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Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African-Americans Study (GENE-FORECAST): Prospective COVID-19 Natural History Study - Trial NCT05484882

Access comprehensive clinical trial information for NCT05484882 through Pure Global AI's free database. This phase not specified trial is sponsored by National Human Genome Research Institute (NHGRI) and is currently Recruiting. The study focuses on Heart Disease. Target enrollment is 650 participants.

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NCT05484882
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Trial Details
ClinicalTrials.gov โ€ข NCT05484882
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Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African-Americans Study (GENE-FORECAST): Prospective COVID-19 Natural History Study
Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African Americans Study (GENEFORECAST): Prospective COVID-19 Natural History Study

Study Focus

Heart Disease

Observational

Sponsor & Location

National Human Genome Research Institute (NHGRI)

National Institutes of Health Clinical Center (CC)

Bethesda, United States of America

Timeline & Enrollment

N/A

Nov 14, 2022

Jun 03, 2030

650 participants

Primary Outcome

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.,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

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.

ICD-10 Classifications

Heart disease, unspecified
Complications and ill-defined descriptions of heart disease
Other ill-defined heart diseases
Other forms of heart disease
Hypertensive heart disease

Data Source

ClinicalTrials.gov

NCT05484882

Non-Device Trial