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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000577-HG

Sponsoring Institute

National Human Genome Research Institute (NHGRI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 21 Years
Max Age: 115 Years

Referral Letter Required

Yes

Population Exclusion(s)

White;
Non-English Speaking;
Native Hawaiian/Pacific Islander;
Children;
Asian;
American Indian or Alaskan Native

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Heart Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Human Genome Research Institute

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.

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Eligibility

INCLUSION CRITERIA

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.

EXCLUSION CRITERIA

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Laura M. Koehly, Ph.D.
National Human Genome Research Institute (NHGRI)
National Institutes of Health
Building 31
Room B1B54
31 Center Drive
Bethesda, Maryland 20892
(301) 451-3999
koehlyl@mail.nih.gov

Nicole Plass-Hermitt, R.N.
National Human Genome Research Institute (NHGRI)
National Institutes of Health
Building 10
Room 7N317
10 Center Drive
Bethesda, Maryland 20892
(301) 451-3911
plassn@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05484882

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