Cardiovascular DiseasesNCT00005482
Homocyst(e)Ine, Vitamin Status, and CVD Risk
An observational study of Cardiovascular Diseases and Cerebrovascular Accident, run by University of Washington.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Cerebrovascular Accident, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1995to Mar 1999
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Cerebrovascular Accident, Coronary Disease, Myocardial Infarction, Heart Diseases, Hyperhomocysteinemia
- Medical subject headings
- Cardiovascular Diseases, Stroke, Coronary Disease, Myocardial Infarction, Heart Diseases, Hyperhomocysteinemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1995
- Study completionMar 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005482
- Sponsor's protocol ID
- 4969
- Other IDs
- R01HL054711
- Status last verified
- Jun 2000
- First submitted
- 25 May 2000
- Last updated
- 10 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homocyst(e)Ine, Vitamin Status, and CVD Risk
- ClinicalTrials.gov ID
- NCT00005482
- Acronym / sponsor ID
- 4969
- Conditions
- Cardiovascular Diseases, Cerebrovascular Accident, Coronary Disease, Myocardial Infarction, Heart Diseases, Hyperhomocysteinemia
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 1995
- Study completion
- Mar 1999
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cerebrovascular Accident, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2016.