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NCT02070679 Clinical Trial

Efficacy of Vitamin E in Preventing Contrast-Induced Acute Kidney Injury Following Coronary Angiography

Stable Angina Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02070679
Other study ID # UMSU-Cardiology-1
Secondary ID
Status Completed
Phase Phase 3
First received February 21, 2014
Last updated June 13, 2015
Start date February 2014
Est. completion date June 2015

Study information
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

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Vitamin E

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Urmia University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
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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