Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein (LIPSIA-N-ACC)

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ClinicalTrials.gov Identifier: NCT00463749

Recruitment Status : Completed

First Posted : April 20, 2007

Last Update Posted : July 8, 2008

Sponsor:

Information provided by:

University of Leipzig

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Myocardial Infarction	Drug: Acetylcystein Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	251 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
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
Study Start Date :	December 2006
Actual Primary Completion Date :	February 2008
Actual Study Completion Date :	June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1 High-dose N-Acetylcystein during percutaneous coronary intervention and for 2 days post intervention 2 x/day	Drug: Acetylcystein high-dose N-Acetylcystein during PCI and for 2/day for 2 days
Placebo Comparator: 2 Placebo (NaCl)	Drug: Placebo NaCl as placebo

Outcome Measures

Primary Outcome Measures :

Myocardial salvage measured by magnetic resonance imaging [ Time Frame: 4 days ]
prevention of nephropathy [ Time Frame: 3 days ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ST-elevation infarction (<12 hours)
Angina

Exclusion Criteria:

Prior fibrinolysis
Dialysis
Pregnancy
Lactase-reduction
Glucose-galactose malabsorption
Known allergy to acetylcystein

Contacts and Locations

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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

Locations

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Germany
University of Leipzig - Heart Center
Leipzig, Germany, 04289

Sponsors and Collaborators

University of Leipzig

Investigators

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Study Chair:	Holger Thiele, MD	Heart Center Leipzig - University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Holger Thiele, MD, University of Leipzig - Heart Center
ClinicalTrials.gov Identifier:	NCT00463749
Other Study ID Numbers:	1111/2006
First Posted:	April 20, 2007 Key Record Dates
Last Update Posted:	July 8, 2008
Last Verified:	July 2008

Keywords provided by University of Leipzig:


primary PCI nephropathy infarct size infarction ST-elevation myocardial infarction

Additional relevant MeSH terms:

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Kidney Diseases Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis	Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Urologic Diseases

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