Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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: 1. 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. 2. Define the effect of SARS-CoV-2 infection and the development of COVID-19 on vascular function (e.g., pulse wave velocity). 3. Examine how social factors influence the effect of SARS-CoV-2 and COVID-19 on vascular function. Secondary Objectives: 1. 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. 2. 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


Related Conditions & MeSH terms


NCT number NCT05484882
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact Nicole Plass-Hermitt, R.N.
Phone (301) 451-3911
Email [email protected]
Status Recruiting
Phase
Start date August 10, 2022
Completion date June 3, 2030

See also
  Status Clinical Trial Phase
Completed NCT03481322 - Low Sodium Cooking Study N/A
Completed NCT00001638 - Magnetic Resonance Imaging of the Blood Vessels of the Heart
Completed NCT02376244 - The Health Impact of High Intensity Exercise Training With Intervals During Cardiac Rehabilitation N/A
Completed NCT02523144 - Dexmedetomidine in Children Having Transthoracic Echocardiography Phase 4
Completed NCT02277379 - Prediction of Bleeding and Transfusion Outcomes and Assessment of Perioperative Platelet Reactivity in Cardiac Surgery N/A
Completed NCT02045641 - Pleural and Pericardial Effusion Following Open Heart Surgery N/A
Completed NCT01871090 - Remote Device Interrogation In The Emergency Department N/A
Active, not recruiting NCT01400490 - Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study N/A
Completed NCT01192360 - Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease Phase 3
Terminated NCT00935766 - Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries Phase 3
Completed NCT00745446 - The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation N/A
Completed NCT00140816 - Dairy Products and Metabolic Effects (Norwegian Part) N/A
Completed NCT00013949 - Cardiovascular Vulnerability to Particulate Exposure N/A
Completed NCT01952171 - The Genetic Basis of Congenital Heart Disease in Africa
Recruiting NCT02933892 - Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization Phase 4
Withdrawn NCT02838355 - Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients N/A
Completed NCT02923518 - Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes)
Terminated NCT02282163 - Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography Phase 3
Recruiting NCT02260466 - Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement. N/A
Completed NCT03820752 - Vaccination Coverage and Level of Protection in Patients at Risk