Cardiovascular DiseasesNCT00005139
Characterization Of Coronary Prone Pedigrees
An observational study of Cardiovascular Diseases and Coronary Disease, run by University of Utah.
Trial summary
To determine the genetics and epidemiology of different types of early familial coronary disease. Accurate markers of major gene syndromes for early coronary disease were identified using a genetic segregation and linkage study of lipids, lipoproteins, apolipoproteins, and DNA probes in 36 large Utah pedigrees. 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
- Jul 1977to Dec 1991
- 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 determine the genetics and epidemiology of different types of early familial coronary disease. Accurate markers of major gene syndromes for early coronary disease were identified using a genetic segregation and linkage study of lipids, lipoproteins, apolipoproteins, and DNA probes in 36 large Utah pedigrees.
Read the detailed description
BACKGROUND:
Heart disease, with coronary heart disease as the main form, and stroke are respectively the first and third most common causes of death in the Unites States. Hypertension, diabetes, hyperlipidemia, and cigarette smoking have been demonstrated to be major risk factors for coronary heart disease and stroke. The first three risk factors have all been suggested to be determined in some degree by genetic factors.
In 1975 the National Heart and Lung Institute convened a Task Force on Genetic Factors in Atherosclerotic Disease to review what was known in the field and to identify fruitful research priorities for future study. The Task Force recommended utilizing existing genealogical files, sampling and studying large kindreds from a general population, evaluating both genetic and modifying factors, and encouraging collaborative studies by epidemiologists, biostatisticians and population geneticists.
The Utah population was well suited for a study of coronary prone pedigrees. The high birth rate and polygamy in ancestral founders of the state produced very large pedigrees. Pedigrees were relatively easy to find and trace with available genealogical records.
DESIGN NARRATIVE:
A computer data base of Utah residents was developed which included 1.2 million persons in genealogical files, 240,000 persons in death certificate files and 120,000 persons in Health Family Tree questionnaire files. Over 1,400 persons who were members of 21 coronary prone pedigrees were clinically screened.
Death certificate files were used to identify early coronary deaths which were defined as before age 55 in men and before age 65 in women. Mail and phone contacts were made to the surviving offspring, spouses, or siblings of the deceased proband to determine risk factor profiles for probands and close relatives. Hospital charts were also abstracted to assess risk factor profiles for probands. Clinical screening of the relatives of coronary probands were conducted using a detailed protocol assessing all standard coronary risk factors. Fasting blood tests were obtained for total cholesterol, triglycerides, high density lipoprotein, apo B, apo A-1, and apo E. At clinical screening, information was obtained on relationships, dates and places of vital events for the index person, spouse, offspring, siblings, parents, aunts and uncles, grandparents, grand aunts and uncles, and great-grandparents. Information was obtained on blood pressure, height, weight, electrocardiograms, physician's history and physical examination. Information was also collected on tobacco and alcohol use, hospitalization, medication usage, socioeconomic status, Type A personality, physical activity, and reproductive history.
Beginning in 1983 the investigators expanded the collection of computerized detailed family histories from the families of high school students participating in the Health Family Trees, a required health education course. Using the Health Family Trees, siblings were identified in which two or more siblings had early coronary heart disease. The information from the Health Family Trees was validated by contacting affected relatives and by collecting hospital data. These individuals then attended clinic screening. Detailed biochemical analyses of blood samples from these individuals were compared to find abnormalities that occured in both siblings with coronary heart disease and to identify specific subtypes of inherited early coronary disease. Testing for genetic linkage of DNA markers for apolipoproteins with these specific abnormalities was also done. Healthy age-sex matched controls with at least three siblings and no coronary heart disease in siblings or parents served as controls.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
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 startJul 1977
- Study completionDec 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (55)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 University of UtahThe 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 Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005139
- Sponsor's protocol ID
- 1010
- Other IDs
- R01HL021088
- Status last verified
- Jan 2016
- First submitted
- 25 May 2000
- Last updated
- 21 Jan 2016
- Results posted
- No
Publications
Lyon JL, Wetzler HP, Gardner JW, Klauber MR, Williams RR. Cardiovascular mortality in Mormons and non-Mormons in Utah, 1969--1971. Am J Epidemiol. 1978 Nov;108(5):357-66. doi: 10.1093/oxfordjournals.aje.a112632.
PubMed 727204Karlin S, Carmelli D, Williams R. Index measures for assessing the mode of inheritance of continuously distributed traits: I, theory and justifications. Theor Popul Biol. 1979 Aug;16(1):81-106. doi: 10.1016/0040-5809(79)90007-8. No abstract available.
PubMed 531766Williams RR, Skolnick M, Carmelli D, Maness AT, Hunt SC, Hasstedt S, Reiber GE, Jones RK. Utah pedigree studies: design and preliminary data for premature male CHD deaths. Prog Clin Biol Res. 1979;32:711-29. No abstract available.
