Does helium protect the heart against ischaemia-reperfusion damage in patients with acute myocardial infarction?
Phase 2
- Conditions
- Myocardial infarction10011082
- Registration Number
- NL-OMON34155
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
Age 18-75 years
STEMI, treatment with primary PCI
Chest pain duration less than 12 hours
Exclusion Criteria
Left bundle-branch block
Trombolytic therapy in the last 30 days
Prio infarction
Prior CABG
Left main stenosis, requiring CABG
Mechanical ventilation
High catecholamines usages
IABP or Impella
Glibenclamide usage
Kidney failure
Contraindication for MRI
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Infarct size as percentage of the area at risk, determined by MRI 2-4 days<br /><br>after PCI. </p><br>
- Secondary Outcome Measures
Name Time Method <p>MRI on day 2-4: infarct size, area-at-risk (=edema), left ventricular volumes<br /><br>(LVEDV, LVESV) and ejection fraction<br /><br>MRI after 4 months: infarct size, left ventricular volumes (LVEDV, LVESV) and<br /><br>ejection fraction<br /><br>Troponin: at baseline, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36<br /><br>hours, 42 hours and 48 hours<br /><br>NT-proBNP at baseline, 6 hours, 12 hours, 24 hours, 48 hours, 4 days and 4<br /><br>months<br /><br>MACE rate during 4 month follow-up<br /><br>NYHA class at 30 days and 4 months</p><br>