Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African-Americans Study (GENE-FORECAST): Prospective COVID-19 Natural History Study

NCT05484882 | Completed

• 2 other identifiers: 10000577000577-HG
• Study Type: observational
• Target: 431
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Heart Disease

Keywords

African-American; Cardiovascular Disease; COVID-19; Natural History

Outcome Measures

Primary Outcomes (3)

• 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)

  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.

  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)

  48 month

Secondary Outcomes (2)

• Examine how social factors influence the effect of SARS-CoV-2 infection and COVID-19 on transcriptome and epigenome.

  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),...

  48 month

Study Arms (1)

GENEFORECAST

African American men and women residing in the Washington DC area

Eligibility Criteria

• Age: 21 Years - 115 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead

Study Sites (2)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Westat, Inc.

Rockville, Maryland, 20850, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Heart Diseases; Cardiovascular Diseases; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Laura M Koehly, Ph.D.

  National Human Genome Research Institute (NHGRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2022
• First Posted: August 2, 2022
• Study Start: February 18, 2023
• Primary Completion: June 26, 2023
• Study Completion: June 26, 2023
• Last Updated: February 24, 2026

Record last verified: 2026-02-19

Locations

US (2)