Trial to Compare Infarct Size and Occurrence of Contrast Dye Induced Nephropathy in Patients With Primary Percutaneous PCI in STEMI
Overview
- Phase
- Phase 3
- Intervention
- Acetylcystein
- Conditions
- Myocardial Infarction
- Sponsor
- University of Leipzig
- Enrollment
- 251
- Locations
- 1
- Primary Endpoint
- Myocardial salvage measured by magnetic resonance imaging
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
Acetylcystein is a potent antioxidans which is able to prevent contrast dye induced nephropathy in stable patients undergoing additional hydration.
In primary percutaneous intervention for infarction hydration is not possible. Therefore Acetylcystein might prevent contrast dye induced nephropathy.
Furthermore, it might reduce infarct size as a result of its antioxidant properties.
Clinical trials are missing so far examining the effects of Acetylcystein on nephropathy and infarct size.
Investigators
Eligibility Criteria
Inclusion Criteria
- •ST-elevation infarction (\<12 hours)
Exclusion Criteria
- •Prior fibrinolysis
- •Pregnancy
- •Lactase-reduction
- •Glucose-galactose malabsorption
- •Known allergy to acetylcystein
Arms & Interventions
1
High-dose N-Acetylcystein during percutaneous coronary intervention and for 2 days post intervention 2 x/day
Intervention: Acetylcystein
2
Placebo (NaCl)
Intervention: Placebo
Outcomes
Primary Outcomes
Myocardial salvage measured by magnetic resonance imaging
Time Frame: 4 days
prevention of nephropathy
Time Frame: 3 days
Secondary Outcomes
- TIMI flow(minutes)
- composite clinical endpoint (death, reinfarction, congestive heart failure)(30 days)
- ST-segment resolution(90 min)
- need for dialysis(4 days)
- oxidative stress(72 hours)
- microvascular obstruction measured by magnetic resonance(4 days)
- infarct size measured by magnetic resonance(4 days)