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

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ClinicalTrials.gov Identifier: NCT02070679
Recruitment Status : Completed
First Posted : February 25, 2014
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Chancellor of research, 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : February 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The development of CI-AKI in group receiving vitamin E compared with placebo [ Time Frame: Within 72 hours after coronary angiography ]

Secondary Outcome Measures :
  1. Changes in the serum level of Cr and the amount of eGFR [ Time Frame: Within 72 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070679


Locations
Iran, Islamic Republic of
Seyyed-al-Shohada Heart Center, UMSU
Urmia, West-Azerbaijan, Iran, Islamic Republic of
Taleghani Hospital, UMSU
Urmia, West-Azerbaijan, Iran, Islamic Republic of
Sponsors and Collaborators
Urmia University of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Angina Pectoris
Acute Kidney Injury
Angina, Stable
Angina, Unstable
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants