Trial Outcomes & Findings for Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease-2 (NCT NCT01664858)
NCT ID: NCT01664858
Last Updated: 2018-11-23
Results Overview
* 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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1202 participants
Primary outcome timeframe
12 months
Results posted on
2018-11-23
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
481
|
481
|
240
|
|
Overall Study
COMPLETED
|
467
|
468
|
234
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease-2
Baseline characteristics by cohort
| Measure |
3T CMR-guided Management
n=481 Participants
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 .
|
SPECT-guided Management
n=481 Participants
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 .
|
NICE-guidelines Based Management
n=240 Participants
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
n=1202 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 9.10 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 8.87 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 9.21 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 9.03 • n=4 Participants
|
|
Sex: Female, Male
Female
|
227 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
564 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
254 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
638 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
3T CMR-guided Management
n=481 Participants
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 .
|
SPECT-guided Management
n=481 Participants
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 .
|
NICE-guidelines Based Management
n=240 Participants
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
|
|---|---|---|---|
|
Number of Participants With Unnecessary Invasive Coronary Angiography
|
36 Participants
|
34 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: at 12 monthsMACE 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.
Outcome measures
| Measure |
3T CMR-guided Management
n=481 Participants
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 .
|
SPECT-guided Management
n=481 Participants
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 .
|
NICE-guidelines Based Management
n=240 Participants
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
|
|---|---|---|---|
|
Major Adverse Cardiovascular Event (MACE)
|
20 Participants
|
17 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 monthsThe 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)
Outcome measures
| Measure |
3T CMR-guided Management
n=481 Participants
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 .
|
SPECT-guided Management
n=481 Participants
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 .
|
NICE-guidelines Based Management
n=240 Participants
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
|
|---|---|---|---|
|
Positive Angiogram (by FFR) Rate for Each Strategy.
|
47 Participants
|
42 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 3 yearsTo 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsHealth-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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsComplications - 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.
Outcome measures
Outcome data not reported
Adverse Events
3T CMR-guided Management
Serious events: 15 serious events
Other events: 6 other events
Deaths: 0 deaths
SPECT-guided Management
Serious events: 15 serious events
Other events: 0 other events
Deaths: 0 deaths
NICE-guidelines Based Management
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3T CMR-guided Management
n=481 participants at risk
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 .
|
SPECT-guided Management
n=481 participants at risk
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 .
|
NICE-guidelines Based Management
n=240 participants at risk
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
|
|---|---|---|---|
|
Cardiac disorders
Major Adverse Cardiovascular Event
|
3.1%
15/481 • Number of events 20 • 12 months
MACEs: cardiovascular death, myocardial infarction, unplanned coronary revascularization, and hospital admission for cardiovascular cause.
|
3.1%
15/481 • Number of events 17 • 12 months
MACEs: cardiovascular death, myocardial infarction, unplanned coronary revascularization, and hospital admission for cardiovascular cause.
|
2.5%
6/240 • Number of events 7 • 12 months
MACEs: cardiovascular death, myocardial infarction, unplanned coronary revascularization, and hospital admission for cardiovascular cause.
|
Other adverse events
| Measure |
3T CMR-guided Management
n=481 participants at risk
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 .
|
SPECT-guided Management
n=481 participants at risk
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 .
|
NICE-guidelines Based Management
n=240 participants at risk
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
|
|---|---|---|---|
|
Investigations
Expected Test Complication
|
1.2%
6/481 • Number of events 6 • 12 months
MACEs: cardiovascular death, myocardial infarction, unplanned coronary revascularization, and hospital admission for cardiovascular cause.
|
0.00%
0/481 • 12 months
MACEs: cardiovascular death, myocardial infarction, unplanned coronary revascularization, and hospital admission for cardiovascular cause.
|
0.83%
2/240 • Number of events 2 • 12 months
MACEs: cardiovascular death, myocardial infarction, unplanned coronary revascularization, and hospital admission for cardiovascular cause.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place