Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein (LIPSIA-N-ACC)
July 7, 2008 updated by: University of Leipzig
Trial to Compare Infarct Size and Occurrence of Contrast Dye Induced Nephropathy in Patients With Primary Percutaneous PCI in STEMI
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
251
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leipzig, Germany, 04289
- University of Leipzig - Heart Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ST-elevation infarction (<12 hours)
- Angina
Exclusion Criteria:
- Prior fibrinolysis
- Dialysis
- Pregnancy
- Lactase-reduction
- Glucose-galactose malabsorption
- Known allergy to acetylcystein
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
Placebo (NaCl)
|
NaCl as placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Myocardial salvage measured by magnetic resonance imaging
Time Frame: 4 days
|
4 days
|
|
prevention of nephropathy
Time Frame: 3 days
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
ST-segment resolution
Time Frame: 90 min
|
90 min
|
|
TIMI flow
Time Frame: minutes
|
minutes
|
|
composite clinical endpoint (death, reinfarction, congestive heart failure)
Time Frame: 30 days
|
30 days
|
|
need for dialysis
Time Frame: 4 days
|
4 days
|
|
microvascular obstruction measured by magnetic resonance
Time Frame: 4 days
|
4 days
|
|
infarct size measured by magnetic resonance
Time Frame: 4 days
|
4 days
|
|
oxidative stress
Time Frame: 72 hours
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Holger Thiele, MD, Heart Center Leipzig - University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- de Waha S, Eitel I, Desch S, Fuernau G, Lurz P, Stiermaier T, Blazek S, Schuler G, Thiele H. Prognosis after ST-elevation myocardial infarction: a study on cardiac magnetic resonance imaging versus clinical routine. Trials. 2014 Jun 25;15:249. doi: 10.1186/1745-6215-15-249.
- Fuernau G, Zaehringer S, Eitel I, de Waha S, Droppa M, Desch S, Schuler G, Adams V, Thiele H. Osteoprotegerin in ST-elevation myocardial infarction: prognostic impact and association with markers of myocardial damage by magnetic resonance imaging. Int J Cardiol. 2013 Sep 1;167(5):2134-9. doi: 10.1016/j.ijcard.2012.05.101. Epub 2012 Jun 15.
- Fuernau G, Eitel I, Franke V, Hildebrandt L, Meissner J, de Waha S, Lurz P, Gutberlet M, Desch S, Schuler G, Thiele H. Myocardium at risk in ST-segment elevation myocardial infarction comparison of T2-weighted edema imaging with the MR-assessed endocardial surface area and validation against angiographic scoring. JACC Cardiovasc Imaging. 2011 Sep;4(9):967-76. doi: 10.1016/j.jcmg.2011.02.023.
- Droppa M, Desch S, Blase P, Eitel I, Fuernau G, Schuler G, Adams V, Thiele H. Impact of N-acetylcysteine on contrast-induced nephropathy defined by cystatin C in patients with ST-elevation myocardial infarction undergoing primary angioplasty. Clin Res Cardiol. 2011 Nov;100(11):1037-43. doi: 10.1007/s00392-011-0338-8. Epub 2011 Jun 28.
- Eitel I, Blase P, Adams V, Hildebrand L, Desch S, Schuler G, Thiele H. Growth-differentiation factor 15 as predictor of mortality in acute reperfused ST-elevation myocardial infarction: insights from cardiovascular magnetic resonance. Heart. 2011 Apr;97(8):632-40. doi: 10.1136/hrt.2010.219543. Epub 2011 Feb 22.
- Thiele H, Hildebrand L, Schirdewahn C, Eitel I, Adams V, Fuernau G, Erbs S, Linke A, Diederich KW, Nowak M, Desch S, Gutberlet M, Schuler G. Impact of high-dose N-acetylcysteine versus placebo on contrast-induced nephropathy and myocardial reperfusion injury in unselected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. The LIPSIA-N-ACC (Prospective, Single-Blind, Placebo-Controlled, Randomized Leipzig Immediate PercutaneouS Coronary Intervention Acute Myocardial Infarction N-ACC) Trial. J Am Coll Cardiol. 2010 May 18;55(20):2201-9. doi: 10.1016/j.jacc.2009.08.091.
- Eitel I, Nowak M, Stehl C, Adams V, Fuernau G, Hildebrand L, Desch S, Schuler G, Thiele H. Endothelin-1 release in acute myocardial infarction as a predictor of long-term prognosis and no-reflow assessed by contrast-enhanced magnetic resonance imaging. Am Heart J. 2010 May;159(5):882-90. doi: 10.1016/j.ahj.2010.02.019.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
April 18, 2007
First Submitted That Met QC Criteria
April 18, 2007
First Posted (Estimate)
April 20, 2007
Study Record Updates
Last Update Posted (Estimate)
July 8, 2008
Last Update Submitted That Met QC Criteria
July 7, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1111/2006
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