Clinical evaluation of MAgnetic Resonance imaging in Coronary heart disease

ISRCTN	ISRCTN77246133
DOI	https://doi.org/10.1186/ISRCTN77246133
Secondary identifying numbers	N/A

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

Study website

Contact information

Dr JP Greenwood
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
Email	j.greenwood@leeds.ac.uk

Study information

Study design	Randomised cross-over study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	27/02/2006
Completion date	27/02/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Leeds University & Leeds Teaching Hospitals NHS Trust

Leeds
LS1 3EX
United Kingdom

Sponsor information

British Heart Foundation
Charity

14 Fitzhardinge Street
London
W1H 6DH
United Kingdom

Phone	+44 (0)207 9350185
Email	research@bhf.org.uk
Website	http://www.bhf.org.uk/
"ROR"	https://ror.org/02wdwnk04

Funders

Funder type

Charity

British Heart Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): the_bhf, The British Heart Foundation, BHF
Location: United Kingdom

Leeds General Infirmary (LGI) Challenge Fund (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	29/07/2009	Yes	No
Other publications	prospective trial	04/02/2012	Yes	No
Results article	results	11/03/2014	Yes	No
Results article	results	15/07/2015	Yes	No