search
Back to results

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

Primary Purpose

Stable Angina, Unstable Angina, Non ST Segment Elevation Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vitamin E
Sponsored by
Urmia University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stable Angina focused on measuring Alpha-tocopherol, Vitamin E, Contrast-Induced Acute Kidney Injury, Coronary angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seyyed-al-Shohada Heart Center, UMSU
  • Taleghani Hospital, UMSU

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Vit-E

Arm Description

600 IU on 12 hours before angiography and 400 IU on 2 hours before angiography

Outcomes

Primary Outcome Measures

The development of CI-AKI in group receiving vitamin E compared with placebo

Secondary Outcome Measures

Changes in the serum level of Cr and the amount of eGFR

Full Information

First Posted
February 21, 2014
Last Updated
June 13, 2015
Sponsor
Urmia University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT02070679
Brief Title
Efficacy of Vitamin E in Preventing Contrast-Induced Acute Kidney Injury Following Coronary Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Urmia University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina, Unstable Angina, Non ST Segment Elevation Myocardial Infarction, Post MI
Keywords
Alpha-tocopherol, Vitamin E, Contrast-Induced Acute Kidney Injury, Coronary angiography

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Vit-E
Arm Type
Active Comparator
Arm Description
600 IU on 12 hours before angiography and 400 IU on 2 hours before angiography
Intervention Type
Drug
Intervention Name(s)
Vitamin E
Other Intervention Name(s)
Alpha-tocopherol
Primary Outcome Measure Information:
Title
The development of CI-AKI in group receiving vitamin E compared with placebo
Time Frame
Within 72 hours after coronary angiography
Secondary Outcome Measure Information:
Title
Changes in the serum level of Cr and the amount of eGFR
Time Frame
Within 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients whon have either stable coronary artery disease (CAD) or recent acute coronary disease (ACS) and are scheduled for coronary angiography. Patients who have eGFR ≤60 ml/min/1.73 m2 Exclusion Criteria: Allergy to contrast media Cardiogenic shock Pulmonary edema Overt cardiac failure or left ventricular ejection fraction ≤ 30% Acute kidney injury The history of receiving contrast media for any medical diagnostic or therapeutic procedures during previous 5 days The history of dialysis Being pregnant Having recent acute myocardial infarction Taking antioxidants and nephrotoxic drugs including NSAID and ACE-I on previous 2 days
Facility Information:
Facility Name
Seyyed-al-Shohada Heart Center, UMSU
City
Urmia
State/Province
West-Azerbaijan
Country
Iran, Islamic Republic of
Facility Name
Taleghani Hospital, UMSU
City
Urmia
State/Province
West-Azerbaijan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27068631
Citation
Rezaei Y, Khademvatani K, Rahimi B, Khoshfetrat M, Arjmand N, Seyyed-Mohammadzad MH. Short-Term High-Dose Vitamin E to Prevent Contrast Medium-Induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Elective Coronary Angiography: A Randomized Placebo-Controlled Trial. J Am Heart Assoc. 2016 Mar 15;5(3):e002919. doi: 10.1161/JAHA.115.002919.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs