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| Name | Class |
|---|---|
| Jinhua Central Hospital | OTHER |
| Changxing People's Hospital | OTHER |
| The Affiliated Hospital of Hangzhou Normal University | OTHER |
| Second Affiliated Hospital of Shantou University Medical College |
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Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Angiography Follow-up (RAF) group | Experimental | Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization. |
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| Routine Clinical Follow-up (RCF) group | Active Comparator | Patients in the RCF group will have routine clinical follow-up at 12 months after revascularization, and the physician will decide whether further invasive testing is needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine Angiography Follow-up | Diagnostic Test | Patients in the RAF group will have routine angiography follow-up at 12 months after revascularization. |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina | The rate of a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina | The rate of a composite endpoint of all-cause death, myocardial infarction, or hospitalization for unstable angina | 60 months |
| All-cause death |
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Inclusion Criteria:
A. Left main lesion; B. Bifurcation lesion (true bifurcation); C. Ostial lesion of main vessels (left anterior descending, left circumflex artery, right coronary artery); D. Chronic total occlusion; E. Multivessel revascularization (≥ 2 vessels); F. In-stent restenosis; G. Diffuse long lesion (lesion length ≥ 30 mm or stent length ≥ 38 mm); H. Severe calcified lesion (Significant severe calcification on angiography); I. Bypass graft lesion; J. Diabetes mellitus; K. Chronic kidney disease (defined as an estimated glomerular filtration rate of <30 ml per minute per 1.73 m2 of body-surface area or the receipt of dialysis); L. Myocardial infarction;
- He/she or his/her legally authorized representative provides written informed
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Jiang, MD, PhD | Contact | +86 0571 87784808 | jiang-jun@zju.edu.cn | |
| Jinlong Zhang, MD, PhD | Contact | +86 15757197513 | jinlong1102@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Dongyang People's Hospital | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Huizhou Municipal Central Hospital | OTHER |
| First Affiliated Hospital of Ningbo University | NETWORK |
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| Routine Clinical Follow-up | Diagnostic Test | Patients in the RCF group will have routine clinical follow-up at 12 months after revascularization, and the physician will decide whether further invasive testing is needed. |
|
The rate of all-cause death
| 24 and 60 months |
| Myocardial infarction | The rate of myocardial infarction | 24 and 60 months |
| Hospitalization for unstable angina | The rate of hospitalization for unstable angina | 24 and 60 months |
| Cardiac death | The rate of hospitalization for cardiac death | 24 and 60 months |
| Invasive angiography during follow-up | The rate of invasive angiography during follow-up | 24 and 60 months |
| Any revascularization | The rate of any revascularization during follow-up (ischemia-driven vs. all-cause) | 24 and 60 months |
| Revascularization of any target vessel/lesion | The rate of revascularization of any target vessel/lesion | 24 and 60 months |
| Revascularization of any non-target vessel/lesion | The rate of revascularization of any non-target vessel/lesion | 24 and 60 months |
| Health Economics Analysis (cost-effectiveness) | 24 and 60 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |