Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000630617
Ethics application status
Approved
Date submitted
20/03/2014
Date registered
13/06/2014
Date last updated
13/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Diagnostic Performance and Cost of Cardiac Computed Tomographic Angiography versus Stress Electrocardiography – a Randomized Prospective Study of Suspected Acute Coronary Syndrome Chest Pain in the Emergency Department
Scientific title
A single centre, randomised, unblinded, prospective trial on the diagnostic performance and cost of coronary computed tomographic angiography compared to exercise stress angiography in patients presenting to the emergency department with chest pain suspected of acute coronary syndrome.
Secondary ID [1] 284298 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
CT-COMPARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 291444 0
Chest Pain 291445 0
Condition category
Condition code
Cardiovascular 291818 291818 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Coronary Computed Tomographic Angiography: electrocardiographically gated computed tomography of the heart with venous injection of iodinated contrast in order to evaluate the presence/absence of coronary artery disease. Subjects will be randomized to receive this diagnostic test once, as compared to standard of care. Duration of the test is 15-30 minutes.
Intervention code [1] 289021 0
Diagnosis / Prognosis
Comparator / control treatment
Exercise Treadmill stress electrocardiography according to the Bruce treadmill protocol; briefly, subjects with a second negative 6-hour troponin for myocardial infarction (Troponin I <0.04 mg/dl) underwent standard Bruce treadmill protocol using graded exercise on a standard treadmill with continuous ECG monitoring (Marquette, GE Healthcare). A cardiology registrar/fellow performed continuous ECG and vital sign monitoring during ExECG testing. A cardiologist independently adjudicated the ExECG result using standard criteria for myocardial ischemia. Subjects without ExECG evidence of myocardial ischemia were discharged. Subjects with positive or equivocal ExECG results were managed at the discretion of the treating cardiologist
Control group
Active

Outcomes
Primary outcome [1] 291735 0
Acute Coronary Syndrome: diagnostic performance. The cause of subjects’ presenting symptoms is determined by adjudicated diagnosis using all available data including 30 day follow-up. Two board-certified cardiologists audited each patient chart and adjudicated the presence of ACS using case report forms based on Cardiac Society of Australia and New Zealand Guidelines. Differences were resolved by consensus
Timepoint [1] 291735 0
At 30 days post randomisation and re-assessed at 5 years where applicable.
Primary outcome [2] 291736 0
Cost, from a hospital perspective. The costs and length of stay were calculated using time stamps in trial data forms and from hospital systems. Total patient ED utilization costs for the ED and hospital stay, including 30 days after index admission, were tabulated for each patient. The costing methodology included direct costs associated with patient treatment for all inpatient and outpatient care related to the index admission. This encompassed labor cost (time per patient utilization for nursing and medical time), diagnostic imaging, pathology and pharmaceuticals cost, bed day costs (based on the fractional length of stay of the patient and ward location) and non-labor costs (including consumables). Average cost was then calculated for each trial arm are reported in 2012 $AUD values. Societal or opportunity costs were not included in this evaluation.
Timepoint [2] 291736 0
At 30 days post randomisation
Secondary outcome [1] 307369 0
time-to-discharge from the hospital as determined by hospital records systems (EDIS, HBSCIS and manual interrogation of hospital charts).
Timepoint [1] 307369 0
At discharge from hospital
Secondary outcome [2] 307370 0
major adverse cardiovascular events (MACE) determined by review of participant medical records All enrolled subjects provided consent for nurse follow up by telephone interview at least 30 days after presentation and at 12 months using a structured questionnaire. Data are captured on hospital presentations for chest pain, additional cardiac testing, diagnosis of ACS, and visits to physicians related to the index hospitalization.;
major adverse cardiovascular events is defined as; acute myocardial infarction; ischaemic stroke; recurrent ACS or requirement for revascularization (PCI or CABG), cardiac death;
Timepoint [2] 307370 0
At 30 days and 12 months post randomisation
Secondary outcome [3] 307371 0
downstream resource utilization:Total patient ED utilization costs for the ED and hospital stay, including 30 days after index admission, were tabulated for each patient. The costing methodology included direct costs associated with patient treatment for all inpatient and outpatient care related to the index admission. This encompassed labor cost (time per patient utilization for nursing and medical time), diagnostic imaging, pathology and pharmaceuticals cost, bed day costs (based on the fractional length of stay of the patient and ward location) and non-labor costs (including consumables).
Timepoint [3] 307371 0
At 30 days post randomisation
Secondary outcome [4] 307372 0
repeat presentation for recurrent symptoms as determined by telephone follow-up and review of participant medical records
Timepoint [4] 307372 0
At 12 months post randomisation

