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Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00237614
First received: October 7, 2005
Last updated: July 17, 2006
Last verified: July 2005
History of Changes
  Purpose

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 Intervention Phase
Contrast-Induced Nephropathy
Acute Myocardial Infarction
 Drug: intravenous and oral N-acetylcysteine
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Milan:

Primary Outcome Measures:
  • Incidence of contrast-induced nephropathy

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

Estimated Enrollment: 300
Study Start Date: February 2003
Estimated Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237614

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

Publications:

ClinicalTrials.gov Identifier: NCT00237614     History of Changes
Other Study ID Numbers: CCS16 RC/2003
Study First Received: October 7, 2005
Last Updated: July 17, 2006
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Infarction
Kidney Diseases
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Urologic Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Acetylcysteine
N-monoacetylcystine
 Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on May 16, 2013