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The overall goal of this project is to compare the non-revascularization rate of coronary angiography in patients with stable coronary artery disease (CAD) within 90 days after CT myocardial perfusion imaging (CT-MPI) or Single-Photon Emission Computed Tomography myocardial perfusion imaging (SPECT-MPI), and 1-year major adverse cardiovascular events (MACE).
Participants will be patients with proven coronary artery disease (CAD) who are scheduled randomized to undergo CT Myocardial Perfusion Imaging (CT-MPI) or Single-Photon Emission Computed Tomography myocardial perfusion imaging (SPECT-MPI) to evaluate myocardium ischemia. Those patients with positive myocardial ischemia will scheduled to undergo invasive coronary angiography (ICA), and those without myocardial ischemia will have optical medical therapy. The purpose of the study is to verify that CT-MPI guided clinical pathways are not inferior to SPECT-MPI pathways in downstream treatment decision making and safety assessment. In order to achieve this aim, the study team will compare the non-revascularization rate of ICA within 90 days after CT-MPI and SPECT-MPI. 1-year major adverse cardiovascular events (MACE) will be also compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-MPI guided without myocardial ischemia | Experimental | There was no evidence of myocardial ischemia in patients with coronary heart disease by CT-MPI |
|
| CT-MPI guided with myocardial ischemia | Experimental | There was positive evidence of myocardial ischemia in patients with coronary heart disease by CT-MPI |
|
| SPECT-MPI guided without myocardial ischemia | Active Comparator | There was no evidence of myocardial ischemia in patients with coronary heart disease by SPECT-MPI |
|
| SPECT-MPI guided with myocardial ischemia | Active Comparator | There was positive evidence of myocardial ischemia in patients with coronary heart disease by SPECT-MPI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invasive coronary angiography | Procedure | Patients with positive myocardial ischemia either in CT-MPI guided arm or SPECT-MPI guided arm will scheduled to undergo invasive coronary angiography. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of non-revascularization treatment of the two arms | The incidence of conventional angiography not leading to revascularization within 90 days after CT-MPI or SPECT-MPI. | within 90 days after CT-MPI or SPECT-MPI examination |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of major adverse cardiovascular events of the two arms | The composition of all-cause death, non-fatal myocardial infarction, stroke, revascularization, and hospital admissions for unstable angina. | One year after CT-MPI or SPECT-MPI |
| Difference in quality of Life of the two arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Gao, M.D | Contact | 86-10-88322656 | gaoyang226@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | China |
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| routine medical treatment | Other | Patients with negative myocardial ischemia either in CT-MPI guided arm or SPECT-MPI guided arm will scheduled to have routine medical therapy instead of invasive coronary angiography. |
|
The Seattle Angina Questionnaire |
| One year after CT-MPI or SPECT-MPI |
| Difference in cost of the two arms | Total clinical cost | One year after CT-MPI or SPECT-MPI |
| Difference in cumulative radiation exposure dose of the two arms | Total cumulative radiation exposure dose | Total cumulative radiation exposure dose during CT-MPI or SPECT-MPI and invasive coronary angiography within one year |
| Fuwai Central China Cardiovascular Hospital | Active, not recruiting | Zhengzhou | Henan | China |
| The First Affiliated Hosptial of Zhengzhou University | Active, not recruiting | Zhengzhou | Henan | China |
| The Second Norman Bethune Hospital of Jilin University | Active, not recruiting | Changchun | Jilin | China |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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