Homocysteine lowering and atherosclerosis reduction trial (HART)
- Conditions
- Atherosclerotic cardiovascular disease (CVD)Circulatory System
- Registration Number
- ISRCTN54227421
- Lead Sponsor
- McMaster University (Canada)
- Brief Summary
2008 baseline results in: https://www.ncbi.nlm.nih.gov/pubmed/18940900 (added 09/08/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 921
1. Women and men aged greater than or equal to 55 years at high risk for cardiovascular (CV) events with:
1.1. Documented (CAD):
1.1.1. History of prior myocardial infarction (MI)
1.1.2. Stable or unstable angina with documented multivessel coronary artery disease (CAD) or strongly positive stress test
1.1.3. Multivessel CAD and percutanerous transluminal coronary angioplasty (PTCA) greater than or equal to 6 months prior to randomisation
1.1.4. Multivessel CABG greater than or equal to 4 years prior to randomisation
1.1.5. Multivessel CAD on angiography
1.2. Documented peripheral vascular disease (PVD):
1.2.1. Previous limp bypass surgery and/or previous peripheral percutaneous transluminal angioplasty and/or previous limp or foot amputation due to PVD
1.2.2. History of intermittent claudication with ankle/arm blood pressure ratio of greater than or equal to 0.80 or with significant arterial stenosis on angiography
1.3. Documented cerebrovascular disease: history of previous ischaemic stroke
1.4. Diabetes mellitus with greater than or equal to one additional major CV risk factor(s)
2. Provision of informed consent
3. Adequate baseline carotid US examination
1. Current use of folic acid supplements greater than 200 mg/day
2. Known previous adverse reactions to folic acid, vitamin B6 or B12
3. Planned cardiac, peripheral or cerebrovascular surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method