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NCT07761455

Prophylactic IABP in Delayed-Presentation Anterior STEMI

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

Summary

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.

Official title: Prophylactic Intra-Aortic Balloon Counterpulsation for Delayed-Presentation Anterior ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized Controlled Trial (PROACTIVE-AMI)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

504

Start Date

2026-08-01

Completion Date

2028-07-31

Last Updated

2026-08-12

Healthy Volunteers

Conditions

Acute Anterior ST-Segment Elevation Myocardial Infarction

Interventions

DEVICE

Intra-Aortic Balloon Pump

Intra-aortic balloon counterpulsation initiated before opening the infarct-related artery and maintained according to protocol.

PROCEDURE

Primary Percutaneous Coronary Intervention

Standard primary percutaneous coronary intervention for infarct-related artery reperfusion.

Inclusion Criteria: 1. Age ≥ 18 years. 2. 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. 3. 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. 4. 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). 5. Patient or legal representative provides written informed consent. Exclusion Criteria: 1. 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). 2. Severe heart failure: Killip class ≥ III, or requiring non-invasive/invasive positive pressure ventilation before enrollment. 3. Malignant arrhythmias, including cardiac arrest, ventricular fibrillation, ventricular flutter, pulseless ventricular tachycardia, or high-grade atrioventricular block. 4. Severe mechanical complications (e.g., free wall rupture, ventricular septal defect, acute severe mitral regurgitation). 5. Contraindications to IABP (severe peripheral vascular disease, aortic dissection, known aortic aneurysm, moderate-to-severe aortic regurgitation). 6. Prior myocardial infarction or known chronic heart failure (left ventricular ejection fraction \< 50%). 7. Prior coronary artery bypass grafting (CABG). 8. Stroke within 1 month, or history of hemorrhagic stroke at any time. 9. Active gastrointestinal bleeding within 3 months, or gastrointestinal diseases with increased bleeding risk. 10. Received thrombolytic therapy for this episode. 11. Initiation of any mechanical circulatory support (IABP, Impella, ECMO) before coronary angiography. 12. 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. 13. Pregnancy or lactation. 14. Currently participating in another interventional trial.

Locations (4)

Qilu Hospital of Shandong University, Jinan, Shandong, China

Jinan, Shandong, China

Jining No.1 People's Hospital

Jining, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China