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

Sponsored by:	University of Leipzig
Information provided by:	University of Leipzig
ClinicalTrials.gov Identifier:	NCT00463749

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 III

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Trial to Compare Infarct Size and Occurrence of Contrast Dye Induced Nephropathy in Patients With Primary Percutaneous PCI in STEMI

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
1: Active Comparator 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
2: Placebo Comparator 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

Responsible Party:	University of Leipzig - Heart Center ( Holger Thiele, MD )
Study ID Numbers:	1111/2006
Study First Received:	April 18, 2007
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00463749
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

Study placed in the following topic categories:

Necrosis
Heart Diseases
Urologic Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Kidney Diseases
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009