Percutaneous Coronary Intervention for Myocardial Infarction at Fujian Provincial Hospital

NCT07405788 | Active Not Recruiting

• 1 other identifier: k2017-01-012
• Study Type: interventional
• Target: 1,344
• Locations: 0 countries
• Sites: N/A

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)?

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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)

Procedure: Percutaneous Coronary Intervention

Interventions

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

Percutaneous Coronary Intervention (PCI)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of acute myocardial infarction.
• Successful direct or emergency PCI of the infarct-related artery.
• Ability to undergo randomization post-PCI.
• Ability to understand and voluntarily sign the informed consent form.

You may not qualify if:

• PCI failure (final TIMI flow \< grade 2) or presence of untreated severe stenosis.
• Planned staged PCI or other cardiac surgery within 3 months.
• Cardiogenic shock (Killip class IV), severe structural heart disease, or contraindications to PCI trial intervention.
• Active bleeding or high bleeding risk.
• Known allergy to the trial drug or its components.
• ALT/AST \> 3x upper limit of normal (ULN); eGFR \< 30 mL/min/1.73 m².
• Non-cardiovascular disease with life expectancy \< 1 year (e.g., active malignancy).
• History of hemorrhagic stroke, or any ischemic stroke/transient ischemic attack within the past 6 months.
• Requirement for long-term oral anticoagulation therapy.
• Pregnancy, lactation, or women of childbearing potential not using effective contraception.
• Current participation in another interventional clinical trial.
• Any condition that may affect trial compliance, safety assessment, or result interpretation per investigator judgment.

Sponsors & Collaborators

• Kaiyang Lin: lead

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: February 12, 2026
• Study Start: January 1, 2017
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02