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| Name | Class |
|---|---|
| University of Leicester | OTHER |
| University of Glasgow | OTHER |
| British Heart Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3T CMR-guided management | Active Comparator | Patient to be managed according to the results of 3T CMR imaging |
|
| SPECT-guided management | Active Comparator | Patients to be managed according to the results of SPECT |
|
| NICE-guidelines based management | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3T CMR | Other | 3Tesla Cardiac Magnetic Resonance Imaging |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Unnecessary Invasive Coronary Angiography |
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular Event (MACE) | MACE is defined as one of the following:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Greenwood, PhD | University of Leeds | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenfield Hospital | Leicester | Leicestershire | LE3 9QP | United Kingdom | ||
| Leeds Teaching Hospitals NHS Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25497243 | Background | 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. | |
| 27570866 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3T CMR-guided Management | Patient to be managed according to the results of 3T CMR imaging 3T CMR: 3Tesla Cardiac Magnetic Resonance Imaging X-Ray coronary angiography: X-Ray coronary angiography |
| FG001 | SPECT-guided Management |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| SPECT |
| Other |
SPECT: Single Photon Emission Computed Tomography |
|
| CT calcium score | Other | CT calcium score |
|
| CT coronary angiography | Other | CT coronary angiography |
|
| X-Ray coronary angiography | Other | X-Ray coronary angiography |
|
| at 12 months |
| Positive Angiogram (by FFR) Rate for Each Strategy. | 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) | 12 months |
| Cost Effectiveness Analysis | 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. | 3 years |
| Health-related Quality-of-life Measures (SAQ-UK; SF12; EQ-5D) | 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:
| 3 years |
| Complications | 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. | 3 years |
| 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 |
| Result |
| Greenwood 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. |
| 37130657 | Derived | Everett 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. |
| 29716756 | Derived | Corcoran 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. |
Patients to be managed according to the results of SPECT
SPECT: SPECT: Single Photon Emission Computed Tomography
X-Ray coronary angiography: X-Ray coronary angiography
| FG002 | 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 SPECT: SPECT: Single Photon Emission Computed Tomography CT calcium score: CT calcium score CT coronary angiography: CT coronary angiography X-Ray coronary angiography: X-Ray coronary angiography |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3T CMR-guided Management | Patient to be managed according to the results of 3T CMR imaging 3T CMR: 3Tesla Cardiac Magnetic Resonance Imaging X-Ray coronary angiography: X-Ray coronary angiography Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test . |
| BG001 | SPECT-guided Management | Patients to be managed according to the results of SPECT SPECT: SPECT: Single Photon Emission Computed Tomography X-Ray coronary angiography: X-Ray coronary angiography Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test . |
| BG002 | 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 SPECT: SPECT: Single Photon Emission Computed Tomography CT calcium score: CT calcium score Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test . CT coronary angiography: CT coronary angiography X-Ray coronary angiography: X-Ray coronary angiography |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Unnecessary Invasive Coronary Angiography |
| Posted | Count of Participants | Participants | 12 months |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Major Adverse Cardiovascular Event (MACE) | MACE is defined as one of the following:
| Posted | Count of Participants | Participants | at 12 months |
| |||||||||||||||||||||||||||||||||||
| Secondary | Positive Angiogram (by FFR) Rate for Each Strategy. | 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) | Posted | Count of Participants | Participants | 12 months |
| |||||||||||||||||||||||||||||||||||
| Secondary | Cost Effectiveness Analysis | 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. | Not Posted | 3 years | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Health-related Quality-of-life Measures (SAQ-UK; SF12; EQ-5D) | 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:
| Not Posted | 3 years | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Complications | 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. | Not Posted | 3 years | Participants |
12 months
MACEs: cardiovascular death, myocardial infarction, unplanned coronary revascularization, and hospital admission for cardiovascular cause.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3T CMR-guided Management | Patient to be managed according to the results of 3T CMR imaging 3T CMR: 3Tesla Cardiac Magnetic Resonance Imaging X-Ray coronary angiography: X-Ray coronary angiography Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test . | 15 | 481 | 6 | 481 | ||
| EG001 | SPECT-guided Management | Patients to be managed according to the results of SPECT SPECT: SPECT: Single Photon Emission Computed Tomography X-Ray coronary angiography: X-Ray coronary angiography Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test . | 15 | 481 | 0 | 481 | ||
| EG002 | 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 SPECT: SPECT: Single Photon Emission Computed Tomography CT calcium score: CT calcium score Patients with suspected angina pectoris were eligible if they were 30 years or older, had a CHD pretest likelihood of 10% to 90%, and suitable for revascularization. Exclusion criteria included nonanginal chest pain, a normal MPS or cardiac computed tomography (CCT) result within the previous 2 years, being clinically unstable, previous myocardial infarction, previous coronary revascularization, and contraindication to any study noninvasive imaging test . CT coronary angiography: CT coronary angiography X-Ray coronary angiography: X-Ray coronary angiography | 6 | 240 | 2 | 240 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Adverse Cardiovascular Event | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Expected Test Complication | Investigations |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor John P Greenwood | University of Leeds | +44 (0)113 3925481 | j.greenwood@leeds.ac.uk |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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