Efficacy of Vitamin E in Preventing Contrast-Induced Acut... | NCT02070679

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

NCT02070679

Sponsor

Urmia University of Medical Sciences

Status

Completed

Last Update Posted

Jun 16, 2015Estimated

Enrollment

284Actual

Phase

Phase 3

Conditions

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

Interventions

Vitamin E

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

May 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Feb 21, 2014

First Submission Date that Met QC Criteria

Feb 21, 2014

First Posted Date

Feb 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2015

Last Update Posted Date

Jun 16, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chancellor of research, Mir Hossein Seyyed-Mohammadzad, Urmia University of Medical SciencesPrincipal Investigator

Lead Sponsor

Urmia University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

284Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vitamin E	Drug		Vit-E	Alpha-tocopherol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The development of CI-AKI in group receiving vitamin E compared with placebo		Within 72 hours after coronary angiography

Secondary Outcomes

Measure	Description	Time Frame
Changes in the serum level of Cr and the amount of eGFR		Within 72 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seyyed-al-Shohada Heart Center, UMSU		Urmia	West Azerbaijan Province		Iran
Taleghani Hospital, UMSU

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27068631	Derived	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.

ID	Term
D060050	Angina, Stable
D000789	Angina, Unstable

ID	Term
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D001578	Benzopyrans
D011714	Pyrans
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Term
D014810	Vitamin E
D024502	alpha-Tocopherol