Pilot study for CHAOS-Two (Cambridge Heart Anti-Oxidant study: trial with other vitamins)
| ISRCTN | ISRCTN41864011 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41864011 |
| Protocol serial number | Brown HSR/06/97 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Eastern (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 30/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University of Cambridge
Clinical Pharmacology Unit
Level 6, ACCI
Hills Road
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 336743 |
|---|---|
| mjb14@medschl.cam.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Pilot study for CHAOS-Two (Cambridge Heart Anti-Oxidant study: trial with other vitamins) |
| Study acronym | CHAOS-Two |
| Study objectives | The overall aim of CHAOS-Two is to determine whether folic acid reduces the incidence of myocardial infarction. The principle current hypothesis on which to base expectation of benefit is a well documented effect of folic acid to reduce plasma levels of the amino acid, homocysteine, which has been found in several prospective and case-control studies to be a major risk factor for atherosclerotic diseases. CHAOS-Two should thus provide a test of the homocysteine hypothesis. However, an additional pathway through which folic acid may be beneficial is the so-called salvage pathway to synthesis of the co-factor, tetrahydrobiopterin, required for Nitric Oxide (NO) synthesis. The principle requirement of the pilot study is to permit calculation of numbers required for the main study, using the relative risk of homocysteine in the epidemiological studies, and the average difference after 1 year between homocysteine levels in the folate and placebo groups. The pilot will also establish whether folic acid had the additional action via NO. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Heart disease |
| Intervention | 1. Folate 5 mg 2. Placebo |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Main Study |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/07/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | 1. Patients admitted for coronary angiograph 2. Stable angina 3. Positive coronary angiogram |
| Key exclusion criteria | Patients with a macrocytic anaemia (Hb <10, mean cell volume [MCV] >100) will be excluded from the pilot unless their serum B12 is normal. To be revised if indicated by follow-up results of Hb and B12 pilot. |
| Date of first enrolment | 01/07/1997 |
| Date of final enrolment | 01/07/1999 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CB2 2QQ
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 |
Editorial Notes
30/04/2018: No publications found, verifying study status with principal investigator.
04/03/2016: No publications found, verifying study status with principal investigator.
