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Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00237614
Enrollment
300
Registered
2005-10-12
Start date
2003-02-28
Completion date
2005-05-31
Last updated
2006-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Contrast-Induced Nephropathy

Keywords

Contrast-induced nephropathy, Acute myocardial infarction, Primary coronary angioplasty

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).

Interventions

DRUGintravenous and oral N-acetylcysteine

Sponsors

University of Milan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frame
Incidence of contrast-induced nephropathy

Secondary

MeasureTime frame
In-hospital major clinical adverse events including death

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026