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| ID | Type | Description | Link |
|---|---|---|---|
| k2017-01-012 | Other Grant/Funding Number | Ethics Committee of Fujian Provincial Hospital |
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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)?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous Coronary Intervention (PCI) | Experimental | The main indicators for evaluating the effectiveness and safety of the experimental intervention measures. Participants will receive the new or experimental treatment as stipulated in the trial protocol. Intervention measures description: Standard percutaneous coronary intervention (PCI) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants experiencing related adverse events after percutaneous coronary intervention | 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 | From the time of enrollment (baseline) to the 7-year follow-up after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D019060 | Minimally Invasive Surgical Procedures |