PubMed 523491Carmelli D, Karlin S, Williams RR. A class of indices to assess major-gene versus polygenic inheritance of distributive variables. Prog Clin Biol Res. 1979;32:259-70. No abstract available.
PubMed 523472Williams RR, Lyon JL, Brookert JE, Maness AT: Decline in Coronary Mortality Rates: Utah vs. United States. In: Proceedings of NHLBI Conference on Decline of Coronary Heart Disease Mortality (Havlik RJ, Feinlieb M, Eds). NIH Publ. No 79-16-10, p 48-57, 1979
Williams RR: The Role of Genes in Coronary Atherosclerosis. In: Update IV: The Heart. (Hurst JW, Ed). New York: McGraw Hill, pp 89-118, 1979
Williams RR: A Population Perspective for Early and Familial Coronary Heart Disease. In: Banbury Report 4: Proceedings of Conference on Human Health Data From Defined Populations. New York: Cold Spring Harbor Laboratory, pp 333-350, 1980
Williams RR: What is Your Genetic Risk of An Early Heart Attack? Executive Health, 16:1-8, 1980
Hopkins PN, Williams RR. A survey of 246 suggested coronary risk factors. Atherosclerosis. 1981 Aug-Sep;40(1):1-52. doi: 10.1016/0021-9150(81)90122-2. No abstract available.
PubMed 7025843Hopkins PN, Williams RR. A simplified approach to lipoprotein kinetics and factors affecting serum cholesterol and triglyceride concentrations. Am J Clin Nutr. 1981 Nov;34(11):2560-90. doi: 10.1093/ajcn/34.11.2560.
PubMed 7030050Carmelli D, Williams RR, Rissanen A. Contrasting patterns of familiality for cholesterol and triglyceride in Finland according to type of coronary manifestations and locations. Am J Epidemiol. 1982 Oct;116(4):617-21. doi: 10.1093/oxfordjournals.aje.a113444.
PubMed 7137149Hasstedt SJ, Wilson DE, Edwards CQ, Cannon WN, Carmelli D, Williams RR. The genetics of quantitative plasma Lp(a): analysis of a large pedigree. Am J Med Genet. 1983 Oct;16(2):179-88. doi: 10.1002/ajmg.1320160208.
PubMed 6228142Mason JO, Williams RR, Weber N: Family Health Trees: Targetting Prevention Strategies. Utah State Medical Assoc Bulletin, 31:14-16, 1983
Hasstedt SJ, Albers JJ, Cheung MC, Jorde LB, Wilson DE, Edwards CQ, Cannon WN, Ash KO, Williams RR. The inheritance of high density lipoprotein cholesterol and apolipoproteins A-I and A-II. Atherosclerosis. 1984 Apr;51(1):21-9. doi: 10.1016/0021-9150(84)90141-2.
PubMed 6426485Hopkins PN, Williams RR, Hunt SC. Magnified risks from cigarette smoking for coronary prone families in Utah. West J Med. 1984 Aug;141(2):196-202.
PubMed 6495725
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization Of Coronary Prone Pedigrees
- ClinicalTrials.gov ID
- NCT00005139
- Acronym / sponsor ID
- 1010
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 1977
- Study completion
- Dec 1991
- 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 determine the genetics and epidemiology of different types of early familial coronary disease. Accurate markers of major gene syndromes for early coronary disease were identified using a genetic segregation and linkage study of lipids, lipoproteins, apolipoproteins, and DNA probes in 36 large Utah pedigrees.
Detailed description
BACKGROUND:
Heart disease, with coronary heart disease as the main form, and stroke are respectively the first and third most common causes of death in the Unites States. Hypertension, diabetes, hyperlipidemia, and cigarette smoking have been demonstrated to be major risk factors for coronary heart disease and stroke. The first three risk factors have all been suggested to be determined in some degree by genetic factors.
In 1975 the National Heart and Lung Institute convened a Task Force on Genetic Factors in Atherosclerotic Disease to review what was known in the field and to identify fruitful research priorities for future study. The Task Force recommended utilizing existing genealogical files, sampling and studying large kindreds from a general population, evaluating both genetic and modifying factors, and encouraging collaborative studies by epidemiologists, biostatisticians and population geneticists.
The Utah population was well suited for a study of coronary prone pedigrees. The high birth rate and polygamy in ancestral founders of the state produced very large pedigrees. Pedigrees were relatively easy to find and trace with available genealogical records.
DESIGN NARRATIVE:
A computer data base of Utah residents was developed which included 1.2 million persons in genealogical files, 240,000 persons in death certificate files and 120,000 persons in Health Family Tree questionnaire files. Over 1,400 persons who were members of 21 coronary prone pedigrees were clinically screened.
