Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein
NCT ID: NCT00463749
Last Updated: 2008-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
251 participants
INTERVENTIONAL
2006-12-31
2008-06-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
High-dose N-Acetylcystein during percutaneous coronary intervention and for 2 days post intervention 2 x/day
Acetylcystein
high-dose N-Acetylcystein during PCI and for 2/day for 2 days
2
Placebo (NaCl)
Placebo
NaCl as placebo
Interventions
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Acetylcystein
high-dose N-Acetylcystein during PCI and for 2/day for 2 days
Placebo
NaCl as placebo
Eligibility Criteria
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Inclusion Criteria
* Angina
Exclusion Criteria
* Dialysis
* Pregnancy
* Lactase-reduction
* Glucose-galactose malabsorption
* Known allergy to acetylcystein
18 Years
ALL
No
Sponsors
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University of Leipzig
OTHER
Responsible Party
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University of Leipzig - Heart Center
Principal Investigators
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Holger Thiele, MD
Role: STUDY_CHAIR
Heart Center Leipzig - University Hospital
Locations
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University of Leipzig - Heart Center
Leipzig, , Germany
Countries
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References
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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.
Other Identifiers
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1111/2006
Identifier Type: -
Identifier Source: org_study_id