Prophylactic IABP in Delayed-Presentation Anterior STEMI (PROACTIVE-AMI)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Anterior ST-Segment Elevation Myocardial Infarction
• Intervention / Treatment: Device: Intra-Aortic Balloon Pump; Procedure: Primary Percutaneous Coronary Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 504
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chuanbao Li, MD; Phone Number: +86 18560083097; Email: lichuanbao@qiluhospital.cn
• Study Contact Backup: Name: Yuguo Chen, MD; Phone Number: +86 18560085555; Email: chen919085@126.com

Study Locations

• China
  • Beijing, China, 100037
    • Fuwai Hospital, Chinese Academy of Medical Sciences
    • Contact: Qing Gu, MD, PhD; Phone Number: +86 10 88396009; Email: guqingfw@126.com
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University, Jinan, Shandong, China
      • Contact: Yuguo Chen, MD
      • Contact: Chuanbao Li, MD; Phone Number: +86 18560083097; Email: bao2460@126.com
    • Jining, Shandong, China, 272011
      • Jining No.1 People's Hospital
      • Contact: Daqing Song, MD; Phone Number: +86 537 2253115; Email: songdq_jn@163.com
    • Qingdao, Shandong, China, 266003
      • The Affiliated Hospital of Qingdao University
      • Contact: Peng Li, MD; Phone Number: +86 532 82911101; Email: lipeng_qdu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Procedure: Primary Percutaneous Coronary Intervention; Standard primary percutaneous coronary intervention for infarct-related artery reperfusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
180-day Major Adverse Cardiovascular Events (MACE)	Composite of all-cause death, cardiogenic shock and heart failure assessed at 180 days.	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Death	Death from any cause assessed at 180 days.	180 days
Cardiogenic Shock	Cardiogenic shock defined as systolic blood pressure <90 mmHg without vasoactive support or requiring vasoactive agents to maintain blood pressure, together with blood lactate >2.0 mmol/L, assessed at 180 days.	180 days
Heart Failure	New-onset or worsening heart failure during hospitalization or rehospitalization after discharge for heart failure, assessed at 180 days.	180 days
Cardiac Death	Death due to cardiovascular causes assessed at 180 days.	180 days
Length of Hospital Stay	Number of days from admission to discharge.	from admission to discharge
NT-proBNP	Plasma NT-proBNP level at 90 days.	90 days
NT-proBNP	Plasma NT-proBNP level at 180 days.	180 days
Left Ventricular Ejection Fraction (LVEF)	Left ventricular ejection fraction assessed by echocardiography or other protocol-specified imaging modality at 90 days.	90 days
Left Ventricular Ejection Fraction (LVEF)	Left ventricular ejection fraction assessed by echocardiography or other protocol-specified imaging modality at 180 days.	180 days
Left Ventricular End-Diastolic Volume (LVEDV)	Left ventricular end-diastolic volume assessed by echocardiography or other protocol-specified imaging modality at 90 days.	90 days
Left Ventricular End-Diastolic Volume (LVEDV)	Left ventricular end-diastolic volume assessed by echocardiography or other protocol-specified imaging modality at 180 days.	180 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Bleeding	Safety Outcome Measures: Bleeding events classified as BARC 3-5, assessed at 30 days.	30 days
Vascular Complications	Safety Outcome Measures: Severe vascular complications requiring surgical or endovascular repair, including limb ischemia, pseudoaneurysm, or arterial dissection, assessed at 30 days.	30 days
Thrombocytopenia	Safety Outcome Measures: Platelet count <100 × 10^9/L or a decrease of >50% from baseline, assessed at 30 days.	30 days
Stroke	Safety Outcome Measures: Ischemic or hemorrhagic stroke adjudicated by the Clinical Events Committee, assessed at 30 days.	30 days

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Study Chair: Yuguo Chen, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: August 1, 2026
• First Submitted That Met QC Criteria: August 10, 2026
• First Posted (Actual): August 12, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: STEMI; Primary PCI; Percutaneous coronary intervention; IABP; Intra-aortic balloon pump; Mechanical circulatory support; Anterior myocardial infarction; Delayed presentation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Anterior Wall Myocardial Infarction; Surgical Procedures, Operative; Counterpulsation; Assisted Circulation; Intra-Aortic Balloon Pumping
• Other Study ID Numbers: KYLL-2026-04-009-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the study team does not currently have a data sharing plan or repository in place. De-identified participant-level data may be available from the corresponding author upon reasonable request and subject to institutional approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No