Condition: Acute Myocardial Infarction (AMI) · ST-Segment Elevation Myocardial Infarction(STEMI) · Non-ST-Segment Elevation Myocardial Infarction(NSTEMI) · Sponsor: Harbin Medical University
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 Wire™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 …
This description comes directly from the study's public registry record.
Jingbo Hou, Ph.D. · 13303609625 · jingbohou@163.com
Bo Yu, Ph.D. · yubodr@163.com
Always discuss trial participation with your own doctor first.
| The Second Affiliated Hospital of Harbin Medical University | Harbin, Heilongjiang, China | Recruiting |
| Beijing Luhe Hospital Affiliated to Capital Medical University | Beijing, China | Not Yet Recruiting |
| Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing, China | Not Yet Recruiting |
| Cangzhou Central Hospital | Cangzhou, China | Not Yet Recruiting |
| Chengde Medical College Affiliated Hospital | Chengde, China | Not Yet Recruiting |
| Sichuan Provincial People's Hospital | Chengdu, China | Not Yet Recruiting |
| The Central Hospital Affiliated to Dalian University of Technology | Dalian, China | Not Yet Recruiting |
| The First Affiliated Hospital of Dalian Medical University | Dalian, China | Not Yet Recruiting |
| The Second Affiliated Hospital of Dalian Medical University | Dalian, China | Not Yet Recruiting |
| Daqing Oilfield General Hospital | Daqing, China | Not Yet Recruiting |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin, China | Not Yet Recruiting |
| The Third Xiangya Hospital of Central South University | Hunan, China | Not Yet Recruiting |
+ 36 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07567625