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Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction

Phase 2
Completed
Conditions
Contrast-Induced Nephropathy
Acute Myocardial Infarction
Registration Number
NCT00237614
Lead Sponsor
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
300
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Incidence of contrast-induced nephropathy
Secondary Outcome Measures
NameTimeMethod
In-hospital major clinical adverse events including death

Trial Locations

Locations (1)

Centro Cardiologico Monzino

🇮🇹

Milan, Italy

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