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Homocyst(e)Ine, Vitamin Status, and CVD Risk

This study has been completed.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005482
  Purpose

To test the hypotheses that the risk of myocardial infarction and/or stroke is associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins B12 and B6.


Condition
Cardiovascular Diseases
Cerebrovascular Accident
Coronary Disease
Myocardial Infarction
Heart Diseases
Hyperhomocysteinemia

Genetics Home Reference related topics:   argininosuccinic aciduria    citrullinemia    N-acetylglutamate synthase deficiency    ornithine translocase deficiency   

MedlinePlus related topics:   Heart Attack    Heart Diseases   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History

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

Study Start Date:   September 1995
Estimated Study Completion Date:   March 1999

Detailed Description:

BACKGROUND:

Elevated plasma homocyst(e)ine is a risk factor for vascular disease in middle-aged men. Supplementation with folate, and to some extent vitamins B12 and B6, can reduce plasma homocyst(e)ine levels. There is also evidence from in vitro studies that the adverse atherogenic or thrombotic effects of Lp(a) may be greatly enhanced by homocyst(e)ine. The high prevalence of low levels of folate and vitamins B12 and B6 among the elderly in the United States has led to the hypothesis that a substantial portion of cardiovascular morbidity and mortality among older persons could be prevented by increasing intake of these nutrients to reduce plasma levels of homocysteine. Little is known, however, regarding the relationship of homocysteine, folate, B vitamins, and Lp(a) to cardiovascular disease among the elderly, among whom CVD represents the leading cause of morbidity and mortality.

DESIGN NARRATIVE:

In this ancillary study to the prospective Cardiovascular Health Study (CHS), a case-cohort design was used to test hypotheses that the risk of myocardial infarction and/or stoke was associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins B12 and B6. Further, a determination was made whether elevated plasma levels of homocysteine and Lp(a) interacted to increase substantially the risk of myocardial infarction and/or stroke above that due to either factor alone. The sub-cohort was used to study the relationship between the factors under study and progression of sub-clinical atherosclerosis. For each case and sub-cohort member, an aliquot of fasting plasma drawn at baseline was analyzed for homocysteine, folate B12, and B6 concentrations. [Values of plasma Lp(a) were determined at baseline.] Results of these assays were combined with other CHS data to address the hypothesis that the risk of myocardial infarction and/or stroke was associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins B12 and B6.

  Eligibility
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

No eligibility criteria

  Contacts and Locations

No Contacts or Locations Provided
  More Information


Study ID Numbers:   4969
First Received:   May 25, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00005482
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Metabolic Diseases
Heart Diseases
Cerebral Infarction
Hyperhomocysteinemia
Amino Acid Metabolism, Inborn Errors
Myocardial Ischemia
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders
Coronary Disease
Metabolism, Inborn Errors
Inborn amino acid metabolism disorder
Necrosis
Genetic Diseases, Inborn
Brain Ischemia
Brain Infarction
Metabolic disorder
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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