Back to resultsHomocysteine Lowering and Atherosclerosis Reduction Trial (HART)
Primary Purpose
Atherosclerosis, Cardiovascular Disease
Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Vitamins: Folic acid, B6, B12
Sponsored by
About this trial
This is an interventional prevention trial for Atherosclerosis focused on measuring Atherosclerosis, CV Risk Factors, Homocysteine, CV disease, Cardiovascular disease
Eligibility Criteria
Inclusion Criteria:Women and Men aged ≥ 55 years at high risk for CV events with: (a) Documented (CAD): i) History of prior MI; ii) stable or unstable angina with documented multivessel CAD or strongly positive stress test; iii) Multivessel CAD and PTCA ≥ 6 months prior to randomization; iv) multivessel CABG ≥ 4 years prior to randomization; v) Multivessel CAD on angiography; (b) Documented peripheral vascular disease (PVD): i) Previous limp bypass surgery and/or previous peripheral percutaneous transluminal angioplasty and/or previous limp or foot amputation due to PVD.ii) History of intermittent claudication with ankle/arm blood pressure ratio of ≤ 0.80 or with significant arterial stenosis on angiography; (c) Documented cerebrovascular disease: i) History of previous ischemic stroke; and (d) Diabetes mellitus with ≥ 1 additional major CV risk factor(s). (2) Provision of informed consent.(3) Adequate baseline carotid US examination. Exclusion Criteria:1. Current use of folic acid supplements > 200 mg/day. 2. Known previous adverse reactions to folic acid, Vitamin B6 or B12. 3. Planned cardiac, peripheral or cerebrovascular. -
Sites / Locations
- Hamilton Health Sciences Corp.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00217178
First Posted
September 16, 2005
Last Updated
September 16, 2005
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Canadian Institutes of Health Research (CIHR), Population Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00217178
Brief Title
Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)
Official Title
Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2004
Overall Recruitment Status
Unknown status
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
Canadian Institutes of Health Research (CIHR), Population Health Research Institute
4. Oversight
5. Study Description
Brief Summary
Study Objective:
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).
Detailed Description
The HART study is designed as a substudy of the Heart Outcomes Prevention Evaluation-2 (HOPE-2)trial which evaluates the effect of combined therapy ? folic acid and vitamin B6 and B12 on clinical events. The study is designed to enrol 900 study participants randomized to homocysteine lowering therapies or placebo. Follow-up will estimate over 5 years. Study participants will undergo yearly carotid B-Mode ultrasound examinations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Cardiovascular Disease
Keywords
Atherosclerosis, CV Risk Factors, Homocysteine, CV disease, Cardiovascular disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
900 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vitamins: Folic acid, B6, B12
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Women and Men aged ≥ 55 years at high risk for CV events with: (a) Documented (CAD): i) History of prior MI; ii) stable or unstable angina with documented multivessel CAD or strongly positive stress test; iii) Multivessel CAD and PTCA ≥ 6 months prior to randomization; iv) multivessel CABG ≥ 4 years prior to randomization; v) Multivessel CAD on angiography; (b) Documented peripheral vascular disease (PVD): i) Previous limp bypass surgery and/or previous peripheral percutaneous transluminal angioplasty and/or previous limp or foot amputation due to PVD.ii) History of intermittent claudication with ankle/arm blood pressure ratio of ≤ 0.80 or with significant arterial stenosis on angiography; (c) Documented cerebrovascular disease: i) History of previous ischemic stroke; and (d) Diabetes mellitus with ≥ 1 additional major CV risk factor(s). (2) Provision of informed consent.(3) Adequate baseline carotid US examination.
Exclusion Criteria:1. Current use of folic acid supplements > 200 mg/day. 2. Known previous adverse reactions to folic acid, Vitamin B6 or B12. 3. Planned cardiac, peripheral or cerebrovascular.
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Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva M Lonn, MD MSc FRCPC FACC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences Corp.
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
18940900
Citation
Held C, Sumner G, Sheridan P, McQueen M, Smith S, Dagenais G, Yusuf S, Lonn E. Correlations between plasma homocysteine and folate concentrations and carotid atherosclerosis in high-risk individuals: baseline data from the Homocysteine and Atherosclerosis Reduction Trial (HART). Vasc Med. 2008 Nov;13(4):245-53. doi: 10.1177/1358863X08092102.
Results Reference
derived
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Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)
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