An interventional study of ECLS insertion and Revascularisation and optimal medical treatment in Acute Myocardial Infarction and Cardiogenic Shock, sponsored by Helios Health Institute GmbH. Completed at 46 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Helios Health Institute GmbH · Not applicable, Interventional, and Treatment
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
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 420 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Helios Health Institute GmbH is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PCI (or CABG) plus medical treatment + ECLS
Procedure: ECLS insertion · Other: Revascularisation and optimal medical treatment
PCI (or CABG) plus medical treatment
Other: Revascularisation and optimal medical treatment
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
After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.
30-day mortality
30-day all-cause death after randomization according to the intention-to-treat principle
Time frame: 30 days
Time to death within 6 and 12 months follow-up
Time frame: 6 and 12 months
Length of mechanical ventilation
Time frame: 0 to 10 days
Time to hemodynamic stabilization
Time frame: 0 to 10 days
Duration of catecholamine therapy
Time frame: 0 to 10 days
Serial creatinine-level and creatinine-clearance
Creatinine-clearance (Cockcroft-Gault-Formula)
Time frame: 0 to 10 days from time of randomization until stabilization
Length of ICU stay
Time frame: 0 to 11 days
Length of hospital stay
Time frame: 0 to 14 days
Serial SAPS-II score
Time frame: 0 to 11 days
Mean and area under the curve of arterial lactate
Time frame: 0 to 14 days
Acute renal failure requiring renal replacement therapy
Time frame: 0 to 14 days
Cerebral performance category (CPC)
Time frame: 30 days, 6 and 12 months
Cardiovascular mortality
Time frame: 6 and 12 months
Hospitalization for heart failure
Time frame: 6 and 12 months
Recurrent infarction
Time frame: 30 days, 6 and 12 months
Repeat revascularization (PCI or CABG)
Time frame: 30 days, 6 and 12 months
Status of Quality of life measured by EQ-5D-5L descriptive system
The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems expressed by 1-digit-numbers ranging from 1 (extreme problems) to 5 (no problems). The toal score ranges from 0-15 where 15 is the worst score.
Time frame: 12 months
Status of Quality of life measured by EQ VAS
The EuroQol Group visual analogue scale (EQ VAS) records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the maximum 100 is labelled 'The best health you can imagine' and the minimum 0 is labelled 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Helios Health Institute GmbH