Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237614
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : July 18, 2006
Information provided by:
University of Milan

Brief Summary:
Patients with acute myocardial infarction undergoing primary angioplasty are at high risk for renal injury due to the toxic effect of contrast agents. Patients developing renal dysfunction after primary angioplasty have worse outcome. To investigate the role of the antioxidant N-acetylcysteine (NAC) in preventing renal injury in angioplasty, we randomized 352 consecutive patients undergoing primary angioplasty into three groups: the first group received NAC at standard dose (NAC group, 600 mg i.v. bolus before primary angioplasty, followed by oral 600 mg twice daily for the following 48 hours; n=115), the second group received NAC at double dose (DD-NAC group; 1,200 mg i.v. bolus and oral 1,200 mg twice daily for 48 hours; n=118), and the last group received placebo (controls; n=119).

Condition or disease Intervention/treatment Phase
Contrast-Induced Nephropathy Acute Myocardial Infarction Drug: intravenous and oral N-acetylcysteine Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Study Start Date : February 2003
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Incidence of contrast-induced nephropathy

Secondary Outcome Measures :
  1. In-hospital major clinical adverse events including death

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:Consecutive patients admitted to the Coronary Care Unit for ST-segment elevation acute myocardial infarction undergoing primary angioplasty. Patients were included if they presented within 12 hours (18 hours for acute myocardial infarction complicated by cardiogenic shock) from the onset of symptoms. -

Exclusion Criteria:Patients in chronic peritoneal or hemodialytic treatment and those with known allergy to N-acetylcysteine.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00237614

Centro Cardiologico Monzino
Milan, Italy, 20138
Sponsors and Collaborators
University of Milan
Study Director: Antonio L Bartorelli, MD Centro Cardiologico Monzino

Publications of Results:
Other Publications: Identifier: NCT00237614     History of Changes
Other Study ID Numbers: CCS16 RC/2003
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: July 18, 2006
Last Verified: July 2005

Keywords provided by University of Milan:
Contrast-induced nephropathy
Acute myocardial infarction
Primary coronary angioplasty

Additional relevant MeSH terms:
Myocardial Infarction
Kidney Diseases
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Urologic Diseases
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs