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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Urmia University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Chancellor of research, Urmia University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT02070679
First received: February 21, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted

February 21, 2014
February 21, 2014
February 2014
December 2014   (final data collection date for primary outcome measure)
The development of CI-AKI in group receiving vitamin E compared with placebo [ Time Frame: Within 72 hours after coronary angiography ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Changes in the serum level of Cr and the amount of eGFR [ Time Frame: Within 72 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy of Vitamin E in Preventing Contrast-Induced Acute Kidney Injury Following Coronary Angiography
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Stable Angina
  • Unstable Angina
  • Non ST Segment Elevation Myocardial Infarction
  • Post MI
Drug: Vitamin E
Other Name: Alpha-tocopherol
  • Placebo Comparator: Placebo
  • Active Comparator: Vit-E
    600 IU on 12 hours before angiography and 400 IU on 2 hours before angiography
    Intervention: Drug: Vitamin E
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
290
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Not Provided
Contact: Mir Hossein Seyyed-Mohammadzad, Interventionist +989143458377 mmohammadzad@gmail.com
Contact: Yousef Rezaei +989126231864 yousefrezaei1986@gmail.com
Iran, Islamic Republic of
 
NCT02070679
UMSU-Cardiology-1
Yes
Chancellor of research, Urmia University of Medical Sciences
Urmia University of Medical Sciences
Not Provided
Not Provided
Urmia University of Medical Sciences
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP