Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000386336
Ethics application status
Approved
Date submitted
7/07/2008
Date registered
1/08/2008
Date last updated
1/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ruling-out Coronary Artery Disease utilising non-invasive investigations in place of Invasive Coronary Angiography: a comparison between Computer Tomography Angiography and Myocardial Perfusion Imaging in patients with an intermediate probability of coronary artery disease
Scientific title
In patient groups with an intermediate probability of coronary artery disease is there a difference between computer tomography coronary angiography and myocardial perfusion imaging in ruling out significant coronary artery disease
Universal Trial Number (UTN)
Trial acronym
RoCAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 3370 0
Condition category
Condition code
Cardiovascular 3522 3522 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Computer Tomography Coronary Angiography (CTCA) or Coronary CT is a new technique which involves injecting dye into an arm vein and performing a specialised x-ray of the heart called a CT scan. While CT scans have been extensively used to image many organs, it is only recently that the technology has evolved to be fast enough to scan a beating heart. It is important for test accuracy that the heart is beating in a regular rhythm so that the scan can give the best results. This means that you will be given a medication (called a beta-blocker) to slow your heart down before the test. These same tablets are regularly used to treat coronary heart disease, and your specialist is very familiar with their use. Like the Nuclear Medicine study, the Coronary CT does not have the coronary angiography hazards associated with the placement of catheters but appears to have similar accuracy to angiography. Patients randomised to the CTCA test will undergo one CTCA.
Intervention code [1] 3101 0
Diagnosis / Prognosis
Comparator / control treatment
Myocardial Perfusion Imaging involves injecting a radioactive material into the blood via a small needle in the arm or hand after stimulating the heart either by an exercise test or injecting a drug. The heart is then scanned with a specialised camera to see how much of the radioactive material has gone into the heart muscle. If there is a reduced amount of radioactivity in the heart muscle then this implies that there are blockages within the coronary arteries we can then determine approximately how many of the coronary arteries are blocked. This test does not involve the hazards of placing catheters into the coronary arteries and thus is considerably safer than coronary angiography but is also less accurate. Patients randomised to the Myocardial Perfusion Imaging test will undergo just one scan.
Control group
Active

Outcomes
Primary outcome [1] 4425 0
The primary endpoint of this study is the number of Invasive Selective Coronary Angiography (ISCA) undertaken in each group within 6 months of the randomised diagnostic test
Timepoint [1] 4425 0
6 months post imaging
Secondary outcome [1] 7467 0
Total number of additional invasive/non-invasive Coronary Artery Disease (CAD) imaging studies in the 6 months following the randomised diagnostic test.
Timepoint [1] 7467 0
6 months post imaging
Secondary outcome [2] 7468 0
Cardiologist satisfaction as determined by Cardiologist Feedback Form scores
Timepoint [2] 7468 0
1 month post imaging
Secondary outcome [3] 7469 0
Patient satisfaction as determined by Patient Post-test Feedback Form scores
Timepoint [3] 7469 0
1 and 6 months post imaging
Secondary outcome [4] 7470 0
Patient 6 month progress as determined by; (a) Patient 6 month Follow-up Form scores, (b) SF-36 physical and mental health summary scores, and (c) Seattle Angina Questionnaire domain scores.
Timepoint [4] 7470 0
baseline and 6 months post imaging
Secondary outcome [5] 7471 0
Cost-effectiveness Evaluation. This will be measured by the number of ISCA studies avoided by undergoing less invasive and costly CTCA scans.
Timepoint [5] 7471 0
end of study - 6 months after the patients scan (either CTCA of Myocardial Perfusion Imaging)

