Danish Cardiogenic Shock Trial

Not Applicable

Completed

• Conditions: Cardiogenic Shock Acute; Acute Myocardial Infarction
• Interventions: Device: Conventional circulatory support; Device: Impella CP

• Registration Number: NCT01633502
• Lead Sponsor: Odense University Hospital

Brief Summary

Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite rapid invasive treatment, circulatory support using positive inotropes and mechanical support with intra-aortic balloon counterpulsation (IABP), and evaluation of several new treatments during the last decade, the mortality in patients with cardiogenic shock still exceeds 50%. An alternative to current management is restoration of the volume of blood pumped by the heart (cardiac output) using a ventricular assist device. In the acute setting this is difficult but can be done using the Impella device which is a catheter-based, axial flow pump that pumps blood directly from the left ventricle into the circulation thereby restoring blood flow to the failing organs. In 2012 a more powerful Impella has been introduced that is able to deliver 3.5l/min (approximately 75% of a normal cardiac output). The hypothesis of the current study is to reduce mortality and morbidity of patients with cardiogenic shock using the Impella CP. The study will be carried out as a randomized multicenter study where eligible patients will be randomized to receive conventional circulatory support or support with the Impella device and inotropic support if needed. A total of 360 patients are planned to be enrolled, and the primary endpoint will be death.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-06-29
• Study First Posted: 2012-07-04
• Study Start: 2012-12
• Primary Completion: 2023-07
• Study Completion: 2024-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. ST segment elevation myocardial infarction of less than 36 hours' duration, confirmed by new onset ST-segment elevation, or emergency angiography demonstrating acute occlusion of coronary artery, and

2. Cardiogenic shock of less than 24 hours' duration, confirmed by:

   • peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5mmol/l and/or SvO2 <55% with a normal PaO2) and
   • systolic blood pressure less than 100mmHg and/or need for vasopressor therapy (dopamine/ norepinephrine or epinephrine), and

3. Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index >1,6.

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Exclusion Criteria

1. Other causes of shock (hypovolemia, hemorrhage, sepsis, pulmonary embolism or anaphylaxis).
2. Shock due to mechanical complication to myocardial infarction (papillary muscle rupture, rupture of the ventricular septum or rupture of free wall).
3. Severe aorta valve regurgitation/stenosis.
4. Predominant right ventricular failure.
5. Out of hospital cardiac arrest with persistent Glasgow coma scale <8 after return of spontaneous circulation.
6. Shock duration>24 hours.
7. Known heparin intolerance.
8. Already established mechanical circulatory support
9. Do not resuscitate wish.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional circulatory support	Conventional circulatory support	Patients randomized to conventional circulatory support.
Impella	Impella CP	Patients randomized to Impella CP

Primary Outcome Measures

Name	Time	Method
Death	up to 6 months	Death from all causes

Secondary Outcome Measures

Name	Time	Method
MACE	minimum follow-up 6 months	Major cardiovascular events, death, cardiac transplant, escalation to permanent left ventricular assist device, re-hospitalization for heart failure.
Composite saftey	up to 6 months	Combined safety comprising major bleeding, vascular complications, and significant hemolysis.
Days alive out of hospital	up tp 6 months	Days alive and out of hospital; calculated by subtracting the number of days spent in hospital, from time of randomization to end of follow-up (180 days) for each patient.

Trial Locations

Locations (13)

University Hospital Bonn; 🇩🇪 Bonn, Germany

Dresden University Hospital; 🇩🇪 Dresden, Germany

Düsseldorf University Hospital; 🇩🇪 Düsseldorf, Germany

UKE Hamburg; 🇩🇪 Hamburg, Germany

Hannover Medical School; 🇩🇪 Hannover, Germany

Jena University Hospital; 🇩🇪 Jena, Germany

University Hospital Würzburg; 🇩🇪 Würzburg, Germany

Brüderkrankenhaus Trier; 🇩🇪 Trier, Germany

NHs Harefield Hospital; 🇬🇧 London, United Kingdom

Charite Berlin; 🇩🇪 Berlin, Germany

Copenhagen University Hospital Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Aarhus University Hospital Skejby; 🇩🇰 Aarhus, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark