Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)
1. To evaluate whether combined therapy with folic acid 2.5 mg/day, vitamin B6 50 mg/day and vitamin B12 1000 micrograms/day vs placebo reduces the rate of atherosclerosis progression, as evaluated by quantitative B-mode carotid ultrasound (US).
Drug: Vitamins: Folic acid, B6, B12
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Prevention
|Official Title:||Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)|
- The change over time (annualized progression slope) in the mean maximum IMT (the mean maximum IMT slope) defined as the average of the maximum IMT across the 12 preselected carotid arterial segments.
- The change over time (annualized progression slope) in the single maximum IMT amongst any of the same preselected carotid artery segments, i.e. the hemodynamically most important lesson.
|Study Start Date:||January 2000|
|Estimated Study Completion Date:||October 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217178
|Hamilton Health Sciences Corp.|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Eva M Lonn, MD MSc FRCPC FACC||McMaster University|