Cardiovascular DiseasesNCT00005184
Immunogenetic Factors of Coronary Heart Disease
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To assess the association of immunogenetic factors with onset of coronary heart disease and the interrelationship of these factors with standard coronary heart disease risk factors. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 1985to Nov 1989
- 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 assess the association of immunogenetic factors with onset of coronary heart disease and the interrelationship of these factors with standard coronary heart disease risk factors.
Read the detailed description
BACKGROUND:
Although the familial clustering of coronary heart disease has been well documented, it is unclear as to whether the familial clustering can be explained by shared environmental factors by members of a family or by clustering of risk factors having a genetic component such as blood pressure, familial hyperlipidemia and/or diabetes. Studies indicate that a family history of coronary disease may be an independent risk factor. Major histocompatibility complex genetic markers to identify individuals at risk within a family may be useful. In 1985 when the study began, there was a paucity of data dealing with the interrelationship of family history, genetic markers, immunological markers, and traditional risk factors.
DESIGN NARRATIVE:
In this case-control study, the study population consisted of incident cases who presented to the Georgia Heart Clinic in La Grange, Georgia with coronary heart disease. The majority of the subjects were from three counties in mideastern Alabama and from counties in midwestern Georgia. All subjects had undergone diagnostic coronary angiography. A determination was made in patients and controls of the association of major histocompatibility complex genetic markers HLA-A, -B, -C, -DR, C4 and BF, C3, the restriction fragment length polymorphisms (RFLP's) flanking the apolipoprotein AI and insulin genes, presence of autoantibodies, and family history of coronary disease, diabetes, or hypothyroidism. The frequency of these variables was compared with the standard coronary risk factors of family history, hypertension, lipid abnormalities, lifestyle, Type A behavior, obesity and with diseases such as diabetes and hypothyroidism. An analysis was made of the strength of these variables for predicting those individuals at risk and whether there were variables which predict severity of disease based on 1, 2, or 3 vessel involvement.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Hypertension, Obesity, Diabetes Mellitus
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Hypertension, Obesity, Diabetes Mellitus, Hypothyroidism
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 startDec 1985
- Study completionNov 1989
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005184
- Sponsor's protocol ID
- 1062
- Other IDs
- R01HL033959
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Go R, Acton R, Roseman J, Barger B, Perkins L, Vanichanan T, Moore P, Brand J, Gore T, Brennan J, Cousins L, Copeland R: Immunogenetic Risk Factors for Premature Coronary Artery Disease in Southeastern USA Population. Genome, 30:34, 1988
Acton R, Bamberg R, Go R, Roseman J: Utilization of Genetic and Other Laboratory Test Results to Predict and Reduce the Risk of Disease. In: Proceedings of the Society of Prospective Medicine, 1988. 1988.
Bamberg R, Copeland R, Barger B, Roseman J, Go R, Vanichanan C, Brand J, Moore P, Acton R: Genetic Risk Information as an Impetus to Health Related Behavioral Change. In: Proceedings of the Society of Prospective Medicine, 1988. 1988.
Pancharuniti N, Lewis CA, Sauberlich HE, Perkins LL, Go RC, Alvarez JO, Macaluso M, Acton RT, Copeland RB, Cousins AL, et al. Plasma homocyst(e)ine, folate, and vitamin B-12 concentrations and risk for early-onset coronary artery disease. Am J Clin Nutr. 1994 Apr;59(4):940-8. doi: 10.1093/ajcn/59.4.940.
PubMed 8147342
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenetic Factors of Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00005184
- Acronym / sponsor ID
- 1062
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Hypertension, Obesity, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Dec 1985
- Study completion
- Nov 1989 (actual)
- 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 assess the association of immunogenetic factors with onset of coronary heart disease and the interrelationship of these factors with standard coronary heart disease risk factors.
Detailed description
BACKGROUND:
Although the familial clustering of coronary heart disease has been well documented, it is unclear as to whether the familial clustering can be explained by shared environmental factors by members of a family or by clustering of risk factors having a genetic component such as blood pressure, familial hyperlipidemia and/or diabetes. Studies indicate that a family history of coronary disease may be an independent risk factor. Major histocompatibility complex genetic markers to identify individuals at risk within a family may be useful. In 1985 when the study began, there was a paucity of data dealing with the interrelationship of family history, genetic markers, immunological markers, and traditional risk factors.
DESIGN NARRATIVE:
In this case-control study, the study population consisted of incident cases who presented to the Georgia Heart Clinic in La Grange, Georgia with coronary heart disease. The majority of the subjects were from three counties in mideastern Alabama and from counties in midwestern Georgia. All subjects had undergone diagnostic coronary angiography. A determination was made in patients and controls of the association of major histocompatibility complex genetic markers HLA-A, -B, -C, -DR, C4 and BF, C3, the restriction fragment length polymorphisms (RFLP's) flanking the apolipoprotein AI and insulin genes, presence of autoantibodies, and family history of coronary disease, diabetes, or hypothyroidism. The frequency of these variables was compared with the standard coronary risk factors of family history, hypertension, lipid abnormalities, lifestyle, Type A behavior, obesity and with diseases such as diabetes and hypothyroidism. An analysis was made of the strength of these variables for predicting those individuals at risk and whether there were variables which predict severity of disease based on 1, 2, or 3 vessel involvement.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
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 13 May 2016.
- BackgroundGo R, Acton R, Roseman J, Barger B, Perkins L, Vanichanan T, Moore P, Brand J, Gore T, Brennan J, Cousins L, Copeland R: Immunogenetic Risk Factors for Premature Coronary Artery Disease in Southeastern USA Population. Genome, 30:34, 1988
- BackgroundActon R, Bamberg R, Go R, Roseman J: Utilization of Genetic and Other Laboratory Test Results to Predict and Reduce the Risk of Disease. In: Proceedings of the Society of Prospective Medicine, 1988. 1988.
- BackgroundBamberg R, Copeland R, Barger B, Roseman J, Go R, Vanichanan C, Brand J, Moore P, Acton R: Genetic Risk Information as an Impetus to Health Related Behavioral Change. In: Proceedings of the Society of Prospective Medicine, 1988. 1988.
- Background: PubMed 8147342Pancharuniti N, Lewis CA, Sauberlich HE, Perkins LL, Go RC, Alvarez JO, Macaluso M, Acton RT, Copeland RB, Cousins AL, et al. Plasma homocyst(e)ine, folate, and vitamin B-12 concentrations and risk for early-onset coronary artery disease. Am J Clin Nutr. 1994 Apr;59(4):940-8. doi: 10.1093/ajcn/59.4.940.
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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 Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
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 13 May 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?
On the ClinicalTrials.gov record for NCT00005184, which also lists 4 linked publications.
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 13 May 2016.