Contact information
Type
Scientific
Primary contact
Dr JP Greenwood
ORCID ID
Contact details
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
+44 (0)113 392 5404
j.greenwood@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Clinical evaluation of MAgnetic Resonance imaging in Coronary heart disease
Acronym
Ce-MARC
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.
Ethics approval
Ethics approval received from the Leeds West Research Ethics Committee, 24/08/2005, ref: 05/Q1205/126
Study design
Randomised cross-over study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
The diagnostic performance of MRI to detect significant CHD on x-ray angiography
Secondary outcome measures
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
Overall trial start date
27/02/2006
Overall trial end date
27/02/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
750
Participant 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
Recruitment start date
27/02/2006
Recruitment end date
27/02/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds University & Leeds Teaching Hospitals NHS Trust
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
British Heart Foundation
Sponsor details
14 Fitzhardinge Street
London
W1H 6DH
United Kingdom
+44 (0)207 9350185
research@bhf.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (UK)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
Funder name
Leeds General Infirmary (LGI) Challenge Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19640271
2012 prospective trial in: http://www.ncbi.nlm.nih.gov/pubmed/22196944
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24357404
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26174854
Publication citations
-
Protocol
Greenwood JP, Maredia N, Radjenovic A, Brown JM, Nixon J, Farrin AJ, Dickinson C, Younger JF, Ridgway JP, Sculpher M, Ball SG, Plein S, Clinical evaluation of magnetic resonance imaging in coronary heart disease: the CE-MARC study., Trials, 2009, 10, 62, doi: 10.1186/1745-6215-10-62.
-
Prospective trial
Greenwood JP, Maredia N, Younger JF, Brown JM, Nixon J, Everett CC, Bijsterveld P, Ridgway JP, Radjenovic A, Dickinson CJ, Ball SG, Plein S, Cardiovascular magnetic resonance and single-photon emission computed tomography for diagnosis of coronary heart disease (CE-MARC): a prospective trial., Lancet, 2012, 379, 9814, 453-460, doi: 10.1016/S0140-6736(11)61335-4.
-
Results
Greenwood JP, Motwani M, Maredia N, Brown JM, Everett CC, Nixon J, Bijsterveld P, Dickinson CJ, Ball SG, Plein S, Comparison of cardiovascular magnetic resonance and single-photon emission computed tomography in women with suspected coronary artery disease from the Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease (CE-MARC) Trial., Circulation, 2014, 129, 10, 1129-1138, doi: 10.1161/CIRCULATIONAHA.112.000071.
-
Results
Ripley DP, Motwani M, Brown JM, Nixon J, Everett CC, Bijsterveld P, Maredia N, Plein S, Greenwood JP, Individual component analysis of the multi-parametric cardiovascular magnetic resonance protocol in the CE-MARC trial, J Cardiovasc Magn Reson, 2015 , 17, 59, doi: 10.1186/s12968-015-0169-2.