Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein
Phase 3
Completed
- Conditions
- Myocardial Infarction
- Interventions
- Drug: PlaceboDrug: Acetylcystein
- Registration Number
- NCT00463749
- Lead Sponsor
- University of Leipzig
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 251
Inclusion Criteria
- ST-elevation infarction (<12 hours)
- Angina
Exclusion Criteria
- Prior fibrinolysis
- Dialysis
- Pregnancy
- Lactase-reduction
- Glucose-galactose malabsorption
- Known allergy to acetylcystein
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo Placebo (NaCl) 1 Acetylcystein High-dose N-Acetylcystein during percutaneous coronary intervention and for 2 days post intervention 2 x/day
- Primary Outcome Measures
Name Time Method prevention of nephropathy 3 days Myocardial salvage measured by magnetic resonance imaging 4 days
- Secondary Outcome Measures
Name Time Method ST-segment resolution 90 min TIMI flow minutes composite clinical endpoint (death, reinfarction, congestive heart failure) 30 days 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
Trial Locations
- Locations (1)
University of Leipzig - Heart Center
🇩🇪Leipzig, Germany