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

NCT02070679 | Completed Phase 3 DMC

• 1 other identifier: UMSU-Cardiology-1
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 2

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.

Conditions

Stable Angina; Unstable Angina; Non ST Segment Elevation Myocardial Infarction; Post MI

Keywords

Alpha-tocopherol; Vitamin E; Contrast-Induced Acute Kidney Injury; Coronary angiography

Outcome Measures

Primary Outcomes (1)

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

  Within 72 hours after coronary angiography

Secondary Outcomes (1)

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

  Within 72 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Vit-E

ACTIVE COMPARATOR

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

Drug: Vitamin E

Interventions

Vitamin E DRUG

Also known as: Alpha-tocopherol

Vit-E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Urmia University of Medical Sciences: lead

Study Sites (2)

Seyyed-al-Shohada Heart Center, UMSU

Urmia, West Azerbaijan Province, Iran

Location

Taleghani Hospital, UMSU

Urmia, West Azerbaijan Province, Iran

Location

Related Publications (1)

• 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.

  PMID: 27068631 DERIVED

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable

Interventions

Vitamin E; alpha-Tocopherol

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tocopherols

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mir Hossein Seyyed-Mohammadzad

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

IR (2)