Heart DiseaseNCT05484882
Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African-Americans Study (GENE-FORECAST): Prospective COVID-19 Natural History Study
An observational study of Heart Disease, run by National Human Genome Research Institute (NHGRI) at 2 sites in United States.
Trial summary
Background: The COVID-19 pandemic infected and killed African Americans at higher rates than other Americans. Researchers want to understand why. Objective: This natural history study will look at how genetic, environmental, and social factors may predict or affect COVID-19 in African Americans. Read more about this study
- Who is it for?
- Ages 21 to 115 years
- Conditions the study is for
- Heart Disease
- How many people
- 431 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Feb 2023to 26 Jun 2023
- 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 21 to 115 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 650 African American men and women residing in the metropolitan DC area who previously competed baseline activities in the GENE-FORECAST protocol. Participants will be at least 21 years of age.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Self-identified African American men and women who previously enrolled in GENE-FORECAST, completed baseline activities and gave permission for recontact through the GENE-FORECAST protocol.
- Stated willingness to participate in study procedures.
- Ability of subject to understand and the willingness to give verbal informed consent for the CATI and the ability to understand and the willingness to sign a written informed consent document for the clinic visit.
- Individuals eligible for this protocol are previous GENE-FORECAST participants, all of whom are English speakers. Therefore, by default, this study includes only English speakers.
Who cannot join
- Only individuals who completed the baseline protocol of GENE-FORECAST and gave permission for recontact through the GENE-FORECAST protocol will be invited to participate. Among this group, there are no exclusions for this study except those who are pregnant.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Westat, Inc.
Rockville, Maryland, 20850
About this study
Official title: Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African Americans Study (GENEFORECAST): Prospective COVID-19 Natural History Study
Background:
The COVID-19 pandemic infected and killed African Americans at higher rates than other Americans. Researchers want to understand why.
Read more
Objective:
This natural history study will look at how genetic, environmental, and social factors may predict or affect COVID-19 in African Americans. Information from this study will be combined with data from the GENE-FORECAST study.
Eligibility:
African Americans who were previously enrolled in GENE-FORECAST.
Design:
The study includes a telephone interview and 1 visit to the NIH clinic. Participants may engage in either one or both of these activities.
The telephone interview will last 20 minutes. Participants will talk about their experiences during the COVID-19 pandemic.
The clinic visit will last up to 4 hours.
Participants will have a physical exam. They will have blood and urine tests.
They will be tested for COVID-19. A long swab will be inserted into a nostril to get a fluid sample from the back of the nose.
They will have noninvasive tests of their blood vessels. One device used is a pen-like probe placed lightly on the wrist. Another is a rubber sleeve placed around a finger while a blood pressure cuff is used on the arm.
Participants will have a test to measure the electrical activity in their heart. Stickers attached to wires will be placed on their chest, arms, and legs.
Participants will answer more questions about COVID-19. They will talk about their health behavior. They will talk about their family's health and the neighborhood they live in. Other questions will ask how they feel, live, work, and play.
Read the detailed description
STUDY DESCRIPTION
The objective is to conduct a prospective natural history study of Coronavirus disease 2019 (COVID-19) among a community-based cohort of African Americans enrolled in GENE-FORECAST for whom we have comprehensive psychosocial, clinical, and genetic data collected at baseline. Participants will be invited to take part in a 20-minute computer-assisted telephone interview (CATI) on exposures, attitudes and circumstances during the COVID-19 pandemic and to undergo a clinic visit for a physical exam, vascular function tests and biospecimen collection. We will identify social, clinical and genetic risk factors for COVID-19 and examine the interplay between social determinants of health and personal risk profiles to better understand the disparate burden of COVID-19 in the African American community. It is hypothesized that exposure to the SARS-CoV-2 virus and the development of COVID-19 will be associated with social and neighborhood factors, and that SARS-CoV-2 infection will adversely affect vascular function.
OBJECTIVES
Primary Objectives:
- Define the effect of social factors (e.g., socio-economic status; neighborhood characteristics) on exposure to SARS-CoV-2 and the development of COVID-19.
- Define the effect of SARS-CoV-2 infection and the development of COVID-19 on vascular function (e.g., pulse wave velocity).
- Examine how social factors influence the effect of SARS-CoV-2 and COVID-19 on vascular function.
Secondary Objectives:
- Examine the effects of SARS-CoV-2 infection and COVID-19 on epigenome (whole-blood), transcriptome, (whole-blood, plasma microvesicles, urine), peripheral blood mononuclear cell (PBMC) single-cell RNA-seq, biomarker profile (e.g., CRP; d-dimer), cardiac function (EKG) and leukocyte telomere length.
- Examine how social factors influence the effect of SARS-CoV-2 infection and COVID-19 on transcriptome and epigenome.
