Prophylactic IABP in Delayed-Presentation Anterior STEMI (PROACTIVE-AMI)
2026년 8월 10일 업데이트: Qilu Hospital of Shandong University
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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
504
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Chuanbao Li, MD
- 전화번호: +86 18560083097
- 이메일: lichuanbao@qiluhospital.cn
연구 연락처 백업
- 이름: Yuguo Chen, MD
- 전화번호: +86 18560085555
- 이메일: chen919085@126.com
연구 장소
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Beijing, 중국, 100037
- Fuwai Hospital, Chinese Academy of Medical Sciences
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연락하다:
- Qing Gu, MD, PhD
- 전화번호: +86 10 88396009
- 이메일: guqingfw@126.com
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Shandong
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Jinan, Shandong, 중국, 250012
- Qilu Hospital of Shandong University, Jinan, Shandong, China
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연락하다:
- Yuguo Chen, MD
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연락하다:
- Chuanbao Li, MD
- 전화번호: +86 18560083097
- 이메일: bao2460@126.com
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Jining, Shandong, 중국, 272011
- Jining No.1 People's Hospital
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연락하다:
- Daqing Song, MD
- 전화번호: +86 537 2253115
- 이메일: songdq_jn@163.com
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Qingdao, Shandong, 중국, 266003
- The Affiliated Hospital of Qingdao University
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연락하다:
- Peng Li, MD
- 전화번호: +86 532 82911101
- 이메일: lipeng_qdu@163.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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Intra-aortic balloon counterpulsation initiated before opening the infarct-related artery and maintained according to protocol.
Standard primary percutaneous coronary intervention for infarct-related artery reperfusion.
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활성 비교기: 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.
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Standard primary percutaneous coronary intervention for infarct-related artery reperfusion.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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180-day Major Adverse Cardiovascular Events (MACE)
기간: 180 days
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Composite of all-cause death, cardiogenic shock and heart failure assessed at 180 days.
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180 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
All-cause Death
기간: 180 days
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Death from any cause assessed at 180 days.
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180 days
|
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Cardiogenic Shock
기간: 180 days
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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.
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180 days
|
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Heart Failure
기간: 180 days
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New-onset or worsening heart failure during hospitalization or rehospitalization after discharge for heart failure, assessed at 180 days.
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180 days
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Cardiac Death
기간: 180 days
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Death due to cardiovascular causes assessed at 180 days.
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180 days
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Length of Hospital Stay
기간: from admission to discharge
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Number of days from admission to discharge.
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from admission to discharge
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NT-proBNP
기간: 90 days
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Plasma NT-proBNP level at 90 days.
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90 days
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NT-proBNP
기간: 180 days
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Plasma NT-proBNP level at 180 days.
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180 days
|
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Left Ventricular Ejection Fraction (LVEF)
기간: 90 days
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Left ventricular ejection fraction assessed by echocardiography or other protocol-specified imaging modality at 90 days.
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90 days
|
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Left Ventricular Ejection Fraction (LVEF)
기간: 180 days
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Left ventricular ejection fraction assessed by echocardiography or other protocol-specified imaging modality at 180 days.
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180 days
|
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Left Ventricular End-Diastolic Volume (LVEDV)
기간: 90 days
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Left ventricular end-diastolic volume assessed by echocardiography or other protocol-specified imaging modality at 90 days.
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90 days
|
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Left Ventricular End-Diastolic Volume (LVEDV)
기간: 180 days
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Left ventricular end-diastolic volume assessed by echocardiography or other protocol-specified imaging modality at 180 days.
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180 days
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Major Bleeding
기간: 30 days
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Safety Outcome Measures: Bleeding events classified as BARC 3-5, assessed at 30 days.
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30 days
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Vascular Complications
기간: 30 days
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Safety Outcome Measures: Severe vascular complications requiring surgical or endovascular repair, including limb ischemia, pseudoaneurysm, or arterial dissection, assessed at 30 days.
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30 days
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Thrombocytopenia
기간: 30 days
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Safety Outcome Measures: Platelet count <100 × 10^9/L or a decrease of >50% from baseline, assessed at 30 days.
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30 days
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Stroke
기간: 30 days
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Safety Outcome Measures: Ischemic or hemorrhagic stroke adjudicated by the Clinical Events Committee, assessed at 30 days.
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30 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Yuguo Chen, Qilu Hospital of Shandong University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2028년 1월 31일
연구 완료 (추정된)
2028년 7월 31일
연구 등록 날짜
최초 제출
2026년 8월 1일
QC 기준을 충족하는 최초 제출
2026년 8월 10일
처음 게시됨 (실제)
2026년 8월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 10일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KYLL-2026-04-009-2
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .