Condition category
Circulatory System
Date applied
07/02/2006
Date assigned
21/02/2006
Last edited
17/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.leedscmr.org

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 measures

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

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

http://www.bhf.org.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes