Status:
UNKNOWN
Vitamin E and N-acetylcysteine for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization
Lead Sponsor:
Rajaie Cardiovascular Medical and Research Center
Conditions:
Coronary Artery Disease
Coronary Artery Angiography
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In a double-blinded randomized clinical trial, all patients undergoing coronary artery catheterization who will met our criteria, will be enrolled into three groups to receive either, vitamin e, n-ace...
Detailed Description
Patients aged ≥18 years with chronic kidney disease who undergo coronary catheterization will be enrolled into the study if they meet the inclusion criteria. Patients will be randomly assigned into th...
Eligibility Criteria
Inclusion
- Patients aged ≥18 years with baseline estimated glomerular filtration rate (eGFR) \<60 mL/min per 1.73 m2 (based on the Modification of Diet in Renal Disease study group formula) who undergo coronary catheterization (i.e. coronary angiography and percutaneous coronary intervention \[PCI\]) will be invited to the study if they meet the inclusion criteria: stable angina with ischemia and indication for coronary angiography, non-ST-segment elevation (NSTE) acute coronary syndrome (ACS) requiring an early invasive strategy, and patients undergoing elective PCI .
Exclusion
- acute ST-segment elevation myocardial infarction, high-risk NSTE-ACS warranting emergency coronary angiography (\<2 hours), cardiogenic shock, pulmonary edema, overt heart failure and/or ejection fraction \<30%, ACS undergoing coronary angiography or angioplasty during the previous 5 days, sensitivity to contrast medium, recent administration of contrast medium for any reason, AKI, history of dialysis, pregnancy, newly prescribed angiotensin converting enzyme inhibitors or angiotensin receptor blockers, bleeding and/or coagulopathy diseases, and consumption of nephrotoxic drugs, vitamin E, vitamin C, or N-acetylcysteine (NAC) at least 48 hours before intervention.
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03755700
Start Date
November 1 2018
End Date
December 31 2019
Last Update
November 30 2018
Active Locations (1)
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1
Rajaie cardiovascular medical and research center
Tehran, Iran, 1995614331