Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005136
Status:
COMPLETED
Last Update Posted:
2014-03-17
First Post:
2000-05-25
Brief Title:
Family Heart Study FHS
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-03
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 identify and evaluate genetic and non-genetic determinants of coronary heart disease CHD atherosclerosis and their risk factors in ongoing population-based epidemiology studies The multicenter study was conducted in three phases which were Phase I the family history component Phase II the clinical examination and follow-up component and Phase III the molecular genetic and genetic epidemiology studies component
Detailed Description:
BACKGROUND
Advances in molecular genetics genetic epidemiology population genetics and identification of new risk factors and clusters of risk factors for cardiovascular disease made 1991 an opportune time to take advantage of the extensive information about cardiovascular disease pre-clinical atherosclerosis and risk factors in individuals who had been examined in ongoing state-of-the-art epidemiological studies supported by the NHLBI By recruiting first degree relatives of random samples of such defined populations FHS obtained information about familial aggregation genetic and environmental contributions to variance in continuous variables and the frequency and distribution of elevated levels of risk factors and of selected major genes in the general population
The FHS was initiated by staff and approved by the Clinical Applications and Prevention Advisory Commitee in May 1990 The Requests for Proposals were released in July 1991 Contracts were awarded in June 1992
DESIGN NARRATIVE
During Phases I and II from May 1992-May 1996 probands aged 45-69 were recruited from the Framingham Heart Study the Utah Family Tree Study and the North Carolina and Minnesota sites of the ARIC Study along with their relatives for participation in the Family Heart Study Two groups of probands were selected either randomly or by a high family risk of CHD as calculated from data from the parent study Additional family structure and disease history data were collected on 3150 probands and 22909 of their relatives Clinical examination and follow-up of these random and high CHD risk families were conducted on a total of 1253 families including 5975 individuals of whom 102 families including 265 individuals were African-American The examinations included information on anthropometry blood pressure ECG carotid ultrasound pulmonary function and blood chemistries Questionnaire data included medical and reproductive histories diet physical activity tobacco and alcohol consumption education income and psychosocial factors including hostility social support and stress Phases I and II included four field centers a coordinating center and a central blood laboratory
In August 1996 Phase III began when cooperative agreements were awarded to a consortium of seven investigator-initiated grants to conduct molecular genetic and genetic epidemiology studies using data collected during Phases I and II Phase III ended in July 2001 The objective of Phase III was to perform molecular genetic and genetic epidemiology studies using the extensive data on family and medical histories risk factors life style blood specimens and banked DNA previously collected by the FHS Studies included novel molecular genetics of candidate genes and genome-wide searches with anonymous markers for the detection mapping and characterization of coronary heart disease and atherosclerosis genes Genetic epidemiology analyses were conducted that contributed new information on the familial aspects of atherosclerosis and intermediate phenotypes in African Americans Phase III also included four field centers a central laboratory a molecular genetics laboratory and a coordinating center
The study was renewed in 2001 as the Family Heart Study - Subclinical Atherosclerosis Network FHS-SCAN to complete analyses of genome-wide scan data and to genotype promising markers The study expects to enroll 401 informative pedigrees 3027 individuals previously examined and genotyped by the NHLBI Family Heart Study to quantify coronary and aortic calcium volume in order to identify genes associated with atherosclerosis In addition 315 African American sibships 770 individuals previously examined and comparably genotyped by the Hypertension Epidemiology Network HyperGEN will be examined at one study center to address these study questions in this minority population
Advances in molecular genetics genetic epidemiology population genetics and identification of new risk factors and clusters of risk factors for cardiovascular disease made 1991 an opportune time to take advantage of the extensive information about cardiovascular disease pre-clinical atherosclerosis and risk factors in individuals who had been examined in ongoing state-of-the-art epidemiological studies supported by the NHLBI By recruiting first degree relatives of random samples of such defined populations FHS obtained information about familial aggregation genetic and environmental contributions to variance in continuous variables and the frequency and distribution of elevated levels of risk factors and of selected major genes in the general population
The FHS was initiated by staff and approved by the Clinical Applications and Prevention Advisory Commitee in May 1990 The Requests for Proposals were released in July 1991 Contracts were awarded in June 1992
DESIGN NARRATIVE
During Phases I and II from May 1992-May 1996 probands aged 45-69 were recruited from the Framingham Heart Study the Utah Family Tree Study and the North Carolina and Minnesota sites of the ARIC Study along with their relatives for participation in the Family Heart Study Two groups of probands were selected either randomly or by a high family risk of CHD as calculated from data from the parent study Additional family structure and disease history data were collected on 3150 probands and 22909 of their relatives Clinical examination and follow-up of these random and high CHD risk families were conducted on a total of 1253 families including 5975 individuals of whom 102 families including 265 individuals were African-American The examinations included information on anthropometry blood pressure ECG carotid ultrasound pulmonary function and blood chemistries Questionnaire data included medical and reproductive histories diet physical activity tobacco and alcohol consumption education income and psychosocial factors including hostility social support and stress Phases I and II included four field centers a coordinating center and a central blood laboratory
In August 1996 Phase III began when cooperative agreements were awarded to a consortium of seven investigator-initiated grants to conduct molecular genetic and genetic epidemiology studies using data collected during Phases I and II Phase III ended in July 2001 The objective of Phase III was to perform molecular genetic and genetic epidemiology studies using the extensive data on family and medical histories risk factors life style blood specimens and banked DNA previously collected by the FHS Studies included novel molecular genetics of candidate genes and genome-wide searches with anonymous markers for the detection mapping and characterization of coronary heart disease and atherosclerosis genes Genetic epidemiology analyses were conducted that contributed new information on the familial aspects of atherosclerosis and intermediate phenotypes in African Americans Phase III also included four field centers a central laboratory a molecular genetics laboratory and a coordinating center
The study was renewed in 2001 as the Family Heart Study - Subclinical Atherosclerosis Network FHS-SCAN to complete analyses of genome-wide scan data and to genotype promising markers The study expects to enroll 401 informative pedigrees 3027 individuals previously examined and genotyped by the NHLBI Family Heart Study to quantify coronary and aortic calcium volume in order to identify genes associated with atherosclerosis In addition 315 African American sibships 770 individuals previously examined and comparably genotyped by the Hypertension Epidemiology Network HyperGEN will be examined at one study center to address these study questions in this minority population
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 |
|---|---|---|---|
| U01HL056564 | NIH | None | httpsreporternihgovquickSearchU01HL056564 |