Prophylactic Intra-Aortic Balloon Counterpulsation for Delayed-Presentation Anterior ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized Controlled Trial (PROACTIVE-AMI)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 504
- 试验地点
- 4
- 主要终点
- 180-day Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
PROACTIVE-AMI is a prospective, multicenter, randomized, open-label trial with blinded endpoint adjudication evaluating whether prophylactic intra-aortic balloon counterpulsation (IABP) initiated before primary percutaneous coronary intervention (PPCI) improves clinical outcomes in patients with delayed-presentation acute anterior ST-segment elevation myocardial infarction (STEMI). Eligible patients are adults aged ≥18 years who present 4 to 12 hours after symptom onset, have electrocardiographic evidence of anterior STEMI with proximal left anterior descending artery total occlusion (TIMI flow 0), and are planned for PPCI. Participants will be randomized 1:1 to pre-PPCI IABP plus standard PPCI or standard PPCI alone. The primary endpoint is 180-day major adverse cardiovascular events (MACE), defined as a composite of all-cause death, cardiogenic shock, and new or worsening heart failure. Secondary outcomes include individual MACE components, cardiac death, length of stay, NT-proBNP, left ventricular ejection fraction, and left ventricular end-diastolic volume. Safety outcomes include major bleeding, vascular complications, thrombocytopenia, and stroke.
详细描述
This is a prospective, multicenter, randomized, open-label, parallel-group, controlled clinical trial with blinded endpoint adjudication. The study is designed to evaluate whether prophylactic intra-aortic balloon counterpulsation (IABP) before primary percutaneous coronary intervention (PPCI) can improve outcomes in patients with delayed-presentation acute anterior ST-segment elevation myocardial infarction (STEMI). Eligible patients are adults aged ≥18 years with symptom onset to presentation between 4 and 12 hours, electrocardiographic evidence of anterior STEMI (≥2 mm ST elevation in contiguous anterior leads or sum ≥4 mm), and angiographically confirmed proximal left anterior descending artery occlusion with TIMI flow 0. After informed consent and coronary angiography confirming eligibility, participants are randomized in a 1:1 ratio to one of two groups: (1) prophylactic IABP before infarct-related artery opening plus standard PPCI, or (2) standard PPCI alone. In the intervention group, IABP will be inserted before PCI, operated at a 1:1 counterpulsation ratio for at least 24 hours and up to 72 hours as clinically appropriate. In the control group, prophylactic mechanical circulatory support will not be routinely used; rescue IABP may be initiated if predefined hemodynamic deterioration or complications occur. All participants receive guideline-directed medical therapy for ST-segment elevation myocardial infarction. The primary endpoint is major adverse cardiovascular events (MACE) within 180 days after randomization, defined as a composite of all-cause death, cardiogenic shock, and new or worsening heart failure. Secondary endpoints include individual components of the primary composite endpoint, cardiac death, length of hospital stay, NT-proBNP at 90 and 180 days, left ventricular ejection fraction and left ventricular end-diastolic volume at 90 and 180 days. Safety outcomes include major bleeding (BARC 3-5), vascular complications, thrombocytopenia, and stroke within 30 days. Follow-up assessments will be performed during hospitalization and at 30, 90, and 180 days after randomization. Endpoint adjudication will be performed by an independent clinical events committee blinded to treatment assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The trial is open-label for participants and treating clinicians. Primary and key secondary outcomes will be adjudicated by an independent Clinical Events Committee blinded to treatment assignment, and imaging analyses will be performed by a blinded core laboratory.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •First electrocardiogram on arrival shows ST-segment elevation ≥ 2 mm in at least two contiguous anterior leads, or sum of ST-segment elevation ≥ 4 mm in anterior leads.
- •Ischemic symptoms (chest pain, chest tightness, upper abdominal discomfort, left shoulder radiation, etc.) onset to hospital arrival between ≥ 4 hours and ≤ 12 hours, and planned for primary PCI.
- •Coronary angiography confirms the infarct-related artery is the proximal left anterior descending (LAD) (before the first septal branch or first diagonal branch) with TIMI flow grade 0 (total occlusion).
- •Patient or legal representative provides written informed consent.
排除标准
- •Established cardiogenic shock (systolic blood pressure < 90 mmHg without inotropes/vasopressors, or requiring vasopressors to maintain systolic blood pressure ≥ 90 mmHg, AND blood lactate > 2.0 mmol/L).
- •Severe heart failure: Killip class ≥ III, or requiring non-invasive/invasive positive pressure ventilation before enrollment.
- •Malignant arrhythmias, including cardiac arrest, ventricular fibrillation, ventricular flutter, pulseless ventricular tachycardia, or high-grade atrioventricular block.
- •Severe mechanical complications (e.g., free wall rupture, ventricular septal defect, acute severe mitral regurgitation).
- •Contraindications to IABP (severe peripheral vascular disease, aortic dissection, known aortic aneurysm, moderate-to-severe aortic regurgitation).
- •Prior myocardial infarction or known chronic heart failure (left ventricular ejection fraction < 50%).
- •Prior coronary artery bypass grafting (CABG).
- •Stroke within 1 month, or history of hemorrhagic stroke at any time.
- •Active gastrointestinal bleeding within 3 months, or gastrointestinal diseases with increased bleeding risk.
- •Received thrombolytic therapy for this episode.
- •Initiation of any mechanical circulatory support (IABP, Impella, ECMO) before coronary angiography.
- •Severe hepatic insufficiency (Child-Pugh C, or ALT >5×ULN with total bilirubin >3×ULN), renal insufficiency (eGFR < 15 mL/min/1.73 m² or chronic dialysis), or end-stage disease with life expectancy < 1 year.
- •Pregnancy or lactation.
- •Currently participating in another interventional trial.
研究组 & 干预措施
Prophylactic IABP + PPCI
Participants randomized to this arm will receive prophylactic intra-aortic balloon pump counterpulsation before primary percutaneous coronary intervention (PPCI), followed by standard PPCI and guideline-directed medical therapy.
干预措施: Intra-Aortic Balloon Pump (Device)
Prophylactic IABP + PPCI
Participants randomized to this arm will receive prophylactic intra-aortic balloon pump counterpulsation before primary percutaneous coronary intervention (PPCI), followed by standard PPCI and guideline-directed medical therapy.
干预措施: Primary Percutaneous Coronary Intervention (Procedure)
Standard PPCI Alone
Participants randomized to this arm will receive standard PPCI and guideline-directed medical therapy without routine prophylactic IABP. Rescue IABP may be used only if clinically indicated according to protocol.
干预措施: Primary Percutaneous Coronary Intervention (Procedure)
结局指标
主要结局
180-day Major Adverse Cardiovascular Events (MACE)
时间窗: 180 days
Composite of all-cause death, cardiogenic shock and heart failure assessed at 180 days.
次要结局
- All-cause Death(180 days)
- Cardiogenic Shock(180 days)
- Heart Failure(180 days)
- Cardiac Death(180 days)
- Length of Hospital Stay(from admission to discharge)
- NT-proBNP(90 days)
- NT-proBNP(180 days)
- Left Ventricular Ejection Fraction (LVEF)(90 days)
- Left Ventricular Ejection Fraction (LVEF)(180 days)
- Left Ventricular End-Diastolic Volume (LVEDV)(90 days)
- Left Ventricular End-Diastolic Volume (LVEDV)(180 days)