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This study is a prospective, multicenter, open-label, non-inferiority, randomized controlled trial. A total of 2,000 patients with STEMI (<24 hours or 7-14 days) or NSTEMI will be recruited from at least 20 centers in China. Eligible patients must have residual DS < 70% at the culprit lesion assessed by QCA, with optional thrombus aspiration, and TIMI flow of grade 3. Patients will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The planned enrollment period is 36 months, and all patients will be followed up for at least 12 months after randomization, with continued follow-up until the end of the study. The primary outcome is the first occurrence of TLF after randomization, defined as the composite of cardiovascular death, target vessel myocardial infarction, ischemia-driven target lesion revascularization. The study aims to verify whether guideline-recommended standard medical therapy is non-inferior to DES implantation combined with guideline-recommended standard medical therapy in AMI patients with non-severe coronary artery stenosis.
A total of 120 participants (60 in the experimental group and 60 in the control group) enrolled at the Second Affiliated Hospital of Harbin Medical University were included in the functional substudy. Using Abbott Pressure Wireâ„¢X pressure wire test functional indicators, and explore the incidence of coronary microvascular dysfunction (CMD) as assessed by the index of microcirculatory resistance (IMR) in two groups, and its impact on the rate of the composite endpoint of all-cause death and heart failure readmission occurring for the first time within 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guideline-recommended standard medical therapy alone | Experimental | Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction. |
|
| DES implantation plus guideline-recommended standard medical therapy | Active Comparator | DES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guideline-recommended standard medical therapy alone | Drug | Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure(TLF) | TLF is defined as a composite endpoint consisting of cardiovascular death, target vessel myocardial infarction and ischemia-driven target lesion revascularization. | From randomization to the end of the study, median follow-up duration is 30 months. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | From randomization to the end of the study, median follow-up duration is 30 months. | |
| Cardiovascular death | From randomization to the end of the study, median follow-up duration is 30 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Definite or probable in-stent thrombosis | Safety endpoint | From randomization to the end of the study, median follow-up duration is 30 months. |
| Contrast-induced acute kidney injury(CI-AKI) | Safety endpoint |
Inclusion Criteria:
Exclusion Criteria:
1.Clinical exclusion criteria:
2.Imaging exclusion criteria:
3.Functional sub study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingbo Hou, Ph.D. | Contact | 13303609625 | jingbohou@163.com | |
| Bo Yu, Ph.D. | Contact | yubodr@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bo Yu, Ph.D. | The Second Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Jingbo Hou, Ph.D. | The Second Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Luhe Hospital Affiliated to Capital Medical University | Beijing | China |
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This study is a prospective, multicenter, open-label, non-inferiority, randomized controlled trial. A total of 2,000 patients with STEMI (<24 hours or 7-14 days) or NSTEMI will be recruited from at least 20 centers in China. Patients will be randomly assigned in a 1:1 ratio to the experimental group or the control group .
