Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction

University of Milan

Status and phase

Completed

Phase 3

Phase 2

Conditions

Acute Myocardial Infarction

Contrast-Induced Nephropathy

Treatments

Drug: intravenous and oral N-acetylcysteine

Study type

Interventional

Funder types

Other

Identifiers

NCT00237614

CCS16 RC/2003

Details and patient eligibility

About

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).

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.