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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01664858
Recruitment Status : Completed
First Posted : August 14, 2012
Results First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Collaborators:
University of Leicester
University of Glasgow
British Heart Foundation
Information provided by (Responsible Party):
Professor JP Greenwood, University of Leeds

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Coronary Heart Disease
Interventions Other: 3T CMR
Other: SPECT
Other: CT calcium score
Other: CT coronary angiography
Other: X-Ray coronary angiography
Enrollment 1202
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 3T CMR-guided Management SPECT-guided Management NICE-guidelines Based Management
Hide Arm/Group Description

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 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 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

Period Title: Overall Study
Started 481 481 240
Completed 467 468 234
Not Completed 14 13 6
Arm/Group Title 3T CMR-guided Management SPECT-guided Management NICE-guidelines Based Management Total
Hide Arm/Group Description

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 .

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 .

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

Total of all reporting groups
Overall Number of Baseline Participants 481 481 240 1202
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 481 participants 481 participants 240 participants 1202 participants
56.5  (9.10) 55.9  (8.87) 56.5  (9.21) 56.3  (9.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 481 participants 481 participants 240 participants 1202 participants
Female
227
  47.2%
225
  46.8%
112
  46.7%
564
  46.9%
Male
254
  52.8%
256
  53.2%
128
  53.3%
638
  53.1%
1.Primary Outcome
Title Number of Participants With Unnecessary Invasive Coronary Angiography
Hide Description
  • 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
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3T CMR-guided Management SPECT-guided Management NICE-guidelines Based Management
Hide Arm/Group Description:

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 .

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 .

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

Overall Number of Participants Analyzed 481 481 240
Measure Type: Count of Participants
Unit of Measure: Participants
36
   7.5%
34
   7.1%
69
  28.7%
2.Secondary Outcome
Title Major Adverse Cardiovascular Event (MACE)
Hide Description

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.
Time Frame at 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3T CMR-guided Management SPECT-guided Management NICE-guidelines Based Management
Hide Arm/Group Description:

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 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 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

Overall Number of Participants Analyzed 481 481 240
Measure Type: Count of Participants
Unit of Measure: Participants
20
   4.2%
17
   3.5%
4
   1.7%
3.Secondary Outcome
Title Positive Angiogram (by FFR) Rate for Each Strategy.
Hide Description 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)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3T CMR-guided Management SPECT-guided Management NICE-guidelines Based Management
Hide Arm/Group Description:

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 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 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

Overall Number of Participants Analyzed 481 481 240
Measure Type: Count of Participants
Unit of Measure: Participants
47
   9.8%
42
   8.7%
29
  12.1%
4.Secondary Outcome
Title Cost Effectiveness Analysis
Hide Description 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.
Time Frame 3 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Health-related Quality-of-life Measures (SAQ-UK; SF12; EQ-5D)
Hide Description

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)
Time Frame 3 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Complications
Hide Description 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.
Time Frame 3 years
Outcome Measure Data Not Reported
Time Frame 12 months
Adverse Event Reporting Description MACEs: cardiovascular death, myocardial infarction, unplanned coronary revascularization, and hospital admission for cardiovascular cause.
 
Arm/Group Title 3T CMR-guided Management SPECT-guided Management NICE-guidelines Based Management
Hide Arm/Group Description

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 .

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 .

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

All-Cause Mortality
3T CMR-guided Management SPECT-guided Management NICE-guidelines Based Management
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
3T CMR-guided Management SPECT-guided Management NICE-guidelines Based Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/481 (3.12%)      15/481 (3.12%)      6/240 (2.50%)    
Cardiac disorders       
Major Adverse Cardiovascular Event   15/481 (3.12%)  20 15/481 (3.12%)  17 6/240 (2.50%)  7
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
3T CMR-guided Management SPECT-guided Management NICE-guidelines Based Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/481 (1.25%)      0/481 (0.00%)      2/240 (0.83%)    
Investigations       
Expected Test Complication  6/481 (1.25%)  6 0/481 (0.00%)  0 2/240 (0.83%)  2
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Professor John P Greenwood
Organization: University of Leeds
Phone: +44 (0)113 3925481
Responsible Party: Professor JP Greenwood, University of Leeds
ClinicalTrials.gov Identifier: NCT01664858     History of Changes
Other Study ID Numbers: SP/12/1/29062
First Submitted: August 10, 2012
First Posted: August 14, 2012
Results First Submitted: October 27, 2016
Results First Posted: November 22, 2018
Last Update Posted: November 22, 2018