This study is NOT currently recruiting participants.
Number
14-HG-0048
Sponsoring Institute
National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 21 Years Max Age: 65 Years
Referral Letter Required
No
Population Exclusion(s)
Children;American Indian or Alaskan Native;Asian;White;Native Hawaiian/Pacific Islander;Non-English Speaking
Keywords
African American; Natural History
Recruitment Keyword(s)
None
Condition(s)
Hypertension
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Heart, Lung, and Blood Institute
The primary outcome variables involve well established CVD phenotypes: 1) CVD risk factors (e.g. hypertension, dyslipidemia), 2) markers of pre-clinical CVD (i.e. coronary artery calcification, coronary plaque burden by cardiac CT angiography (CTA), carotid plaque burden by 3D ultrasound, vascular dysfunction, microalbuminuria, C-reactive protein, Vitamin D levels). The protocol will assess exposures associated with CVD and relevant covariates including: 1) social determinants (e.g. socioeconomic status (SES), perceived stress, discrimination, and depression); 2) environmental factors such as neighborhood characteristics (geospatial features of healthy lifestyles [e.g. walkability]) and 3) behavioral factors (e.g. diet, physical activity). The G2P callback visit protocol will involve additional measures of in-depth phenotyping that include: 1) peripheral immune cell phenotyping (e.g. T-cell, monocyte subsets); 2) blood/immune cell RNAseq; 3) iPSC cell line generation (endothelial; vascular smooth muscle cells) and analysis of cardiovascular cell systems biology; 4) HDL proteome analysis, 5) FDG PET/CT and/or PET/MRI scan (vascular inflammation) 6) echocardiography, 7) bisulfite sequencing for identifying sites of DNA methylation, and 8) chromatin immunoprecipitation followed by sequencing (Chip-Seq) for identifying sites of histone modification. It is anticipated that this multi-level, multi-dimensional analysis of genomic and phenotypic characteristics of AA will advance our understanding of the bio-social determinants of the intragroup variance and the increased overall burde...
--Back to Top--
INCLUSION CRITERIA: Community-based self-identified (non-institutionalized), US-born, African American men and women age 21-65 will be included in the study. This criterion is inclusive of self-identified AA of both Hispanic and non-Hispanic ethnicity. EXCLUSION CRITERIA: Pregnant women are excluded from all aspects of the protocol. Adults who are unable to provide informed consent will be excluded. There are various reasons for excluding pregnant women from all protocol activities. It is well established that many of the primary and secondary study outcome variables and covariates being assessed by the protocol are significantly influenced by the pregnant state. For example pregnancy is known to affect multiple key study variables such as: blood pressure, endothelial function, vascular compliance/stiffness, body mass index, glucose-insulin metabolism and various neurohumoral factors involved in cardiovascular homeostasis. Similarly, pregnancy may have a confounding effect on important behavioral and psycho-social parameters under study (e.g. diet, sleep habits, physical activity, perceived stress, depression). Moreover, it is anticipated that a long-term objective of the study is to "call-back" many GENE-FORECAST participants for either follow-up and/or serial, longitudinal assessments of certain key parameters. It is therefore essential that the initial baseline evaluation not involve a transient condition such as pregnancy that has such profound effects on the cardio-metabolic phenotype under study. Neonates are excluded because they are less than the age of 21 years. Non-English speaking African Americans and those not born in the United States will be excluded. These individuals will be excluded because the exposure to social determinants experienced by African Americans born in the US differs from that of Africans born elsewhere and because the survey instruments in this protocol have only been verified in English speaking African-Americans. Furthermore, African immigrants are likely to have metabolic and cardiovascular profiles that are distinct from African Americans, and this could be a source of uncharacterized confounding factors. Those with severe and disabling co-morbidities associated with end-stage CVD will be excluded such as a recent history of hospitalization for manifestations of cardiovascular disease. More specifically, patients with a history of stroke, heart attack and/or heart failure in the past 12 months will be excluded. Nursing females will be excluded from FGD PET/CT and/or PET/MRI. Participants with pacemakers and/or any history of metal device implantation and/or metal in their body will be excluded from MRI according to clinical center guidelines. Participants with implanted electronic medical device will be excluded from percent body fat measurement. For CTA, patients with known allergic reaction to contrast will not be given contrast. Diabetic patients taking metformin will be excluded from receiving CTA IV contrast agents. Patients with renal failure (eGFR<60) will not be given either MRI or CTA IV contrast. Adults who are or may be unable to consent are excluded due to their lack of knowledge to study components.
Community-based self-identified (non-institutionalized), US-born, African American men and women age 21-65 will be included in the study. This criterion is inclusive of self-identified AA of both Hispanic and non-Hispanic ethnicity.
EXCLUSION CRITERIA:
Pregnant women are excluded from all aspects of the protocol. Adults who are unable to provide informed consent will be excluded. There are various reasons for excluding pregnant women from all protocol activities. It is well established that many of the primary and secondary study outcome variables and covariates being assessed by the protocol are significantly influenced by the pregnant state. For example pregnancy is known to affect multiple key study variables such as: blood pressure, endothelial function, vascular compliance/stiffness, body mass index, glucose-insulin metabolism and various neurohumoral factors involved in cardiovascular homeostasis. Similarly, pregnancy may have a confounding effect on important behavioral and psycho-social parameters under study (e.g. diet, sleep habits, physical activity, perceived stress, depression). Moreover, it is anticipated that a long-term objective of the study is to "call-back" many GENE-FORECAST participants for either follow-up and/or serial, longitudinal assessments of certain key parameters. It is therefore essential that the initial baseline evaluation not involve a transient condition such as pregnancy that has such profound effects on the cardio-metabolic phenotype under study. Neonates are excluded because they are less than the age of 21 years.
Non-English speaking African Americans and those not born in the United States will be excluded. These individuals will be excluded because the exposure to social determinants experienced by African Americans born in the US differs from that of Africans born elsewhere and because the survey instruments in this protocol have only been verified in English speaking African-Americans. Furthermore, African immigrants are likely to have metabolic and cardiovascular profiles that are distinct from African Americans, and this could be a source of uncharacterized confounding factors. Those with severe and disabling co-morbidities associated with end-stage CVD will be excluded such as a recent history of hospitalization for manifestations of cardiovascular disease. More specifically, patients with a history of stroke, heart attack and/or heart failure in the past 12 months will be excluded. Nursing females will be excluded from FGD PET/CT and/or PET/MRI. Participants with pacemakers and/or any history of metal device implantation and/or metal in their body will be excluded from MRI according to clinical center guidelines. Participants with implanted electronic medical device will be excluded from percent body fat measurement. For CTA, patients with known allergic reaction to contrast will not be given contrast. Diabetic patients taking metformin will be excluded from receiving CTA IV contrast agents. Patients with renal failure (eGFR<60) will not be given either MRI or CTA IV contrast. Adults who are or may be unable to consent are excluded due to their lack of knowledge to study components.
Principal Investigator
Referral Contact
For more information: