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

Phase 3

Completed

• Conditions: Stable Angina; Unstable Angina; Non ST Segment Elevation Myocardial Infarction; Post MI
• Interventions: Drug: Vitamin E

• Registration Number: NCT02070679
• Lead Sponsor: Urmia University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2014-02-21
• Study First Posted: 2014-02-25
• Primary Completion: 2015-05
• Status Verified: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-13
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vit-E	Vitamin E	600 IU on 12 hours before angiography and 400 IU on 2 hours before angiography

Primary Outcome Measures

Name	Time	Method
The development of CI-AKI in group receiving vitamin E compared with placebo	Within 72 hours after coronary angiography

Secondary Outcome Measures

Name	Time	Method
Changes in the serum level of Cr and the amount of eGFR	Within 72 hours

Trial Locations

Locations (2)

Seyyed-al-Shohada Heart Center, UMSU; 🇮🇷 Urmia, West-Azerbaijan, Iran, Islamic Republic of

Taleghani Hospital, UMSU; 🇮🇷 Urmia, West-Azerbaijan, Iran, Islamic Republic of