Eligibility
Key inclusion criteria
Patient fulfilling all of the following criteria (a, b & c) will be considered: a) Intermediate pre-test probability of CAD (10-70%), ie Men = 40 years without typical angina Women = 60 years without typical angina; b) One of the following clinical presentation: 1) Chest pain with Left Bundle Branch Block (LBBB), or 2) Equivocal exercise test (ie Duke Treadmill Score -10 to 4), or 3) Suspected Dilated Cardiomyopathy (ie Unexplained global left ventricular systolic dysfunction) and c) Treating-cardiologist would undertake ISCA if these non-invasive tests were not available.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with following features will be excluded from the study: 1) Patients with high pre-test probability of CAD ( > 70%), ie those with typical angina, 2) Patients with low pre-test probability of CAD ( < 10%) including those with normal coronary angiography within the past 2 years, 3) Previously Documented CAD, ie. Previous myocardial infarction, Previous revascularisation therapy (Percutanious Coronary Intervention or Coronary Artery Bypass Graft) Previous coronary angiography demonstrating > 50% stenosis or Regional wall motion abnormality 4) Contra-indications to undertaking CTCA or MPI such as: Contrast allergy, Pregnancy, suspected pregnancy, Contra-indications to beta-blockers (asthma), Absence of sinus rhythm, Renal Impairment (Creatinine = 180 umol/L or eGFR < 50ml/min) or Thyroid Stimulating Hormone (TSH) < 0.36 mU/L

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)
Recruiting Cardiologists identify appropriate patients fulfilling the above criteria
Informed patient consent obtained
Cardiologist contacts QE Imaging Receptionist and notify them of the patient’s participation in the study
The Pre-randomisation Checklist will be completed. Items 1-4 will be completed by the QE Imaging Staff and assign the Patient Identification Code.
Randomisation by QE Imaging Staff using the sealed envelope system. This system utilises a 6 patient block design stratified per referring cardiologist.
The cardiologist will be informed of the study randomisation and a booking will be made by the QE Imaging Reception for CTCA or Stress MPI as required. The CTCA studies will be booked in for a Friday.
The QE Imaging Reception will notify the Study Co-ordinator as to the patient’s recruitment into the study and forward the Pre-randomisation Checklist.
The Study Co-ordinator will arrange to meet with the patient prior to the diagnostic test to ensure the Pre-randomisation Checklist is completed, including providing the patient with the Patient Information Sheet and obtaining a signed patient informed consent. Also during this meeting, clinical details for the Case Report Form will obtained and the patient will complete the quality of life surveys (SF-36 & Seattle Angina Questionnaire).
(PLEASE NOT 'QE' is a correct name, as is SF-36)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A total of 50 Computer Tomography Coronary Angiogram (CTCA) and 50 Myocardial Perfusion Imaging (MPI) slips were written and placed into envelops. 5 CTCA and 5 MPI envelops were then labelled with consultant number 1. 3 of each of these two groups were then taken and shuffled and labelled consultant 1, envelop number 1 through 6 and placed in the front of a devided box. The remaining 4 envelops were also shuffled and then labelled consultant 1 number 7 through 10 and placed with the first 6 envelopes. This process was repeated until there were 10 groups of 10 envelops
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3557 0
Other
Name [1] 3557 0
BUPA Australia
Country [1] 3557 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
Woodville Road
Woddville 5011
Country
Australia
Secondary sponsor category [1] 3195 0
None
Name [1] 3195 0
Address [1] 3195 0
Country [1] 3195 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5599 0
Ethics of Human Research Committee (TQEH & LMH)
Ethics committee address [1] 5599 0
Ethics committee country [1] 5599 0
Australia
Date submitted for ethics approval [1] 5599 0
17/01/2008
Approval date [1] 5599 0
25/02/2008
Ethics approval number [1] 5599 0
2007154

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

Contacts
Principal investigator
Name 28729 0
Address 28729 0
Country 28729 0
Phone 28729 0
Fax 28729 0
Email 28729 0
Contact person for public queries
Name 11886 0
Jennifer Cranefield
Address 11886 0
The Queen Elizabeth Hospital
Radiolgy Department
Ground Floor
Woodville Rad
Woddville 5011
Country 11886 0
Australia
Phone 11886 0
08 8222 6894
Fax 11886 0
Email 11886 0
[email protected]
Contact person for scientific queries
Name 2814 0
John Beltrame
Address 2814 0
The Queen Elizabeth Hospital
Cardiology Department
Level 3
Woodville Road
Woodville 5011
Country 2814 0
Australia
Phone 2814 0
08 8222 7632
Fax 2814 0
Email 2814 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.