Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support (RISE)
2026년 8월 24일 업데이트: Stephan Baldus, University Hospital of Cologne
Rapid Impella Support and Escalation Trial
The aim of this trial is to evaluate whether a structured and time-optimized escalation strategy from a transfemoral microaxial flow-pump (Impella CP™) to the Impella 5.5™ microaxial flow-pump is associated with improved clinical outcomes and fewer adverse events in patients with cardiogenic shock due to acute myocardial infarction
연구 개요
상세 설명
By examining best-practice MCS management and the role of early escalation to Impella 5.5™ in clinical routine care for high-risk patients with deteriorating shock, the study seeks to investigate current treatment strategies that ensure the most appropriate device selection and support intensity at the earliest clinically meaningful time point.
This observational approach aims to advance the optimal management of ACS-CS while addressing the complications reported in the DanGer Shock trial.
연구 유형
관찰
등록 (추정된)
115
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Sebastian Heyne, Dr. med.
- 전화번호: +4915125364083
- 이메일: sebastian.heyne@uk-koeln.de
연구 장소
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Cologne, 독일, 50937
- 모병
- University Hospital Cologne
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연락하다:
- Sebastian Heyne, Dr. med.
- 전화번호: +49 221 478 84452
- 이메일: sebastian.heyne@uk-koeln.de
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, 독일, 40225
- 모병
- University Hospital Düsseldorf
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연락하다:
- Malte Kelm, Prof.
- 전화번호: +49 211 8118801
- 이메일: kardiologie@med.uni-duesseldorf.de
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, 독일, 24105
- 모병
- University Hospital Schleswig-Holstein, Campus Kiel
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연락하다:
- Bernd Panholzer, Dr.med.
- 전화번호: +49 431 50028193
- 이메일: Bernd.Panholzer@uksh.de
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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
샘플링 방법
비확률 샘플
연구 인구
Patients with ACS-CS (STEMI or NSTEMI) who undergo Impella CP™-supported revascularisation of the culprit lesion and are considered for escalation to Impella 5.5 at the discretion of the treating investigator will be assessed for eligibility to participate in this observational study.
설명
Inclusion Criteria:
- Age ≥18 years and ≤77 years
- Patients with ACS-CS (STEMI and NSTEMI with a culprit lesion that received revascularisation) and Impella CP™ support during initial revascularisation
The following additional parameters must be met at the time of initial revascularisation procedure:
- Hypotension or need for inotropes AND
- Lactate > 2.5 mM AND
- Left ventricular ejection fraction (EF) < 45%
Need for escalation to Impella 5.5 at the discretion of the treating physician and the following criteria are fulfilled:
- Decision for Impella 5.5 escalation within 6 ± 1 hours after completion of initial revascularisation procedure
- Escalation to Impella 5.5procedure is initiated within 24 hours after completion of the initial revascularisation procedure
- Need for inotropes and/or vasopressors with VIS > 5 but ≤ 50 at Impella CP™ support at level P7 or above at 6+1 hours after completion of initial revascularisation procedure
- Prospective Informed Consent obtained from the patient or deferred consent according to "Cologne Model" applied.
Exclusion Criteria:
- Implanted VA-ECMOwithin 6 ± 1 hours after initial revascularisation Note: If VA-ECMO support is needed between 6 ± 1 hours after initial revascularisation and escalation to Impella 5.5, patients will be included forlimited data collection per Table 2 only. In this case the same Informed Consent Process as for regular trial participants applies.
- Elevated risk of hypoxic brain injury indicated by MIRACLE2 score >3 (Aldous et al., 2023)
- Platelet count <75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwillingness to receive blood transfusions
- Active bleeding (e.g. access site bleeding or GI bleeding, etc.) with need for transfusion within 6 ± 1 hours after initial revascularisation
- Any contraindication listed in the Impella 5.5 IFU if known to be present
- Chronic haemodialysis and/or chronic kidney disease stage G5 according to KDIGO
- Pregnancy or lactation, if known
- Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint, if known
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Device Group
Rapid escalation to Impella 5.5
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Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Vasoactive Hemodynamic Score (VHS) < 5
기간: 48 hours post revascularization
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Vasoactive Hemodynamic Score = Hemodynamic Score (HS) x Vasoactive-Inotropic Score (VIS) Higher VHS indicates more severe hemodynamic compromise relative to degree of pharmacological circulatory support. Range: Minimum 1, Maximum 110 Hemodynamic Score: HS = Points are allocated for measured heart rate, mean arterial blood pressure and arterial lactate (minimum 1, maximum 11) Vasoactive-Inotropic Score: Points are allocated for every 10 increment according to the following formula: Dopamine dose (μg/kg/min) + Dobutamine dose (μg/kg/min) + 100 x Epinephrine dose (μg/kg/min) + 10 x Milrinone (μg/kg/min) + 100 x Norepinephrine dose (μg/kg/min) + 50 x Levosimendan dose (μg/kg/min) |
48 hours post revascularization
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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All-cause mortality
기간: In-hospital or 30 days post revascularization (whatever comes first)
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In-hospital or 30 days post revascularization (whatever comes first)
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All-cause mortality
기간: 180 days post revascularization
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180 days post revascularization
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Cardiac output
기간: At time of enrolment, 48 hours as well as 72 hours post revascularization.
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measured by pulmonary artery catheter (PAC) [l/min]
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At time of enrolment, 48 hours as well as 72 hours post revascularization.
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Vasoactive-Inotropic Score (VIS)
기간: At time of enrolment, 48 hours as well as 72 hours post revascularization.
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Vasoactive-Inotropic Score (VIS): A composite measure of vasoactive and inotropic medication support. Scores range from 0 to no fixed maximum, with higher scores indicating greater vasoactive/inotropic support requirements and therefore a worse clinical status and prognosis. VIS=dopamine + dobutamine + 100×epinephrine + 10×milrinone + 10,000×vasopressin + 100×norepinephrine (all doses in μg/kg/min except vasopressin in U/kg/min) |
At time of enrolment, 48 hours as well as 72 hours post revascularization.
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Lactate
기간: At time of enrolment, 48 hours as well as 72 hours post revascularisation
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Arterial lactate measured by blood gas analysis [mmol/l]
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At time of enrolment, 48 hours as well as 72 hours post revascularisation
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Perfusion
기간: At time of enrolment and 48 hours post revascularization.
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Enhanced perfusion of the limb used for Impella CP™ access by comparing NIRS measurements [%]
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At time of enrolment and 48 hours post revascularization.
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Major Bleeding
기간: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) until the first documented bleeding event.
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Either according to BARC classification (BARC ≥ IIIa) or GUSTO classification (at least moderate bleeding)
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During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) until the first documented bleeding event.
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Ischemia of the extremities
기간: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) at the timepoint of intervention/surgery assessed up to 30 days.
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Peripheral vascular ischemia (femoral and axillary) with indication to percutaneous intervention or surgical repair
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During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) at the timepoint of intervention/surgery assessed up to 30 days.
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Haemolysis
기간: At time of enrolment, 48 hours as well as 72 hours post revascularization.
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Prevalence of clinically relevant haemolysis according to SHARC definitions
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At time of enrolment, 48 hours as well as 72 hours post revascularization.
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Cerebral events
기간: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) assessed up to 30 days.
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Cerebral ischemia or cerebral bleeding assessed via standard-of-care neurological assessment and/or imaging
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During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) assessed up to 30 days.
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Acute kidney injury (AKI)
기간: Every event during the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first), assessed at the timepoint of occurence up to 30 days.
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Acute kidney injury (AKIN level 2 or greater) and/or need for renal replacement therapy (RRT)
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Every event during the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first), assessed at the timepoint of occurence up to 30 days.
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Sepsis with positive blood culture
기간: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) at the timpoint of first positive blood culture up to 30 days.
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During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) at the timpoint of first positive blood culture up to 30 days.
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Access site infection
기간: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death (whichever comes first), at the timepoint of surgical intervention up to 30 days.
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Access site infection with the need to surgical intervention
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During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death (whichever comes first), at the timepoint of surgical intervention up to 30 days.
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Time to extubation
기간: At 30 days post revascularization
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Time to extubation in hours
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At 30 days post revascularization
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Time to ambulation
기간: At 30 days post revascularization
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Time to ambulation in hours
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At 30 days post revascularization
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Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant
기간: At 30 days and 180 days post revascularization
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Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant
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At 30 days and 180 days post revascularization
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Major adverse kidney events (MAKE)
기간: At 30 days and 180 days post revascularization
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Death (from any cause) or new requirement for renal replacement therapy (RRT) (e.g., dialysis) or persistent renal dysfunction (PRD) (defined as a worsening of kidney function denoted by ≥ 25% decline in the estimated glomerular filtration rate (eGFR) from baseline)
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At 30 days and 180 days post revascularization
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (실제)
2026년 4월 23일
기본 완료 (추정된)
2028년 10월 1일
연구 완료 (추정된)
2028년 10월 1일
연구 등록 날짜
최초 제출
2026년 4월 21일
QC 기준을 충족하는 최초 제출
2026년 6월 15일
처음 게시됨 (실제)
2026년 6월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 24일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 25-1387
- HORIZON-JU-IHI-2025-09 (기타 보조금/기금 번호: IHI Joint Undertaking)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Due to data protection regulations and study contracts
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
예
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