Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein (LIPSIA-N-ACC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00463749|
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : July 8, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Drug: Acetylcystein Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||251 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Trial to Compare Infarct Size and Occurrence of Contrast Dye Induced Nephropathy in Patients With Primary Percutaneous PCI in STEMI|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||June 2008|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463749
|University of Leipzig - Heart Center|
|Leipzig, Germany, 04289|
|Study Chair:||Holger Thiele, MD||Heartcenter Leipzig GmbH|