ENDPOINTS
Primary Endpoints:
SARS-CoV-2 infection
Vascular function (e.g., pulse wave velocity; vascular stiffness indices; reactive hyperemia)
Secondary Endpoints:
Transcriptome (whole-blood, plasma microvesicles, urine)
Epigenome (whole-blood)
PBMC single-cell RNA-seq
Leukocyte telomere length
Electrocardiogram (EKG)
Biomarker profile (CRP, D-Dimer, ACE-2, HS-Troponin)
- Conditions
- Heart Disease
- Keywords
- African-American, Cardiovascular Disease, COVID-19, Natural History
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GENEFORECAST | African American men and women residing in the Washington DC area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the effect of SARS-CoV-2 infection and the development of COVID-19 on vascular function (e.g., pulse wave velocity).
Vascular function (e.g., pulse wave velocity; vascular stiffness indices; reactive hyperemia)
Measured: 48 month
Examine how social factors influence the effect of SARS-CoV-2 and COVID-19 on vascular function.
African Americans are disproportionately affected by SARS-CoV-2 infection and COVID-19. There are well-documented socioeconomic inequalities that contribute to this increased vulnerability. The disparate burden of disease demands a multidimensional approach informed by social determinants of health, geography (neighborhood), and personalized risk profiles. Among the social, environmental, clinical and genetic factors likely to be important for COVID-19 risks and outcomes, there is little understanding of the relative importance of these factors among African Americans and how they interact to affect morbidity and mortality.
Measured: 48 month
Define the effect of social factors (e.g., socio-economic status; neighborhood characteristics) on exposure to SARS-CoV-2 and the development of COVID-19
Vascular function (e.g., pulse wave velocity; vascular stiffness indices; reactive hyperemia)
Measured: 48 month
Secondary outcomes (2)
Examine how social factors influence the effect of SARS-CoV-2 infection and COVID-19 on transcriptome and epigenome.
Biomarker profile (CRP, D-Dimer, ACE-2, HS-Troponin) * Analyses of all of the above endpoints will use change in values from baseline GENE-FORECAST to current measures.
Measured: 48 month
Examine the effects of SARS-CoV-2 infection and COVID-19 on epigenome (whole-blood), transcriptome, (whole-blood, plasma microvesicles, urine), peripheral blood mononuclear cell (PBMC) single-cell RNA-seq, biomarker profile (e.g., CRP; d-dimer),...
Transcriptome (whole-blood, plasma microvesicles, urine) Epigenome (whole-blood) PBMC single-cell RNA-seq Leukocyte telomere length
Measured: 48 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start18 Feb 2023
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Laura M Koehly, Ph.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484882
- Sponsor's protocol ID
- 10000577
- Other IDs
- 000577-HG
- Status last verified
- 19 Feb 2026
- First submitted
- 30 Jul 2022
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African Americans Study (GENEFORECAST): Prospective COVID-19 Natural History Study
- ClinicalTrials.gov ID
- NCT05484882
- Acronym / sponsor ID
- 10000577
- Conditions
- Heart Disease
- Keywords
- African-American, Cardiovascular Disease, COVID-19, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 18 Feb 2023 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 2 Aug 2022 (actual)
- 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.
Background:
The COVID-19 pandemic infected and killed African Americans at higher rates than other Americans. Researchers want to understand why.
Objective:
This natural history study will look at how genetic, environmental, and social factors may predict or affect COVID-19 in African Americans. Information from this study will be combined with data from the GENE-FORECAST study.
Eligibility:
African Americans who were previously enrolled in GENE-FORECAST.
Design:
The study includes a telephone interview and 1 visit to the NIH clinic. Participants may engage in either one or both of these activities.
The telephone interview will last 20 minutes. Participants will talk about their experiences during the COVID-19 pandemic.
The clinic visit will last up to 4 hours.
Participants will have a physical exam. They will have blood and urine tests.
They will be tested for COVID-19. A long swab will be inserted into a nostril to get a fluid sample from the back of the nose.
They will have noninvasive tests of their blood vessels. One device used is a pen-like probe placed lightly on the wrist. Another is a rubber sleeve placed around a finger while a blood pressure cuff is used on the arm.
Participants will have a test to measure the electrical activity in their heart. Stickers attached to wires will be placed on their chest, arms, and legs.
Participants will answer more questions about COVID-19. They will talk about their health behavior. They will talk about their family's health and the neighborhood they live in. Other questions will ask how they feel, live, work, and play.
