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Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)

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ClinicalTrials.gov Identifier: NCT00217178
Recruitment Status : Unknown
Verified October 2004 by McMaster University.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Population Health Research Institute
Information provided by:
McMaster University

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).


Condition or disease Intervention/treatment Phase
Atherosclerosis Cardiovascular Disease Drug: Vitamins: Folic acid, B6, B12 Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)
Study Start Date : January 2000
Estimated Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Folic acid
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00217178


Locations
Canada, Ontario
Hamilton Health Sciences Corp.
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Population Health Research Institute
Investigators
Principal Investigator: Eva M Lonn, MD MSc FRCPC FACC McMaster University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00217178     History of Changes
Other Study ID Numbers: HART, CIHR Grant # MCT 44159
CIHR, MCT 44159
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: October 2004

Keywords provided by McMaster University:
Atherosclerosis
CV Risk Factors
Homocysteine
CV disease
Cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Folic Acid
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs