Unstable Angina Clinical Trial
Verified date | June 2015 |
Source | Urmia University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ethics Committee |
Study type | Interventional |
The purpose of this study is to evaluate the effect of vitamin E on preventing from incidence of contrast induced acute kidney injury (CI-AKI) in the patients who undergone coronary angiography.
Status | Completed |
Enrollment | 284 |
Est. completion date | June 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. All patients whon have either stable coronary artery disease (CAD) or recent acute coronary disease (ACS) and are scheduled for coronary angiography. 2. Patients who have eGFR =60 ml/min/1.73 m2 Exclusion Criteria: 1. Allergy to contrast media 2. Cardiogenic shock 3. Pulmonary edema 4. Overt cardiac failure or left ventricular ejection fraction = 30% 5. Acute kidney injury 6. The history of receiving contrast media for any medical diagnostic or therapeutic procedures during previous 5 days 7. The history of dialysis 8. Being pregnant 9. Having recent acute myocardial infarction 10. Taking antioxidants and nephrotoxic drugs including NSAID and ACE-I on previous 2 days |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Seyyed-al-Shohada Heart Center, UMSU | Urmia | West-Azerbaijan |
Iran, Islamic Republic of | Taleghani Hospital, UMSU | Urmia | West-Azerbaijan |
Lead Sponsor | Collaborator |
---|---|
Urmia University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The development of CI-AKI in group receiving vitamin E compared with placebo | Within 72 hours after coronary angiography | Yes | |
Secondary | Changes in the serum level of Cr and the amount of eGFR | Within 72 hours | Yes |
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