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Outcomes assessor-blinded
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| DES implantation plus guideline-recommended standard medical therapy | Procedure | DES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction. |
|
| Myocardial infarction (MI) | From randomization to the end of the study, median follow-up duration is 30 months. |
| Target vessel myocardial infarction | From randomization to the end of the study, median follow-up duration is 30 months. |
| Coronary Revascularization | From randomization to the end of the study, median follow-up duration is 30 months. |
| Target vessel revascularization | From randomization to the end of the study, median follow-up duration is 30 months. |
| Target lesion revascularization | From randomization to the end of the study, median follow-up duration is 30 months. |
| Ischemia-driven target lesion revascularization | From randomization to the end of the study, median follow-up duration is 30 months. |
| Stroke | From randomization to the end of the study, median follow-up duration is 30 months. |
| Rehospitalization for unstable angina pectoris | From randomization to the end of the study, median follow-up duration is 30 months. |
| Rehospitalization for heart failure | From randomization to the end of the study, median follow-up duration is 30 months. |
| Major adverse cardiovascular and cerebrovascular events (MACCE) | MACCE: defined as a composite endpoint consisting of all-cause death, myocardial infarction, stroke, and repeat revascularization. | From randomization to the end of the study, median follow-up duration is 30 months. |
| Seattle Angina Questionnaire(SAQ)score | From 24 hours after surgery to discharge and the 12th month after discharge |
| From randomization to the end of the study, median follow-up duration is 30 months. |
| Procedure-related myocardial infarction | Safety endpoint | From randomization to the end of the study, median follow-up duration is 30 months. |
| Bleeding Academic Research Consortium(BARC)type 3 and type 5 bleeding | Safety endpoint | From randomization to the end of the study, median follow-up duration is 30 months. |
| Microcirculation resistance index(IMR)to assess the incidence of coronary microvascular dysfunction (CMD) | Exploratory endpoint:Functional sub research | From randomization to the end of the study, median follow-up duration is 30 months. |
| The first occurrence of all-cause death and readmission due to heart failure within 12 months. | Exploratory endpoint:Functional sub research | From randomization to the 12th month. |
| Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing | China |
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| Cangzhou Central Hospital | Cangzhou | China |
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| Chengde Medical College Affiliated Hospital | Chengde | China |
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| Sichuan Provincial People's Hospital | Chengdu | China |
| The Central Hospital Affiliated to Dalian University of Technology | Dalian | China |
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| The First Affiliated Hospital of Dalian Medical University | Dalian | China |
| The Second Affiliated Hospital of Dalian Medical University | Dalian | China |
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| Daqing Oilfield General Hospital | Daqing | China |
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| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | China |
| The Third Xiangya Hospital of Central South University | Hunan | China |
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| Central Hospital of Jiamusi City | Jiamusi | China |
| The First Affiliated Hospital of Jiamusi University | Jiamusi | China |
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| China-Japan Union Hospital of Jilin University | Jilin City | China |
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| Jilin Central Hospital | Jilin City | China |
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| The First Hospital of Jilin University | Jilin City | China |
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| Shandong Provincial Hospital | Jinan | China |
| The Affiliated Hospital of Jining Medical University | Jining | China |
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| Lanzhou University First Hospital | Lanzhou | China |
| Linyi People's Hospital | Linyi | China |
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| Mudanjiang Cardiovascular Hospital | Mudanjiang | China |
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| The First Affiliated Hospital of Nanyang Medical College | Nanyang | China |
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| The Affiliated Hospital of Qingdao University | Qingdao | China |
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| Qiqihar First Hospital | Qiqihar | China |
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| The Second Affiliated Hospital of Qiqihar Medical University | Qiqihar | China |
| The Third Affiliated Hospital of Qiqihar Medical University | Qiqihar | China |
| Liaoning Provincial People's Hospital | Shenyang | China |
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| Shengjing Hospital of China Medical University | Shenyang | China |
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| The Fourth Affiliated Hospital of China Medical University | Shenyang | China |
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| The Second Hospital of Hebei Medical University | Shijia Zhuang | China |
| Hebei Provincial People's Hospital | Shijiazhuang | China |
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| Suihua First Hospital | Suihua | China |
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| General Hospital of Taiyuan Iron and Steel (Group) Co. | Taiyuan | China |
| Shanxi Provincial Cardiovascular Hospital | Taiyuan | China |
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| General Hospital of Tianjin Medical University | Tianjin | China |
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| TEDA International Cardiovascular Hospital | Tianjin | China |
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| Tianjin Chest Hospital | Tianjin | China |
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| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
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| Wuhan Asia Heart Hospital | Wuhan | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| People's Hospital of Xinjiang Uygur Autonomous Region | Xinjiang | China |
| The First Affiliated Hospital of Xinjiang Medical University | Xinjiang | China |
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| Yantai Yuhuangding Hospital | Yantai | China |
| Fuwai Huazhong Cardiovascular Hospital | Zhengzhou | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
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| Zunyi Medical University Affiliated Hospital | Zunyi | China |
|
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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