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
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.
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.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT05484882