Back to resultsEffect of Folic Acid Treatment in Coronary Artery Disease
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Folic Acid
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring Coronary artery disease, Folic acid, Endothelial function
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of coronary artery disease Exclusion Criteria: Recent acute coronary event Renal and/or hepatic dysfunction Metallic implants
Sites / Locations
- University of OxfordRecruiting
Outcomes
Primary Outcome Measures
Improvement in noninvasive measures of vascular function
Secondary Outcome Measures
Improvement in laboratory measures of vascular function
Full Information
NCT ID
NCT00300352
First Posted
March 7, 2006
Last Updated
August 6, 2008
Sponsor
University of Oxford
Collaborators
British Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00300352
Brief Title
Effect of Folic Acid Treatment in Coronary Artery Disease
Official Title
Effect of Folic Acid Treatment in Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oxford
Collaborators
British Heart Foundation
4. Oversight
5. Study Description
Brief Summary
We seek to examine the effects of folic acid treatment on vascular function in patients with coronary artery disease. Our hypothesis is that folic acid treatment will improve vascular function
Detailed Description
Common vascular disease states including diabetes and atherosclerosis are associated with endothelial dysfunction, characterised by reduced bioactivity of nitric oxide (NO). Folates are thought to improve endothelial function,but the mechanism by which this effect occurs is poorly understood. We propose to study the effects of folate supplementation on endothelial function in patients with coronary artery disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Folic acid, Endothelial function
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Folic Acid
Primary Outcome Measure Information:
Title
Improvement in noninvasive measures of vascular function
Secondary Outcome Measure Information:
Title
Improvement in laboratory measures of vascular function
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of coronary artery disease
Exclusion Criteria:
Recent acute coronary event Renal and/or hepatic dysfunction Metallic implants
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheerag C Shirodaria, MB BS MRCP
Phone
+(44)1865-221866
Email
cheerag.shirodaria@cardiov.ox.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Channon, MD FRCP
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oxford
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Effect of Folic Acid Treatment in Coronary Artery Disease
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