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 September 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: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Stable Angina
Unstable Angina
Non ST Segment Elevation Myocardial Infarction
Post MI
Drug: Vitamin E
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Urmia University of Medical Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Changes in the serum level of Cr and the amount of eGFR [ Time Frame: Within 72 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 290
Study Start Date: February 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Active Comparator: Vit-E
600 IU on 12 hours before angiography and 400 IU on 2 hours before angiography
Drug: Vitamin E
Other Name: Alpha-tocopherol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070679

Contacts
Contact: Mir Hossein Seyyed-Mohammadzad, M.D. +989143458377 mmohammadzad@gmail.com
Contact: Yousef Rezaei, M.D. +989126231864 yousefrezaei1986@gmail.com

Locations
Iran, Islamic Republic of
Seyyed-al-Shohada Heart Center, UMSU Recruiting
Urmia, West-Azerbaijan, Iran, Islamic Republic of
Contact: Mir Hossein Seyyed-Mohammadzad    +989143458377    mmohammadzad@gmail.com   
Principal Investigator: Yousef Rezaei, M.D         
Taleghani Hospital, UMSU Recruiting
Urmia, West-Azerbaijan, Iran, Islamic Republic of
Sponsors and Collaborators
Urmia University of Medical Sciences
  More Information

No publications provided

Responsible Party: Chancellor of research, Mir Hossein Seyyed-Mohammadzad, Urmia University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02070679     History of Changes
Other Study ID Numbers: UMSU-Cardiology-1
Study First Received: February 21, 2014
Last Updated: September 10, 2014
Health Authority: Iran: Ethics Committee

Keywords provided by Urmia University of Medical Sciences:
Alpha-tocopherol
Vitamin E
Contrast-Induced Acute Kidney Injury
Coronary angiography

Additional relevant MeSH terms:
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Infarction
Acute Kidney Injury
Myocardial Infarction
Angina, Unstable
Angina, Stable
Ischemia
Pathologic Processes
Necrosis
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014