CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 420 enrolled
Drug / intervention
ECLS insertion +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03637205
NCT03637205N/ACompleted

Prospective Randomized Multicenter Study Comparing Extracorporeal Life Support Plus Optimal Medical Care Versus Optimal Medical Care Alone in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Revascularization

Helios Health Institute GmbH·interventional·Posted Aug 17, 2018·Updated Dec 13, 2024

In Brief

A clinical study evaluating ECLS insertion and Revascularisation and optimal medical treatment for Acute Myocardial Infarction and Cardiogenic Shock. Completed, enrolled 420 participants across 46 sites in 2 countries.

Detailed Summary

The aim of the study is to examine whether treatment with extracorporeal life support (ECLS) in addition to revascularization with percutaneous coronary intervention (PCI) or alternatively coronary artery bypass grafting (CABG) and optimal medical treatment is beneficial in comparison to no ECLS in patients with severe infarctrelated cardiogenic shock with respect to 30-day mortality

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Slovenia

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 17, 2018
Enrollment StartJun 20, 2019
Primary CompletionDec 23, 2022
Study CompletionSep 2, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.9 years ago

Interventions

ECLS insertionprocedure

After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned. ECLS insertion should be performed preferably before revascularization

Revascularisation and optimal medical treatmentother

After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.