Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease-2
CE-MARC2
1 other identifier
interventional
1,202
1 country
6
Brief Summary
CE-MARC 2 is a randomised controlled trial to determine diagnosis and patient management in patients presenting to outpatient clinics with suspected stable angina. Cardiac Magnetic Resonance Imaging (at 3Tesla) will be evaluated prospectively against current best clinical practice (defined by international guidelines). The study hypothesis is that 3Tesla CMR-guided management of patients with suspected stable angina is superior to current clinical practice based on 1) the principles of the National Institutes for Clinical Excellence (NICE) CG95 guidelines (2010); 2) SPECT AHA appropriateness criteria, in terms of avoiding study-defined unnecessary invasive coronary angiography.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2012
CompletedFirst Posted
Study publicly available on registry
August 14, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedResults Posted
Study results publicly available
November 23, 2018
CompletedNovember 23, 2018
May 1, 2018
3.3 years
August 10, 2012
October 27, 2016
May 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Unnecessary Invasive Coronary Angiography
* A negative FFR and positive non-invasive test (either 3T CMR or SPECT/CCT) * A negative FFR in a high pre-test risk (61-90%) patient that proceeds directly to invasive angiography in the NICE guidelines-based strategy arm * A negative FFR and a negative non-invasive test (either 3T CMR or SPECT/CCT) (i.e. a True Negative strategy result in which the imaging result was 'not believed' by the treating cardiologist) * An inconclusive non-invasive test result (either 3T CMR or SPECT/CCT) in which angiography had to be performed to make the diagnosis
12 months
Secondary Outcomes (5)
Major Adverse Cardiovascular Event (MACE)
at 12 months
Positive Angiogram (by FFR) Rate for Each Strategy.
12 months
Cost Effectiveness Analysis
3 years
Health-related Quality-of-life Measures (SAQ-UK; SF12; EQ-5D)
3 years
Complications
3 years
Study Arms (3)
3T CMR-guided management
ACTIVE COMPARATORPatient to be managed according to the results of 3T CMR imaging
SPECT-guided management
ACTIVE COMPARATORPatients to be managed according to the results of SPECT
NICE-guidelines based management
ACTIVE COMPARATORPatients will be receive NICE-guidelines based management and will receive the imaging strategy specified by NICE according to their pre-test likelihood of having CHD. 10-29% - CT calcium score +/- CT coronary angiography; 30-60% - SPECT; 61-90% - X-Ray coronary angiography
Interventions
SPECT: Single Photon Emission Computed Tomography
X-Ray coronary angiography
Eligibility Criteria
You may qualify if:
- Patient ≥30yrs
- Patient has suspected stable angina (CHD) that requires further investigation
- Has a defined risk of 10-90% (according to NICE guidelines CG95; 2010)
- Suitable for revascularisation if required
- Given informed written consent
You may not qualify if:
- Non-anginal chest pain
- Clinically unstable
- Previous MI or biomarker positive ACS
- Previous revascularisation with coronary artery bypass surgery or PCI
- Contraindication to CMR imaging (pacemaker, intra-orbital debris, intra-auricular implants, intracranial clips, severe claustrophobia)
- Contraindication to adenosine infusion (regular adenosine antagonist medication, significant reversible airways disease, second or third degree atrio-ventricular heart block, sino-atrial disease)
- Known adverse reaction to Adenosine or Gadolinium contrast agent
- Obesity (where body girth exceeds scanner diameter)
- Pregnancy or breast feeding
- Inability to give informed consent
- Known chronic renal failure (eGFR \<30mL/min/1.73m2)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leedslead
- University of Leicestercollaborator
- University of Glasgowcollaborator
- British Heart Foundationcollaborator
Study Sites (6)
Glenfield Hospital
Leicester, Leicestershire, LE3 9QP, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS1 3EX, United Kingdom
University Hospitals Bristol NHS FT
Bristol, United Kingdom
Golden Jubilee National Hospital
Glasgow, G81 4HX, United Kingdom
St Georges Healthcare NHS Trust
London, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, United Kingdom
Related Publications (4)
Ripley DP, Brown JM, Everett CC, Bijsterveld P, Walker S, Sculpher M, McCann GP, Berry C, Plein S, Greenwood JP. Rationale and design of the Clinical Evaluation of Magnetic Resonance Imaging in Coronary heart disease 2 trial (CE-MARC 2): a prospective, multicenter, randomized trial of diagnostic strategies in suspected coronary heart disease. Am Heart J. 2015 Jan;169(1):17-24.e1. doi: 10.1016/j.ahj.2014.10.008. Epub 2014 Oct 22.
PMID: 25497243BACKGROUNDGreenwood JP, Ripley DP, Berry C, McCann GP, Plein S, Bucciarelli-Ducci C, Dall'Armellina E, Prasad A, Bijsterveld P, Foley JR, Mangion K, Sculpher M, Walker S, Everett CC, Cairns DA, Sharples LD, Brown JM; CE-MARC 2 Investigators. Effect of Care Guided by Cardiovascular Magnetic Resonance, Myocardial Perfusion Scintigraphy, or NICE Guidelines on Subsequent Unnecessary Angiography Rates: The CE-MARC 2 Randomized Clinical Trial. JAMA. 2016 Sep 13;316(10):1051-60. doi: 10.1001/jama.2016.12680.
PMID: 27570866RESULTEverett CC, Berry C, McCann GP, Fernandez C, Reynolds C, Bucciarelli-Ducci C, Dall'Armellina E, Prasad A, Foley JR, Mangion K, Bijsterveld P, Brown J, Stocken D, Walker S, Sculpher M, Plein S, Greenwood JP. Randomised trial of stable chest pain investigation: 3-year clinical and quality of life results from CE-MARC 2. Open Heart. 2023 May;10(1):e002221. doi: 10.1136/openhrt-2022-002221.
PMID: 37130657DERIVEDCorcoran D, Young R, Adlam D, McConnachie A, Mangion K, Ripley D, Cairns D, Brown J, Bucciarelli-Ducci C, Baumbach A, Kharbanda R, Oldroyd KG, McCann GP, Greenwood JP, Berry C. Coronary microvascular dysfunction in patients with stable coronary artery disease: The CE-MARC 2 coronary physiology sub-study. Int J Cardiol. 2018 Sep 1;266:7-14. doi: 10.1016/j.ijcard.2018.04.061. Epub 2018 Apr 19.
PMID: 29716756DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor John P Greenwood
- Organization
- University of Leeds
Study Officials
- PRINCIPAL INVESTIGATOR
John P Greenwood, PhD
University of Leeds
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Cardiology
Study Record Dates
First Submitted
August 10, 2012
First Posted
August 14, 2012
Study Start
November 1, 2012
Primary Completion
March 1, 2016
Study Completion
March 1, 2018
Last Updated
November 23, 2018
Results First Posted
November 23, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share