Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction - Tabular View

Tracking Information

First Received Date ^ICMJE

October 7, 2005

Last Updated Date

July 17, 2006

Start Date ^ICMJE

February 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Incidence of contrast-induced nephropathy

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00237614 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

In-hospital major clinical adverse events including death

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction

Official Title ^ICMJE

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

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Contrast-Induced Nephropathy
Acute Myocardial Infarction

Intervention ^ICMJE

Drug: intravenous and oral N-acetylcysteine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

300

Completion Date

May 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00237614

Responsible Party

Study ID Numbers ^ICMJE

CCS16 RC/2003

Study Sponsor ^ICMJE

University of Milan

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Antonio L Bartorelli, MD

Centro Cardiologico Monzino

Information Provided By

University of Milan

Verification Date

July 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP