Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Milan |
---|---|
Information provided by: | University of Milan |
ClinicalTrials.gov Identifier: | NCT00237614 |
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).
Condition | Intervention | Phase |
---|---|---|
Contrast-Induced Nephropathy Acute Myocardial Infarction |
Drug: intravenous and oral N-acetylcysteine |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Efficacy Study |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts 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.
-
Italy | |
Centro Cardiologico Monzino | |
Milan, Italy, 20138 | |
Centro Cardiologico Monzino | |
Milan, Italy, 20138 |
Study Director: | Antonio L Bartorelli, MD | Centro Cardiologico Monzino |
Study ID Numbers: | CCS16 RC/2003 |
Study First Received: | October 7, 2005 |
Last Updated: | July 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00237614 |
Health Authority: | Italy: Ministry of Health |
Contrast-induced nephropathy Acute myocardial infarction Primary coronary angioplasty |
Necrosis Heart Diseases Urologic Diseases Myocardial Ischemia Vascular Diseases Acetylcysteine |
Ischemia Kidney Diseases Infarction Myocardial Infarction N-monoacetylcystine |
Respiratory System Agents Anti-Infective Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antiviral Agents Protective Agents |
Pharmacologic Actions Pathologic Processes Expectorants Therapeutic Uses Free Radical Scavengers Cardiovascular Diseases Antidotes |