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Country
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Australia
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Phone
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+61 8 81829439
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Fax
79398
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+61 8 82820706
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Email
79398
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[email protected]
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Contact person for public queries
Name
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Dr Sharmalar Rajendran
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Address
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Cardiology Unit, Lyell McEwin Hospital, Northern Adelaide Local Health Network (NALHN)
Haydown Rd, Elizabeth Vale SA 5112
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Country
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Australia
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Phone
79399
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+61 8 81829439
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Fax
79399
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+61 8 82820706
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Email
79399
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[email protected]
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Contact person for scientific queries
Name
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Prof John Beltrame
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Address
79400
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Discipline of Medicine, The University of Adelaide, The Queen Elizabeth Hospital 28, Woodville Rd, Woodville South, South Australia 5011,
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Country
79400
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Australia
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Phone
79400
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+61 8 82226740
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Fax
79400
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+61 8 82227201
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Email
79400
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[email protected]
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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?
A limited, de-identified set of data available for researchers outside the primary investigators and will be specified in the data sharing plan.
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When will data be available (start and end dates)?
No end date determined. Two years after the publication of the primary results of the study. The endpoint of the availability to be specified by the investigators.
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Available to whom?
Researchers outside the primary investigators.
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Available for what types of analyses?
The type of analyses must be specified in the data sharing agreement between the providing agency and the requesting researchers.
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How or where can data be obtained?
Before data are shared, a data-sharing agreement should be established documenting what data are being shared and how the data can be used. The agreement serves two purposes. First, it protects the agency providing the data, ensuring that the data will not be misused. Second, it prevents miscommunication on the part of the provider of the data and the agency receiving the data by making certain that any questions about data use are discussed. The following items should be covered in the data-sharing agreement:
Period of agreement
The intended use of the data
Constraints on the use of the data
Data confidentiality
Data security
Methods of data-sharing
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
1055
Informed consent form
374085-(Uploaded-14-01-2019-16-14-07)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Ooi EL, Rajendran S, Munawar DA, Hnin K, Mahadavan...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
The Association of Obstructive Sleep Apnea in Ischemia with No Obstructive Coronary Artery Disease - A Pilot Study.
2023
https://dx.doi.org/10.1016/j.cpcardiol.2022.101111
N.B. These documents automatically identified may not have been verified by the study sponsor.
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