Eligibility
Key inclusion criteria
Males greater or equal to 30 and females greater or equal to 40 years of age presenting to the ED with acute undifferentiated chest pain were eligible for inclusion in the trial. Inclusion criteria included intermediate probability of coronary artery disease according to the Cardiac Society of Australia and New Zealand guidelines; initial 12-lead ECG without evidence of acute ischemia, TIMI (Thrombolysis in Myocardial Infarction) risk score <4 and a negative first serum sensitive troponin-I with a 99th centile at <0.04 ng/ml (Access 2 immunoassay, Beckman-Coulter)
Minimum age
30 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were previous diagnosis of coronary artery disease; confirmed pregnancy or lactating female; history of severe reactive airway disease or current exacerbation; allergy or contraindication to iodinated contrast or beta-blockade medications; current atrial fibrillation; renal impairment (eGFR < 50ml/minute using the MDRD equation). To be eligible for randomization, subjects needed to be pain-free and potentially able to exercise on a treadmill.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Males greater or equal to 30 and females greater or equal to 40 years of age presenting to the ED with acute undifferentiated chest pain were eligible for inclusion in the trial.

Allocation was performed by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). randomization occurred after the first negative serum troponin result
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
different groups of participants receive different interventions during the same time span of the study: an intervention group (i.e. Coronary Computed Tomographic Angiography) and a comparator group (i.e. Exercise Treadmill stress ECG)
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The study sample size was calculated based on a false negative rate of ExECG-based care up to 6% and lower limits of CTCA-based care from ROMICAT 1 trial of 2%. Using a one sided two sample proportions test with a delta of 0.04 and an alpha equal to 0.05, there was 80% power to detect a difference with an estimated sample size of 592 patients. Variables are expressed as mean +/- 95% confidence interval (CI) or as number and percentages for binary and categorical variables. Analyses for continuous variables were compared using unpaired student t-test for parametric data and Mann-Whitney U test for non-parametric data. Binary data were compared by chi-squared testing. ROC area under the curve (AUC) was compared between trial arms using the c-statistic. Odds ratios were tabulated using logistic regression. All outcome data were considered as intention-to-treat analyses. Statistics were calculated using Microsoft EXCEL (Redmond, WA, USA) or STATA SE software (College Station, PA, USA).
Statistics performed by the Clinical Trials and Support Unit, University of Washington, Seattle, WA, United States

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
11/01/2010
Actual
11/01/2010
Date of last participant enrolment
Anticipated
30/04/2011
Actual
30/04/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
592
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2210 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 7888 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 288928 0
Charities/Societies/Foundations
Name [1] 288928 0
Queensland Emergency Medicine Research Foundation (#QEMRF-EMSS-2009-022),
Country [1] 288928 0
Australia
Funding source category [2] 288929 0
Government body
Name [2] 288929 0
Smart Futures Fellowship Early Career Grant (#ISF783)
Country [2] 288929 0
Australia
Funding source category [3] 288930 0
University
Name [3] 288930 0
Washington-Queensland Trans-Pacific Fellowship fund
Country [3] 288930 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Queensland Emergency Medicine Research Foundation
Address
Queensland Emergency Medicine Research Foundation
2/15 Lang Parade, Milton QLD 4064
Country
Australia
Secondary sponsor category [1] 287620 0
Government body
Name [1] 287620 0
Smart Futures Fund
Address [1] 287620 0
Department of Science, Information Technology, Innovation and the Arts, Queensland State Government.
Postal address:
GPO Box 5078
BRISBANE QLD 4001
Country [1] 287620 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290756 0
Prince Charles Hospital
Ethics committee address [1] 290756 0
Ethics committee country [1] 290756 0
Australia
Date submitted for ethics approval [1] 290756 0
Approval date [1] 290756 0
01/10/2009
Ethics approval number [1] 290756 0
HREC/09/QPCH/89

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47098 0
A/Prof Christian Hamilton-Craig
Address 47098 0
The Prince Charles Hospital
Echocardiography Unit
CIU Ground Floor
Rode Road,
Chermside 4032
Queensland
Country 47098 0
Australia
Phone 47098 0
61731394000
Fax 47098 0
Email 47098 0
[email protected]
Contact person for public queries
Name 47099 0
Jane Bebbington
Address 47099 0
Media Office and Public Relations
The Prince Charles Hospital
Administration Building
Rode Road,
Chermside
Queensland 4032
Country 47099 0
Australia
Phone 47099 0
61731394000
Fax 47099 0
Email 47099 0
[email protected]
Contact person for scientific queries
Name 47100 0
Christian Hamilton-Craig
Address 47100 0
The Prince Charles Hospital
Echocardiography Unit
CIU Ground Floor
Rode Road,
Chermside
Queensland 4032
Country 47100 0
Australia
Phone 47100 0
61731394000
Fax 47100 0
Email 47100 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Int J Cardiol. 2014 Dec 20;177(3):867-73. doi: 10.... [More Details] 366010-(Uploaded-23-07-2019-20-39-57)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.