Skip to main content
OpenTrials
Completed

NCT Number: NCT00237614

Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contrast-induced Nephropathy Acute Myocardial Infarction

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centro Cardiologico Monzino

Milan, 20138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

intravenous and oral N-acetylcysteine

Drug

Primary outcomes

  1. Incidence of contrast-induced nephropathy

Secondary outcomes

  1. In-hospital major clinical adverse events including death

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Important dates

Study start
2003
Study completion
2005
First posted
Oct 12, 2005
Registry last updated
Jul 18, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.