NCT00300352

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Last Updated

August 7, 2008

Status Verified

January 1, 2007

Enrollment Period

2 years

First QC Date

March 7, 2006

Last Update Submit

August 6, 2008

Conditions

Keywords

Coronary artery diseaseFolic acidEndothelial function

Outcome Measures

Primary Outcomes (1)

  • Improvement in noninvasive measures of vascular function

Secondary Outcomes (1)

  • Improvement in laboratory measures of vascular function

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of coronary artery disease

You may not qualify if:

  • Recent acute coronary event Renal and/or hepatic dysfunction Metallic implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford

Oxford, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Keith Channon, MD FRCP

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheerag C Shirodaria, MB BS MRCP

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2006

First Posted

March 8, 2006

Study Start

May 1, 2004

Primary Completion

May 1, 2006

Last Updated

August 7, 2008

Record last verified: 2007-01

Locations