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Homocysteine and Progression of Atherosclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005338
First Posted: May 26, 2000
Last Update Posted: February 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
In the first phase, to establish the relationship of progression of peripheral vascular disease (PVD) to plasma homocysteine. In the second phase, to conduct a randomized, controlled trial of folic acid treatment of plasma homocysteine in peripheral vascular disease.

Condition
Cardiovascular Diseases Peripheral Vascular Diseases Atherosclerosis Cerebrovascular Disorders Myocardial Infarction Heart Diseases Hyperhomocysteinemia

Study Type: Observational
Study Design: Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: August 1991
Study Completion Date: August 2004
Detailed Description:

BACKGROUND:

Few studies of progression of atherosclerotic peripheral vascular disease have been performed and none have used objective methods to evaluate disease progression in a large number of symptomatic subjects. The study is of obvious major clinical importance. Elevated plasma homocysteine is well established as an independent risk factor for atherosclerosis. If folate treatment results in less frequent/rapid progression of peripheral vascular disease, then it will be confirmed as the first effective treatment for atherosclerosis which is without toxic side effects and does not involve major changes in life/dietary habits.

DESIGN NARRATIVE:

The Homocysteine and Progression of Atherosclerosis Study (HPAS) is a long term, prospective, blinded, multifactoral clinical study which began in 1991 to study the relationship between elevated plasma homocysteine (HC) as well as a number of other risk factors and PVD progression. The study is divided into two phases, conducted sequentially upon 400 patients with symptomatic lower extremity (LED) and cerebrovascular disease (CVD). The first phase was a three year natural history study in which relationship of progression of peripheral vascular disease to plasma homocysteine and other risk factors was established. The clinical question addressed by the natural history study was: Do patients with symptomatic peripheral vascular disease and elevated plasma homocysteine have more rapid/frequent progression of peripheral vascular disease than patients with symptomatic peripheral vascular disease and normal plasma homocysteine? Progression of disease was assessed by the primary outcome variables of ankle brachial pressure index and degree of carotid artery stenosis, as determined in the noninvasive vascular laboratory, and by secondary outcome variables including vascular death, need for vascular surgery, stroke, myocardial infarction, amputation, and other clinical events. All outcome variables were determined by investigators blinded to the results of plasma homocysteine testing.

The second phase of the study, which began in August, 1995, is a blinded, prospective, randomized, placebo-controlled trial of folic acid treatment of elevated plasma homocysteine in the same patient population. Folic acid treatment has been demonstrated to result in normalization of elevated plasma homocysteine. The treatment trial addresses the clinical question: Do patients with symptomatic peripheral vascular disease and elevated plasma homocysteine treated with folate have less frequent/rapid progression of peripheral vascular disease than patients with symptomatic peripheral vascular disease and elevated plasma homocysteine treated with placebo? Although the second phase is described as a clinical trial, the Surgery and Bioengineering Study Section describes it as clinical research, not an NIH-defined Phase III trial.

The study was renewed in FY 1999 through 2003 to continue follow-up and analysis.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
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): NCT00005338


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Lloyd Taylor Oregon Health and Science University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005338     History of Changes
Other Study ID Numbers: 4200
R01HL045267 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: February 18, 2016
Last Verified: December 2004

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Atherosclerosis
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cerebrovascular Disorders
Hyperhomocysteinemia
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders