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Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support (RISE)

2026年8月24日 更新者：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

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (推定)

115

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • ドイツ
      • Cologne、ドイツ、50937
        • 募集
        • University Hospital Cologne
        • コンタクト：
    • North Rhine-Westphalia
      • Düsseldorf、North Rhine-Westphalia、ドイツ、40225
    • Schleswig-Holstein
      • Kiel、Schleswig-Holstein、ドイツ、24105
        • 募集
        • University Hospital Schleswig-Holstein, Campus Kiel
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

Inclusion Criteria:

  1. Age ≥18 years and ≤77 years
  2. Patients with ACS-CS (STEMI and NSTEMI with a culprit lesion that received revascularisation) and Impella CP™ support during initial revascularisation

  3. The following additional parameters must be met at the time of initial revascularisation procedure:

    1. Hypotension or need for inotropes AND
    2. Lactate > 2.5 mM AND
    3. Left ventricular ejection fraction (EF) < 45%

  4. Need for escalation to Impella 5.5 at the discretion of the treating physician and the following criteria are fulfilled:

    1. Decision for Impella 5.5 escalation within 6 ± 1 hours after completion of initial revascularisation procedure
    2. Escalation to Impella 5.5procedure is initiated within 24 hours after completion of the initial revascularisation procedure
  5. 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
  6. Prospective Informed Consent obtained from the patient or deferred consent according to "Cologne Model" applied.

Exclusion Criteria:

  1. 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.
  2. Elevated risk of hypoxic brain injury indicated by MIRACLE2 score >3 (Aldous et al., 2023)
  3. Platelet count <75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwillingness to receive blood transfusions
  4. Active bleeding (e.g. access site bleeding or GI bleeding, etc.) with need for transfusion within 6 ± 1 hours after initial revascularisation
  5. Any contraindication listed in the Impella 5.5 IFU if known to be present
  6. Chronic haemodialysis and/or chronic kidney disease stage G5 according to KDIGO
  7. Pregnancy or lactation, if known
  8. 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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Device Group
Rapid escalation to Impella 5.5
デバイス：Escalation to more capable microaxial flow-pump (Impella 5.5)
Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Vasoactive Hemodynamic Score (VHS) < 5
時間枠：48 hours post revascularization

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

二次結果の測定

結果測定
メジャーの説明
時間枠
All-cause mortality
時間枠：In-hospital or 30 days post revascularization (whatever comes first)
In-hospital or 30 days post revascularization (whatever comes first)
All-cause mortality
時間枠：180 days post revascularization
180 days post revascularization
Cardiac output
時間枠：At time of enrolment, 48 hours as well as 72 hours post revascularization.
measured by pulmonary artery catheter (PAC) [l/min]
At time of enrolment, 48 hours as well as 72 hours post revascularization.
Vasoactive-Inotropic Score (VIS)
時間枠：At time of enrolment, 48 hours as well as 72 hours post revascularization.

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.
Lactate
時間枠：At time of enrolment, 48 hours as well as 72 hours post revascularisation
Arterial lactate measured by blood gas analysis [mmol/l]
At time of enrolment, 48 hours as well as 72 hours post revascularisation
Perfusion
時間枠：At time of enrolment and 48 hours post revascularization.
Enhanced perfusion of the limb used for Impella CP™ access by comparing NIRS measurements [%]
At time of enrolment and 48 hours post revascularization.
Major Bleeding
時間枠：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.
Either according to BARC classification (BARC ≥ IIIa) or GUSTO classification (at least moderate bleeding)
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.
Ischemia of the extremities
時間枠：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.
Peripheral vascular ischemia (femoral and axillary) with indication to percutaneous intervention or surgical repair
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.
Haemolysis
時間枠：At time of enrolment, 48 hours as well as 72 hours post revascularization.
Prevalence of clinically relevant haemolysis according to SHARC definitions
At time of enrolment, 48 hours as well as 72 hours post revascularization.
Cerebral events
時間枠：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.
Cerebral ischemia or cerebral bleeding assessed via standard-of-care neurological assessment and/or imaging
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.
Acute kidney injury (AKI)
時間枠：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.
Acute kidney injury (AKIN level 2 or greater) and/or need for renal replacement therapy (RRT)
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.
Sepsis with positive blood culture
時間枠：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.
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.
Access site infection
時間枠：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.
Access site infection with the need to surgical intervention
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.
Time to extubation
時間枠：At 30 days post revascularization
Time to extubation in hours
At 30 days post revascularization
Time to ambulation
時間枠：At 30 days post revascularization
Time to ambulation in hours
At 30 days post revascularization
Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant
時間枠：At 30 days and 180 days post revascularization
Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant
At 30 days and 180 days post revascularization
Major adverse kidney events (MAKE)
時間枠：At 30 days and 180 days post revascularization
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)
At 30 days and 180 days post revascularization

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University Hospital of Cologne

協力者

Johnson & Johnson

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月23日

一次修了 (推定)

2028年10月1日

研究の完了 (推定)

2028年10月1日

試験登録日

最初に提出

2026年4月21日

QC基準を満たした最初の提出物

2026年6月15日

最初の投稿 (実際)

2026年6月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月27日

QC基準を満たした最後の更新が送信されました

2026年8月24日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 25-1387
  • HORIZON-JU-IHI-2025-09 (その他の助成金/資金番号：IHI Joint Undertaking)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Due to data protection regulations and study contracts

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

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