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Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease-2 (CE-MARC2)

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ClinicalTrials.gov Identifier: NCT01664858
Recruitment Status : Unknown
Verified March 2015 by Professor JP Greenwood, University of Leeds.
Recruitment status was:  Active, not recruiting
First Posted : August 14, 2012
Last Update Posted : March 30, 2015
Sponsor:
Collaborators:
University of Leicester
University of Glasgow
British Heart Foundation
Information provided by (Responsible Party):
Professor JP Greenwood, University of Leeds

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Other: 3T CMR Other: SPECT Other: CT calcium score Other: CT coronary angiography Other: X-Ray coronary angiography Phase 4

Detailed Description:

The study is a randomized controlled trial of non-invasive imaging to determine diagnosis and management of patients presenting with suspected stable angina. Despite the widespread availability of non-invasive imaging and guideline-enshrined use of optimal medical therapy (OMT), patients with suspected coronary heart disease (CHD) often end up having invasive coronary angiography early in their disease course. Currently >50% of elective invasive coronary angiograms performed in the UK and US do not lead on to a revascularisation procedure (data from 2008-09 UK Hospital Episode Statistics; American College of Cardiology National Cardiovascular Data Registry (Patel MR, et al., N Engl J Med 2010;362:886-95)). The UK NICE guidelines for the management of chest pain of recent onset (CG95; 2010) could increase this proportion even further. This is inefficient for patients and also of healthcare resources.

More widespread use of non-invasive functional imaging could reduce the rates of unnecessary angiography. We have shown in the CE-MARC study (Lancet 2012) that cardiovascular magnetic resonance (CMR) at 1.5Tesla has a higher diagnostic accuracy for the detection of CHD than single-photon emission computed tomography (SPECT). CE-MARC 2 will be a three-way randomised controlled trial of patient management in 1200 patients with known or suspected CHD, comparing 3Tesla CMR to SPECT-guided care or NICE guidelines-based management. The primary endpoint will be the reduction of unnecessary invasive angiography (defined by invasive FFR) at 12 months - identified by our expert patients as an important 'patient focused' clinical outcome measure. The secondary objectives will include: 1) assessment of safety of a CMR-guided management strategy 2) cost effectiveness analysis of these strategies.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease - 2 (CE-MARC2)
Study Start Date : November 2012
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2018

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 3T CMR-guided management
Patient to be managed according to the results of 3T CMR imaging
 Other: 3T CMR
3Tesla Cardiac Magnetic Resonance Imaging
Other: X-Ray coronary angiography
X-Ray coronary angiography
Active Comparator: SPECT-guided management
Patients to be managed according to the results of SPECT
 Other: SPECT
SPECT: Single Photon Emission Computed Tomography
Other: X-Ray coronary angiography
X-Ray coronary angiography
Active Comparator: NICE-guidelines based management

Patients 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

 Other: SPECT
SPECT: Single Photon Emission Computed Tomography
Other: CT calcium score
CT calcium score
Other: CT coronary angiography
CT coronary angiography
Other: X-Ray coronary angiography
X-Ray coronary angiography


Outcome Measures
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Primary Outcome Measures :
  1. Unnecessary invasive coronary angiography [ Time Frame: 12 months ]
    • 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


Secondary Outcome Measures :
  1. Major adverse cardiovascular event (MACE) [ Time Frame: at 12 months and at 3 years ]

    MACE is defined as one of the following:

    • Death due to cardiovascular cause (including type 3 MI) †
    • Myocardial infarction†
    • Unplanned revascularisation
    • Hospital admission for cardiovascular cause [ACS Troponin -ve, spontaneous myocardial infarction (Type 1)†, Myocardial infarction secondary to ischaemic imbalance (Type 2) †, Myocardial Infarction related to stent thrombosis (Type 4b) †, Arrhythmia, Stroke, Heart failure]. † As defined by the third universal definition of myocardial infarction.

  2. Positive angiogram (by FFR) rate for each strategy. [ Time Frame: 12 months ]
    The Positive Angiogram rate will be determined from the proportion of patients in the relevant population who undergo an angiogram within 12 months of randomisation which yields a positive finding by FFR (or QCA where no FFR reading is undertaken)

  3. Cost effectiveness analysis [ Time Frame: 3 years ]
    To assess the long term cost-effectiveness of the alternate diagnostic testing strategies, information from the trial will be used to update the economic model developed as part of the original CE-MARC trial. The model will use information from the trial, including on resource use, costs, HRQoL and other clinical outcomes (e.g. on unnecessary tests and MACE events), together with epidemiological, clinical and economic data from other sources to calculate costs and quality-adjusted life-years (QALYs) for patients. The economic analysis will use methods consistent with those recommended by the National Institute for Health and Clinical Excellence (NICE). Given the potential difference between diagnostic strategies in terms of mortality, the modelling will adopt a lifetime time horizon to capture any difference.

  4. Health-related quality-of-life measures (SAQ-UK; SF12; EQ-5D) [ Time Frame: 3 years ]

    Health-related quality-of-life (HRQoL) will be measured at baseline (in clinic), 6 months, 12 months, 2yrs and 3yrs (by post), using the following validated questionnaires:

    • Seattle Angina Questionnaire (SAQ) - UK version
    • SF12v2
    • EuroQol (EQ-5D)

  5. Complications [ Time Frame: 3 years ]
    Complications - investigational or procedural related only. All complications from all study procedures/investigations will be recorded and reported if they result in an extended length of stay or specific treatment.


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664858


Locations
United Kingdom
Glenfield Hospital
Leicester, Leicestershire, United Kingdom, LE3 9QP
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS1 3EX
University Hospitals Bristol NHS FT
Bristol, United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom, G81 4HX
St Georges Healthcare NHS Trust
London, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, United Kingdom
Sponsors and Collaborators
University of Leeds
University of Leicester
University of Glasgow
British Heart Foundation
Investigators
Principal Investigator: John P Greenwood, PhD University of Leeds
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Leeds CMR clinical research group website  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor JP Greenwood, Professor of Cardiology, University of Leeds
ClinicalTrials.gov Identifier: NCT01664858     History of Changes
Other Study ID Numbers: SP/12/1/29062
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015

Keywords provided by Professor JP Greenwood, University of Leeds:
Coronary Heart Disease
Ischaemic Heart Disease
Angina
Cardiac Magnetic Resonance Imaging

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs