Myocardial Infarction
Conditions
Brief summary
Research Objectives: This clinical trial aims to evaluate the efficacy and safety of percutaneous coronary intervention (PCI) in patients with myocardial infarction (MI). The primary objective is to determine whether this approach can reduce the incidence of major adverse cardiovascular events (MACE) compared to current conservative treatment. Research Questions: This study aims to address the following key questions: Does standard PCI improve the clinical outcomes of MI patients (such as cardiovascular death, recurrent myocardial infarction, or revascularization due to ischemia-driven vascular reconstruction)? How safe is PCI, especially in terms of bleeding risk, surgical-related complications, or other adverse events? Does PCI have a significant impact on specific secondary endpoints (such as stent thrombosis, hospitalization for heart failure, or quality of life indicators)?
Interventions
PROCEDUREPercutaneous Coronary Intervention
The culprit vessels for this surgery: LAD, LCX, RCA, LM Number of stents implanted Total number of diseased vessels Postoperative medication use Preoperative TIMI grade of the culprit vessels, postoperative TIMI grade of the culprit vessels TIMI thrombus burden classification High thrombus burden Thrombus size Thrombus aspiration No reflow/slow blood flow Imaging assessment: baseline ejection fraction, left ventricular end-diastolic diameter, left ventricular end-systolic diameter EF values at follow-up, left ventricular end-diastolic diameter, left ventricular end-systolic diameter at follow-up Follow-up dates for cardiac ultrasound Follow-up dates for cardiac magnetic resonance imaging
Sponsors
Kaiyang Lin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Inclusion Criteria: 1. Clinical diagnosis of acute myocardial infarction. 2. Successful direct or emergency PCI of the infarct-related artery. 3. Ability to undergo randomization post-PCI. 4. Ability to understand and voluntarily sign the informed consent form. 2.
Exclusion criteria
1. PCI failure (final TIMI flow \< grade 2) or presence of untreated severe stenosis. 2. Planned staged PCI or other cardiac surgery within 3 months. 3. Cardiogenic shock (Killip class IV), severe structural heart disease, or contraindications to PCI trial intervention. 4. Active bleeding or high bleeding risk. 5. Known allergy to the trial drug or its components. 6. ALT/AST \> 3x upper limit of normal (ULN); eGFR \< 30 mL/min/1.73 m². 7. Non-cardiovascular disease with life expectancy \< 1 year (e.g., active malignancy). 8. History of hemorrhagic stroke, or any ischemic stroke/transient ischemic attack within the past 6 months. 9. Requirement for long-term oral anticoagulation therapy. 10. Pregnancy, lactation, or women of childbearing potential not using effective contraception. 11. Current participation in another interventional clinical trial. 12. Any condition that may affect trial compliance, safety assessment, or result interpretation per investigator judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of participants experiencing related adverse events after percutaneous coronary intervention | From the time of enrollment (baseline) to the 7-year follow-up after the surgery | Baseline data: Age, gender, height, weight, body mass index, systolic blood pressure at admission, diastolic blood pressure at admission, heart rate, smoking history, past medical history Hospital Admission Situation Perioperative period: The diseased blood vessels, number of stent implants, and biochemical indicators of this surgery; Primary outcome indicators: During hospitalization, the number of related adverse events that occurred in patients around the 7th day after surgery - hematoma at the puncture site, contrast-induced nephropathy, coronary artery dissection, stent thrombosis, etc. Hospitalization events: GRACE score, death during hospitalization Continuous follow-up until the last patient was enrolled (from June 2, 2017 to October 23, 2024): All-cause death, MACE1, stroke, recurrent myocardial infarction, stent restenosis, percutaneous coronary intervention, unplanned vascular reconstruction |
Outcome results
None listed