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

Unstable Angina Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070679
• Other study ID #: UMSU-Cardiology-1
• 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

• Acute Kidney Injury
• Angina, Stable
• Angina, Unstable
• Myocardial Infarction
• Non ST Segment Elevation Myocardial Infarction
• Post MI
• Stable Angina
• Unstable Angina

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