Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein - Full Text View

Purpose

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	Intervention	Phase
Myocardial Infarction	Drug: Acetylcystein Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:

Myocardial salvage measured by magnetic resonance imaging [ Time Frame: 4 days ] [ Designated as safety issue: No ]
prevention of nephropathy [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ST-segment resolution [ Time Frame: 90 min ] [ Designated as safety issue: No ]
TIMI flow [ Time Frame: minutes ] [ Designated as safety issue: No ]
composite clinical endpoint (death, reinfarction, congestive heart failure) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
need for dialysis [ Time Frame: 4 days ] [ Designated as safety issue: No ]
microvascular obstruction measured by magnetic resonance [ Time Frame: 4 days ] [ Designated as safety issue: No ]
infarct size measured by magnetic resonance [ Time Frame: 4 days ] [ Designated as safety issue: No ]
oxidative stress [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Enrollment:	251
Study Start Date:	December 2006
Study Completion Date:	June 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463749

Locations

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

Sponsors and Collaborators

University of Leipzig

Investigators

Study Chair:

Holger Thiele, MD

University of Leipzig

More Information

No publications provided by University of Leipzig

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

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.

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. 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. 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.

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.

Responsible Party:	Holger Thiele, MD, University of Leipzig - Heart Center
ClinicalTrials.gov Identifier:	NCT00463749 History of Changes
Other Study ID Numbers:	1111/2006
Study First Received:	April 18, 2007
Last Updated:	July 7, 2008
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:

primary PCI
nephropathy
infarct size
infarction
ST-elevation myocardial infarction

Additional relevant MeSH terms:

Infarction
Kidney Diseases
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis

Urologic Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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