Does helium protect the heart against ischaemia-reperfusion damage in patients with acute myocardial infarction? - Helium-MI

• Conditions: Acute myocardial infarction; MedDRA version: 12.1Level: LLTClassification code 10000891Term: Acute myocardial infarction; MedDRA version: 12.1Level: LLTClassification code 10051624Term: Myocardial reperfusion injury; MedDRA version: 12.1Level: LLTClassification code 10063837Term: Reperfusion injury

• Registration Number: EUCTR2010-022393-13-NL
• Lead Sponsor: Academical Medical Center, University of Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Age 18-75
ST-elevation myocardial infarction, which will be treated by primary PCI
Chest pain of less then 12 hours duration
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Left bundle branch block
Previous MI
Fibrinolytic treatment in the previous 30 days
Prior coronary artery bypass grafting surgery
Left main stenosis, requiring coronary artery bypass grafting surgery
Severe heart failure, as witnessedby any of the folowing: need for mechinal ventilation, need for an intra-aortic balloon bup or Impella, or the need of high dosage of catechomalines
Use of glibenclamide
Kidney failure
A contraindication for MRI

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified