Back to resultsContrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction
Primary Purpose
Contrast-Induced Nephropathy, Acute Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
intravenous and oral N-acetylcysteine
Sponsored by
About this trial
This is an interventional prevention trial for Contrast-Induced Nephropathy focused on measuring Contrast-induced nephropathy, Acute myocardial infarction, Primary coronary angioplasty
Eligibility 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. -
Sites / Locations
- Centro Cardiologico Monzino
Outcomes
Primary Outcome Measures
Incidence of contrast-induced nephropathy
Secondary Outcome Measures
In-hospital major clinical adverse events including death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00237614
Brief Title
Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Milan
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast-Induced Nephropathy, Acute Myocardial Infarction
Keywords
Contrast-induced nephropathy, Acute myocardial infarction, Primary coronary angioplasty
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
intravenous and oral N-acetylcysteine
Primary Outcome Measure Information:
Title
Incidence of contrast-induced nephropathy
Secondary Outcome Measure Information:
Title
In-hospital major clinical adverse events including death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio L Bartorelli, MD
Organizational Affiliation
Centro Cardiologico Monzino
Official's Role
Study Director
Facility Information:
Facility Name
Centro Cardiologico Monzino
City
Milan
ZIP/Postal Code
20138
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
15519007
Citation
Marenzi G, Lauri G, Assanelli E, Campodonico J, De Metrio M, Marana I, Grazi M, Veglia F, Bartorelli AL. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004 Nov 2;44(9):1780-5. doi: 10.1016/j.jacc.2004.07.043.
Results Reference
background
PubMed Identifier
16807414
Citation
Marenzi G, Assanelli E, Marana I, Lauri G, Campodonico J, Grazi M, De Metrio M, Galli S, Fabbiocchi F, Montorsi P, Veglia F, Bartorelli AL. N-acetylcysteine and contrast-induced nephropathy in primary angioplasty. N Engl J Med. 2006 Jun 29;354(26):2773-82. doi: 10.1056/NEJMoa054209.
Results Reference
result
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Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction
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