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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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SPECT is currently the dominant clinical test for diagnostic and prognostic purposes as well as therapeutic decision-making. Given the shortage of nuclear reactor-produced Tc, advancing the use of non-isotope based imaging modalities has the potential to change the standard of care for patients with CAD as each one of these technics (CMR, CT, Stress echocardiography) has its own distinct potential advantages over SPECT.
Obtain a better understanding of the clinical utility of advanced non-isotope-based imaging modalities to detect relevant CAD as potential alternatives to SPECT. Approximately 450 subjects will be enrolled in total. Three groups of about 150 patients per group. Each group will undergo imaging with 2 modalities; Group 1: 99mTcSPECT plus CMR, Group 2: 99mTcSPECT plus CT, Group 3:99mTcSPECT plus stress echocardiography. All 450 patients will undergo standard invasive coronary angiography following completion of non-invasive imaging, except for patients in whom both nuclear and non-nuclear imaging modalities reveal a normal result confirming the absence of significant coronary artery disease (i.e invasive angiography would not be clinically indicated and FFR would be considered to be above 0.8). Thrombolysis in Myocardial Infraction (TIMI) flow will be measured in all patients undergoing angiography, and fractional flow reserve (FFR) will be measured in all patients except those with TIMI flow =0, 1 and 2. All imaging procedures must be completed within 6 weeks. All patients will have a follow-up visit at 6 months after enrollment. During the 6 month follow-up visit major adverse cardiovascular events will be collected and adjudicated by a clinical endpoint committee (CEC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnosis | Group 3: 99mTCSPECT plus stress echocardiography | ||
| group 1 : diagnosis | Group 1: 99mTcSPECT plus CMR | ||
| Group 2: diagnosis | Group 2: 99mTcSPECT plus CT |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality | The overall accuracy is calculated as the probability that a subject is correctly classified (presence of significant CAD or not) by non-invasive imaging modality. The standard of truth is presence of significant CAD or not according to the invasive fractional flow reserve (FFR) | baseline |
| Sensitivity of "significant CAD" according to non-invasive imaging modality | The sensitivity is calculated as the probability that a subject with presence of significant CAD according to FFR is correctly identified as such by non-invasive imaging modality | baseline |
| Specificity of "significant CAD" according to non-invasive imaging modality | The specificity is calculated as the probability that a subject with absence of significant CAD according to FFR is correctly identified as such by non-invasive imaging modality | baseline |
| Positive predictive value of "significant CAD" according to non-invasive imaging modality | The positive predictive value is calculated as the probability that a subject with presence of significant CAD according to non-invasive imaging modality truly have significant CAD according to FFR | baseline |
| Negative predictive value of "significant CAD" according to non-invasive imaging modality | The negative predictive value is calculated as the probability that a subject with absence of significant CAD according to non-invasive imaging modality truly does not have significant CAD according to FFR | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR | baseline | |
| Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of "high-risk CAD" according to non-invasive imaging modality flow and FFR | baseline | |
| Positive predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR | baseline |
Inclusion Criteria:
Exclusion Criteria:
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Approximately 450 patients across Canada. Patients will be identified after a clinically indicated SPECT for evaluation of myocardial ischemia.The investigator will assign the patient in one of the three groups based on his medical assessment and availability of equipment at the centre.
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Claude Tardif, M.D | Montreal Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Institute | Montreal | Quebec | Canada |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Negative predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR | baseline |
| Overall accuracy of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE) | baseline |
| Sensitivity of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE) | baseline |
| Specificity of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE) | baseline |
| Positive predictive value of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE) | baseline |
| Negative predictive value of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE) | baseline |