Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005482
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
2000-05-25
Brief Title:
HomocysteIne Vitamin Status and CVD Risk
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To test the hypotheses that the risk of myocardial infarction andor stroke is associated with elevated plasma levels of homocysteine and low plasma levels of folate vitamins B12 and B6
Detailed Description:
BACKGROUND
Elevated plasma homocysteine 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 homocysteine levels There is also evidence from in vitro studies that the adverse atherogenic or thrombotic effects of Lpa may be greatly enhanced by homocysteine 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 Lpa 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 andor 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 Lpa interacted to increase substantially the risk of myocardial infarction andor 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 Lpa were determined at baseline Results of these assays were combined with other CHS data to address the hypothesis that the risk of myocardial infarction andor stroke was associated with elevated plasma levels of homocysteine and low plasma levels of folate vitamins B12 and B6
Elevated plasma homocysteine 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 homocysteine levels There is also evidence from in vitro studies that the adverse atherogenic or thrombotic effects of Lpa may be greatly enhanced by homocysteine 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 Lpa 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 andor 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 Lpa interacted to increase substantially the risk of myocardial infarction andor 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 Lpa were determined at baseline Results of these assays were combined with other CHS data to address the hypothesis that the risk of myocardial infarction andor stroke was associated with elevated plasma levels of homocysteine and low plasma levels of folate vitamins B12 and B6
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL054711 | NIH | None | httpsreporternihgovquickSearchR01HL054711 |