Detailed description
STUDY DESCRIPTION
The objective is to conduct a prospective natural history study of Coronavirus disease 2019 (COVID-19) among a community-based cohort of African Americans enrolled in GENE-FORECAST for whom we have comprehensive psychosocial, clinical, and genetic data collected at baseline. Participants will be invited to take part in a 20-minute computer-assisted telephone interview (CATI) on exposures, attitudes and circumstances during the COVID-19 pandemic and to undergo a clinic visit for a physical exam, vascular function tests and biospecimen collection. We will identify social, clinical and genetic risk factors for COVID-19 and examine the interplay between social determinants of health and personal risk profiles to better understand the disparate burden of COVID-19 in the African American community. It is hypothesized that exposure to the SARS-CoV-2 virus and the development of COVID-19 will be associated with social and neighborhood factors, and that SARS-CoV-2 infection will adversely affect vascular function.
OBJECTIVES
Primary Objectives:
- Define the effect of social factors (e.g., socio-economic status; neighborhood characteristics) on exposure to SARS-CoV-2 and the development of COVID-19.
- Define the effect of SARS-CoV-2 infection and the development of COVID-19 on vascular function (e.g., pulse wave velocity).
- Examine how social factors influence the effect of SARS-CoV-2 and COVID-19 on vascular function.
Secondary Objectives:
- Examine the effects of SARS-CoV-2 infection and COVID-19 on epigenome (whole-blood), transcriptome, (whole-blood, plasma microvesicles, urine), peripheral blood mononuclear cell (PBMC) single-cell RNA-seq, biomarker profile (e.g., CRP; d-dimer), cardiac function (EKG) and leukocyte telomere length.
- Examine how social factors influence the effect of SARS-CoV-2 infection and COVID-19 on transcriptome and epigenome.
ENDPOINTS
Primary Endpoints:
SARS-CoV-2 infection
Vascular function (e.g., pulse wave velocity; vascular stiffness indices; reactive hyperemia)
Secondary Endpoints:
Transcriptome (whole-blood, plasma microvesicles, urine)
Epigenome (whole-blood)
PBMC single-cell RNA-seq
Leukocyte telomere length
Electrocardiogram (EKG)
Biomarker profile (CRP, D-Dimer, ACE-2, HS-Troponin)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GENEFORECAST | – | –African American men and women residing in the Washington DC area |
Who may qualify
- Ages
- 21 to 115 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 650 African American men and women residing in the metropolitan DC area who previously competed baseline activities in the GENE-FORECAST protocol. Participants will be at least 21 years of age.
Key inclusion criteria (5 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Self-identified African American men and women who previously enrolled in GENE-FORECAST, completed baseline activities and gave permission for recontact through the GENE-FORECAST protocol.
- Stated willingness to participate in study procedures.
- Ability of subject to understand and the willingness to give verbal informed consent for the CATI and the ability to understand and the willingness to sign a written informed consent document for the clinic visit.
- Individuals eligible for this protocol are previous GENE-FORECAST participants, all of whom are English speakers. Therefore, by default, this study includes only English speakers.
Key exclusion criteria (1 listed)
- Only individuals who completed the baseline protocol of GENE-FORECAST and gave permission for recontact through the GENE-FORECAST protocol will be invited to participate. Among this group, there are no exclusions for this study except those who are pregnant.
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
Define the effect of SARS-CoV-2 infection and the development of COVID-19 on vascular function (e.g., pulse wave velocity).
Time frame: 48 month
Vascular function (e.g., pulse wave velocity; vascular stiffness indices; reactive hyperemia)
Examine how social factors influence the effect of SARS-CoV-2 and COVID-19 on vascular function.
Time frame: 48 month
African Americans are disproportionately affected by SARS-CoV-2 infection and COVID-19. There are well-documented socioeconomic inequalities that contribute to this increased vulnerability. The disparate burden of disease demands a multidimensional approach informed by social determinants of health, geography (neighborhood), and personalized risk profiles. Among the social, environmental, clinical and genetic factors likely to be important for COVID-19 risks and outcomes, there is little understanding of the relative importance of these factors among African Americans and how they interact to affect morbidity and mortality.
Define the effect of social factors (e.g., socio-economic status; neighborhood characteristics) on exposure to SARS-CoV-2 and the development of COVID-19
Time frame: 48 month
Vascular function (e.g., pulse wave velocity; vascular stiffness indices; reactive hyperemia)
2 secondary outcomes
Examine how social factors influence the effect of SARS-CoV-2 infection and COVID-19 on transcriptome and epigenome.
Time frame: 48 month
Examine the effects of SARS-CoV-2 infection and COVID-19 on epigenome (whole-blood), transcriptome, (whole-blood, plasma microvesicles, urine), peripheral blood mononuclear cell (PBMC) single-cell RNA-seq, biomarker profile (e.g., CRP; d-dimer),...
Time frame: 48 month
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 24 Feb 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Laura M Koehly, Ph.D. principal investigator
National Human Genome Research Institute (NHGRI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease, run by National Human Genome Research Institute (NHGRI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. 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 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Define the effect of SARS-CoV-2 infection and the development of COVID-19 on vascular function (e.g., pulse wave velocity). (time frame: 48 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 24 Feb 2026.