Clinical evaluation of MAgnetic Resonance imaging in Coronary heart disease
| ISRCTN | ISRCTN77246133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77246133 |
| Protocol serial number | N/A |
| Sponsor | British Heart Foundation |
| Funders | British Heart Foundation (UK), Leeds General Infirmary (LGI) Challenge Fund (UK) |
- Submission date
- 07/02/2006
- Registration date
- 21/02/2006
- Last edited
- 17/07/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr JP Greenwood
Scientific
Scientific
Senior Lecturer & Consultant Cardiologist
Leeds University & Leeds Teaching Hospitals NHS Trust
Department of Cardiology
G Floor, Jubilee Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 392 5404 |
|---|---|
| j.greenwood@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised cross-over study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Clinical evaluation of MAgnetic Resonance imaging in Coronary heart disease |
| Study acronym | Ce-MARC |
| Study objectives | Approximately 2.5 million people in the UK suffer from the symptoms of CHD. Currently patients with CHD undergo a number of tests, including angiography, which carries a small but significant risk. It is anticipated that the new test of Cardiac Magnetic Resonance Imaging (CMRI) will be more reliable in identifying those patients who would benefit from a bypass or angioplasty than current non-invasive tests. This research programme will include the first large-scale prospective evaluation of a validated comprehensive CMRI imaging protocol compared to the standard non-invasive tests Exercise Treadmill Testing (ETT) and Single Photon Emission Computed Tomography (SPECT) for the diagnosis of suspected Coronary Heart Disease (CHD) with x-ray coronary angiography as the reference standard. Patient follow up will provide much needed prognostic data for CMRI, and a health economic evaluation and assessment of patient preference will be performed for the different investigation strategies. |
| Ethics approval(s) | Ethics approval received from the Leeds West Research Ethics Committee, 24/08/2005, ref: 05/Q1205/126 |
| Health condition(s) or problem(s) studied | Coronary heart disease |
| Intervention | Comparing non-invasive techniques for diagnosing coronary artery disease (ETT, SPECT and CMR) against invasive angiography. Patients who agree to take part in the study will initially undergo three investigations: ETT and then in random order, cardiac Magnetic Resonance Imaging (MRI) and SPECT imaging. After all three tests have been completed, all patients will undergo x-ray angiography. |
| Intervention type | Other |
| Primary outcome measure(s) |
The diagnostic performance of MRI to detect significant CHD on x-ray angiography |
| Key secondary outcome measure(s) |
1. The diagnostic performance of current standard clinical investigations of ETT and SPECT |
| Completion date | 27/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 750 |
| Key inclusion criteria | 1. Ages between 35 and 79 years 2. Weight less than 110 kg 3. Suitable for coronary revascularisation if required 4. Clinically stable 5. In sinus rhythm |
| Key exclusion criteria | 1. Previous revascularisation 2. Evidence of crescendo angina or acute coronary syndrome 3. Contraindication to MRI imaging (pacemaker, intraorbital debris, intraauricular implants, intracranial clips) 4. Contraindication to adenosine infusion (regular adenosine antagonist medication, asthma/chronic obstructive pulmonary disease, second or third degree atrioventricular heart block, sino-atrial disease) 5. Aged less than 35 years 6. Weight greater than 100 kg 7. Non-sinus rhythm 8. Resting heart rate greater than 100 /min 9. Frequent ventricular ectopy (greater than 3 Ventricular Premature Beats [VPB] per minute) 10. Pregnancy 11. Known adverse reaction to adenosine or gadolinium contrast agent 12. Inability to lie supine for 60 minutes 13. Known chronic renal insufficiency |
| Date of first enrolment | 27/02/2006 |
| Date of final enrolment | 27/02/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leeds University & Leeds Teaching Hospitals NHS Trust
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/03/2014 | Yes | No | |
| Results article | results | 15/07/2015 | Yes | No | |
| Protocol article | protocol | 29/07/2009 | Yes | No | |
| Other publications | prospective trial | 04/02/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
