Acute Myocardial Infarction (AMI), Non-ST-Segment Elevation Myocardial Infarction(NSTEMI), ST-Segment Elevation Myocardial Infarction(STEMI)
Conditions
Keywords
AMI, DES, TLF, IMR, OCT
Brief summary
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 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.
Interventions
DRUGGuideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction
PROCEDUREDES implantation plus guideline-recommended standard medical therapy
DES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
Sponsors
Harbin Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Outcomes assessor-blinded
Intervention model description
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 .
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients aged ≥18 years and ≤75 years; 2. Diagnosis of type 1 AMI, including STEMI (onset \<24 hours or 7-14 days) or NSTEMI; 3. After coronary angiography (CAG) ± thrombus aspiration, TIMI flow in the culprit vessel is restored to grade 3 and maintained for at least 5 minutes, with diameter stenosis (DS) \<70% at the culprit lesion (QCA); 4. Reference diameter of the culprit lesion \>2.5 mm and ≤4.0 mm; 5. Patients or a legally authorized representative must provide written Informed Consent prior to any study related procedure.
Exclusion criteria
1.Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure(TLF) | From randomization to the end of the study, median follow-up duration is 30 months. | TLF is defined as a composite endpoint consisting of cardiovascular death, target vessel myocardial infarction and ischemia-driven target lesion revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
| 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) | From randomization to the end of the study, median follow-up duration is 30 months. | MACCE: defined as a composite endpoint consisting of all-cause death, myocardial infarction, stroke, and repeat revascularization. |
| Seattle Angina Questionnaire(SAQ)score | From 24 hours after surgery to discharge and the 12th month after discharge | — |
Countries
China
Contacts
CONTACTJingbo Hou, Ph.D.
CONTACTBo Yu, Ph.D.
PRINCIPAL_INVESTIGATORBo Yu, Ph.D.
The Second Affiliated Hospital of Harbin Medical University
PRINCIPAL_INVESTIGATORJingbo Hou, Ph.D.
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed