Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein (LIPSIA-N-ACC)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Trial to Compare Infarct Size and Occurrence of Contrast Dye Induced Nephropathy in Patients With Primary Percutaneous PCI in STEMI|
- Myocardial salvage measured by magnetic resonance imaging [ Time Frame: 4 days ]
- prevention of nephropathy [ Time Frame: 3 days ]
- ST-segment resolution [ Time Frame: 90 min ]
- TIMI flow [ Time Frame: minutes ]
- composite clinical endpoint (death, reinfarction, congestive heart failure) [ Time Frame: 30 days ]
- need for dialysis [ Time Frame: 4 days ]
- microvascular obstruction measured by magnetic resonance [ Time Frame: 4 days ]
- infarct size measured by magnetic resonance [ Time Frame: 4 days ]
- oxidative stress [ Time Frame: 72 hours ]
|Study Start Date:||December 2006|
|Study Completion Date:||June 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
High-dose N-Acetylcystein during percutaneous coronary intervention and for 2 days post intervention 2 x/day
high-dose N-Acetylcystein during PCI and for 2/day for 2 days
Placebo Comparator: 2
NaCl as placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463749
|University of Leipzig - Heart Center|
|Leipzig, Germany, 04289|
|Study Chair:||Holger Thiele, MD||Heartcenter Leipzig GmbH|