The Effects of Folic Acid on Vascular Function in Patients with Coronary Artery Disease
| ISRCTN | ISRCTN47956475 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47956475 |
| Protocol serial number | Version 2 |
| Sponsor | University of Oxford (UK) |
| Funder | British Heart Foundation (BHF JRF No: FS/03/105/16340) |
- Submission date
- 06/03/2006
- Registration date
- 06/03/2006
- Last edited
- 07/12/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Keith Channon
Scientific
Scientific
Department of Cardiovascular Medicine
University of Oxford
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Placebo-controlled randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Folic acid improves vascular function in patients with coronary artery disease |
| Ethics approval(s) | The study has been approved by the Oxford Local Research Ethics Committee (Ref no. 04.OXB.004) |
| Health condition(s) or problem(s) studied | Coronary artery disease |
| Intervention | Folic acid versus placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Folic acid |
| Primary outcome measure(s) | Improvement in Magnetic Resonance (MR) measures of vascular function |
| Key secondary outcome measure(s) | Improvement in laboratory measures of vascular function |
| Completion date | 30/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | Patients with coronary artery disease |
| Key exclusion criteria | 1. Metallic implants or contraindications to Magnetic Resonance Imaging (MRI) 2. Severe renal or hepatic dysfunction 3. Recent acute coronary event |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 30/04/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Cardiovascular Medicine
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2007 | Yes | No |
