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Pilot study for CHAOS-Two (Cambridge Heart Anti-Oxidant study: trial with other vitamins)

Pilot study for CHAOS-Two (Cambridge Heart Anti-Oxidant study: trial with other vitamins)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN41864011
Enrollment
Unknown
Registered
2004-01-23
Start date
1997-07-01
Completion date
Unknown
Last updated
2018-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart disease Circulatory System Chronic ischaemic heart disease

Interventions

1. Folate 5 mg 2. Placebo

Sponsors

NHS R&D Regional Programme Register - Department of Health (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients admitted for coronary angiograph 2. Stable angina 3. Positive coronary angiogram

Exclusion criteria

Exclusion criteria: Patients with a macrocytic anaemia (Hb 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.

Design outcomes

Primary

MeasureTime frame
1. Main Study 1.1. Fatal or non-fatal myocardial infarction. 2. Pilot Study 2.1. Percentage of patients with B12 deficiency on entry despite normal Hb and MCV, and patients becoming B12 deficient at follow-ups. 2.2. Percentage change in plasma homocysteine and plasma tetrahydrobiopterin in response to folic acid, and variation in these over one year. 2.3. Compliance with treatment addeddes from rise in rbc folate in active group. 2.4. Estimate of number of eligible patients likely to be recruited annually.

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026