Danish Cardiogenic Shock Trial

Acute Myocardial Infarction Clinical Trial

— DanShock  

Official title:

Effects of Advanced Mechanical Circulatory Support in Patients With ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock. The Danish Cardiogenic Shock Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633502
• Other study ID #: DanShock-01
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: April 2024

Study information

• Verified date: May 2024
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: April 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Cardiogenic Shock Acute
• Infarction
• Myocardial Infarction
• Shock
• Shock, Cardiogenic

Intervention

Device:
• Conventional circulatory support
Control group treated with conventional circulatory support and observed in intensive care unit for a minimum of 48 hrs.
• Impella CP
Control group treated with Impella CP for a minimum of 48 hrs.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital Skejby	Aarhus
Denmark	Copenhagen University Hospital Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense
Germany	Charite Berlin	Berlin
Germany	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	Brüderkrankenhaus Trier	Trier
Germany	University Hospital Würzburg	Würzburg
United Kingdom	NHs Harefield Hospital	London

Sponsors (12)

Lead Sponsor	Collaborator
Odense University Hospital	Aarhus University Hospital Skejby, Charite University, Berlin, Germany, Hannover Medical School, Heinrich-Heine University, Duesseldorf, Jena University Hospital, Rigshospitalet, Denmark, Royal Brompton & Harefield NHS Foundation Trust, Universitätsklinikum Hamburg-Eppendorf, University Hospital Dresden, University Hospital, Bonn, Wuerzburg University Hospital

Countries where clinical trial is conducted

Denmark,  Germany,  United Kingdom, 

References & Publications (3)

Moller JE, Engstrom T, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Werner N, Frydland M, Holmvang L, Kjaergaard J, Sorensen R, Lonborg J, Lindholm MG, Udesen NLJ, Junker A, Sc — View Citation

Moller JE, Gerke O; DanGer Shock Investigators. Danish-German cardiogenic shock trial-DanGer shock: Trial design update. Am Heart J. 2023 Jan;255:90-93. doi: 10.1016/j.ahj.2022.10.078. Epub 2022 Oct 19. — View Citation

Udesen NJ, Moller JE, Lindholm MG, Eiskjaer H, Schafer A, Werner N, Holmvang L, Terkelsen CJ, Jensen LO, Junker A, Schmidt H, Wachtell K, Thiele H, Engstrom T, Hassager C; DanGer Shock investigators. Rationale and design of DanGer shock: Danish-German cardiogenic shock trial. Am Heart J. 2019 Aug;214:60-68. doi: 10.1016/j.ahj.2019.04.019. Epub 2019 May 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemodynamics	Cardiac power index	up to 7 days
Other	Hemodynamics	Lactate clearence	up to 7 days
Other	Hemodynamics	Pulmonary artery pulsatility index	up to 7 days
Other	Health economics	Cost of treatments	up to 6 months
Other	Renal function	Development of acute kidney injury and need for dialysis	up to 30 days
Other	Bleeding	Bleeding complications during admission	up to 30 days
Other	Revascularization strategy	Syntax score ( a grading system that evaluates the complexity and prognosis of patients undergoing percutaneous coronary intervention, higher scores denotes more complex disase and higher risk)	During procedure
Other	Revascularization strategy	Additional non culprit revascularization	up to 6 months
Primary	Death	Death from all causes	up to 6 months
Secondary	MACE	Major cardiovascular events, death, cardiac transplant, escalation to permanent left ventricular assist device, re-hospitalization for heart failure.	minimum follow-up 6 months
Secondary	Composite saftey	Combined safety comprising major bleeding, vascular complications, and significant hemolysis.	up to 6 months
Secondary	Days alive out of hospital	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.	up tp 6 months