Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein
LIPSIA-N-ACC
Trial to Compare Infarct Size and Occurrence of Contrast Dye Induced Nephropathy in Patients With Primary Percutaneous PCI in STEMI
1 other identifier
interventional
251
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 18, 2007
CompletedFirst Posted
Study publicly available on registry
April 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedJuly 8, 2008
July 1, 2008
1.2 years
April 18, 2007
July 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Myocardial salvage measured by magnetic resonance imaging
4 days
prevention of nephropathy
3 days
Secondary Outcomes (7)
ST-segment resolution
90 min
TIMI flow
minutes
composite clinical endpoint (death, reinfarction, congestive heart failure)
30 days
need for dialysis
4 days
microvascular obstruction measured by magnetic resonance
4 days
- +2 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORHigh-dose N-Acetylcystein during percutaneous coronary intervention and for 2 days post intervention 2 x/day
2
PLACEBO COMPARATORPlacebo (NaCl)
Interventions
Eligibility Criteria
You may qualify if:
- ST-elevation infarction (\<12 hours)
- Angina
You may not qualify if:
- Prior fibrinolysis
- Dialysis
- Pregnancy
- Lactase-reduction
- Glucose-galactose malabsorption
- Known allergy to acetylcystein
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Leipzig - Heart Center
Leipzig, 04289, Germany
Related Publications (7)
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.
PMID: 24962156DERIVEDFuernau 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.
PMID: 22704876DERIVEDFuernau 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.
PMID: 21920334DERIVEDDroppa 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.
PMID: 21710343DERIVEDEitel 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.
PMID: 21345844DERIVEDThiele 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.
PMID: 20466200DERIVEDEitel 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.
PMID: 20435200DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Holger Thiele, MD
Heart Center Leipzig - University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 18, 2007
First Posted
April 20, 2007
Study Start
December 1, 2006
Primary Completion
February 1, 2008
Study Completion
June 1, 2008
Last Updated
July 8, 2008
Record last verified: 2008-07