NCT01633502

Danish Cardiogenic Shock Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiogenic Shock Acute
• Acute Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Conventional circulatory support	Control group treated with conventional circulatory support and observed in intensive care unit for a minimum of 48 hrs.
DEVICE	Impella CP	Control group treated with Impella CP for a minimum of 48 hrs.

Timeline

• Start date: 2012-12-01
• Primary completion: 2023-07-01
• Completion: 2024-04-01
• First posted: 2012-07-04
• Last updated: 2024-05-14

Locations

13 sites across 3 countries: Denmark, Germany, United Kingdom