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17 May 2012
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| [ Print-friendly version ] |
| Clinical evaluation of MAgnetic Resonance imaging in Coronary heart disease |
| ISRCTN | ISRCTN77246133 |
| ClinicalTrials.gov identifier | |
| Public title | Clinical evaluation of MAgnetic Resonance imaging in Coronary heart disease |
| Scientific title | |
| Acronym | Ce-MARC |
| Serial number at source | N/A |
| Study hypothesis |
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. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Ethics approval received from the Leeds West Research Ethics Committee on the 24th August 2005 (ref: 05/Q1205/126). |
| Study design | Randomised cross-over study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Coronary heart disease |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 27/02/2006 |
| Anticipated end date | 27/02/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 750 |
| Interventions | 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. |
| Primary outcome measure(s) | The diagnostic performance of MRI to detect significant CHD on x-ray angiography |
| Secondary outcome measure(s) |
1. The diagnostic performance of current standard clinical investigations of ETT and SPECT
2. The cost effectiveness of CMRI in a diagnostic strategy for the systematic investigation of patients with suspected CHD 3. Patient’s preference of the different strategies for the investigation of suspected CHD |
| Sources of funding |
1. British Heart Foundation (UK)
2. Leeds General Infirmary (LGI) Challenge Fund (UK) |
| Trial website | http://www.leedscmr.org |
| Publications |
1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19640271
2. 2012 prospective trial in http://www.ncbi.nlm.nih.gov/pubmed/22196944 |
| Contact name | Dr JP Greenwood |
| Address |
Senior Lecturer & Consultant Cardiologist,
Leeds University & Leeds Teaching Hospitals NHS Trust, Department of Cardiology, G Floor, Jubilee Wing, Leeds General Infirmary, Great George Street, |
| City/town | Leeds |
| Zip/Postcode | LS1 3EX |
| Country | United Kingdom |
| Tel | +44 (0)113 392 5404 |
| j.greenwood@leeds.ac.uk | |
| Sponsor | British Heart Foundation |
| Address | 14 Fitzhardinge street |
| City/town | London |
| Zip/Postcode | W1H 6DH |
| Country | United Kingdom |
| Tel | +44 (0)207 9350185 |
| research@bhf.org.uk | |
| Sponsor website: | http://www.bhf.org.uk/ |
| Date applied | 07/02/2006 |
| Last edited | 21/03/2012 |
| Date ISRCTN assigned | 21/02/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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