Death certificate files were used to identify early coronary deaths which were defined as before age 55 in men and before age 65 in women. Mail and phone contacts were made to the surviving offspring, spouses, or siblings of the deceased proband to determine risk factor profiles for probands and close relatives. Hospital charts were also abstracted to assess risk factor profiles for probands. Clinical screening of the relatives of coronary probands were conducted using a detailed protocol assessing all standard coronary risk factors. Fasting blood tests were obtained for total cholesterol, triglycerides, high density lipoprotein, apo B, apo A-1, and apo E. At clinical screening, information was obtained on relationships, dates and places of vital events for the index person, spouse, offspring, siblings, parents, aunts and uncles, grandparents, grand aunts and uncles, and great-grandparents. Information was obtained on blood pressure, height, weight, electrocardiograms, physician's history and physical examination. Information was also collected on tobacco and alcohol use, hospitalization, medication usage, socioeconomic status, Type A personality, physical activity, and reproductive history.
Beginning in 1983 the investigators expanded the collection of computerized detailed family histories from the families of high school students participating in the Health Family Trees, a required health education course. Using the Health Family Trees, siblings were identified in which two or more siblings had early coronary heart disease. The information from the Health Family Trees was validated by contacting affected relatives and by collecting hospital data. These individuals then attended clinic screening. Detailed biochemical analyses of blood samples from these individuals were compared to find abnormalities that occured in both siblings with coronary heart disease and to identify specific subtypes of inherited early coronary disease. Testing for genetic linkage of DNA markers for apolipoproteins with these specific abnormalities was also done. Healthy age-sex matched controls with at least three siblings and no coronary heart disease in siblings or parents served as controls.
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 21 Jan 2016.
- Background: PubMed 727204Lyon JL, Wetzler HP, Gardner JW, Klauber MR, Williams RR. Cardiovascular mortality in Mormons and non-Mormons in Utah, 1969--1971. Am J Epidemiol. 1978 Nov;108(5):357-66. doi: 10.1093/oxfordjournals.aje.a112632.
- Background: PubMed 531766Karlin S, Carmelli D, Williams R. Index measures for assessing the mode of inheritance of continuously distributed traits: I, theory and justifications. Theor Popul Biol. 1979 Aug;16(1):81-106. doi: 10.1016/0040-5809(79)90007-8. No abstract available.
- Background: PubMed 523491Williams RR, Skolnick M, Carmelli D, Maness AT, Hunt SC, Hasstedt S, Reiber GE, Jones RK. Utah pedigree studies: design and preliminary data for premature male CHD deaths. Prog Clin Biol Res. 1979;32:711-29. No abstract available.
- Background: PubMed 523472Carmelli D, Karlin S, Williams RR. A class of indices to assess major-gene versus polygenic inheritance of distributive variables. Prog Clin Biol Res. 1979;32:259-70. No abstract available.
- BackgroundWilliams RR, Lyon JL, Brookert JE, Maness AT: Decline in Coronary Mortality Rates: Utah vs. United States. In: Proceedings of NHLBI Conference on Decline of Coronary Heart Disease Mortality (Havlik RJ, Feinlieb M, Eds). NIH Publ. No 79-16-10, p 48-57, 1979
- BackgroundWilliams RR: The Role of Genes in Coronary Atherosclerosis. In: Update IV: The Heart. (Hurst JW, Ed). New York: McGraw Hill, pp 89-118, 1979
- BackgroundWilliams RR: A Population Perspective for Early and Familial Coronary Heart Disease. In: Banbury Report 4: Proceedings of Conference on Human Health Data From Defined Populations. New York: Cold Spring Harbor Laboratory, pp 333-350, 1980
- BackgroundWilliams RR: What is Your Genetic Risk of An Early Heart Attack? Executive Health, 16:1-8, 1980
- Background: PubMed 7025843Hopkins PN, Williams RR. A survey of 246 suggested coronary risk factors. Atherosclerosis. 1981 Aug-Sep;40(1):1-52. doi: 10.1016/0021-9150(81)90122-2. No abstract available.
- Background: PubMed 7030050Hopkins PN, Williams RR. A simplified approach to lipoprotein kinetics and factors affecting serum cholesterol and triglyceride concentrations. Am J Clin Nutr. 1981 Nov;34(11):2560-90. doi: 10.1093/ajcn/34.11.2560.
- Background: PubMed 7137149Carmelli D, Williams RR, Rissanen A. Contrasting patterns of familiality for cholesterol and triglyceride in Finland according to type of coronary manifestations and locations. Am J Epidemiol. 1982 Oct;116(4):617-21. doi: 10.1093/oxfordjournals.aje.a113444.
- Background: PubMed 6228142Hasstedt SJ, Wilson DE, Edwards CQ, Cannon WN, Carmelli D, Williams RR. The genetics of quantitative plasma Lp(a): analysis of a large pedigree. Am J Med Genet. 1983 Oct;16(2):179-88. doi: 10.1002/ajmg.1320160208.
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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 University of Utah.
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 21 Jan 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 NCT00005139, which also lists 55 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 21 Jan 2016.