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Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction

This study has been completed.

Sponsored by: University of Milan
Information provided by: University of Milan
ClinicalTrials.gov Identifier: NCT00237614
  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 II
Phase III

MedlinePlus related topics:   Angioplasty    Heart Attack   

ChemIDplus related topics:   Acetylcysteine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Efficacy Study

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.

-

  Contacts and Locations

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

Locations
Italy
Centro Cardiologico Monzino    
      Milan, Italy, 20138
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 of Results:

Other Publications:

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

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

Study placed in the following topic categories:
Necrosis
Heart Diseases
Urologic Diseases
Myocardial Ischemia
Vascular Diseases
Acetylcysteine
Ischemia
Kidney Diseases
Infarction
Myocardial Infarction
N-monoacetylcystine

Additional relevant MeSH terms:
Respiratory System Agents
Anti-Infective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antiviral Agents
Protective Agents
Pharmacologic Actions
Pathologic Processes
Expectorants
Therapeutic Uses
Free Radical Scavengers
Cardiovascular Diseases
Antidotes

ClinicalTrials.gov processed this record on September 05, 2008




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