Clinical Trials Logo

Clinical Trial Summary

At the end of December of 2019, a series of patients in Wuhan, China were struck with a mysterious respiratory infection. These isolated events have rapidly grown into a deadly, global pandemic. This pandemic is caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which results in the Coronavirus Disease 2019 (COVID-19). For individuals infected with COVID-19, approximately 30% of the hospitalized cases are associated with cardiovascular complications. Data are emerging that individuals with pre-exiting conditions (like hypertension, diabetes, cancer, or medical issues related to the immune system) are most susceptible to complications related to COVID-19. Furthermore, individuals of certain racial and ethnic backgrounds (e.g. African American and Hispanic) are at a higher risk of death from COVID-19. Despite these emerging observations, it remains unclear who will develop the cardiovascular complications (acute myocardial injury with evidence of a myocarditis-like picture and cardiogenic shock) and what the long term sequelae of this disease will be for survivors of this infection after hospitalization. Thus, the goals of this project are to better understand the epidemiology of cardiac injury in acutely ill COVID-19 patients through deep cardiac phenotyping and identify the molecular profile of individuals most susceptible to cardiac injury from COVID-19.


Clinical Trial Description

This will be a cross-sectional cohort study of participants who will undergo a detailed cardiovascular imaging evaluation and blood draw once they have recuperated from a prior index-hospitalization at Clements University Hospital or Parkland Memorial Hospital in Dallas, Texas, USA for COVID-19 and are no longer contagious (~4-6 weeks post hospitalization). Due to the uncertainty with which the extent of cardiac injury represents phenotypic cardiac manifestations in COVID-19, the investigators plan to enroll individuals according to their highest, in-hospital, (high sensitivity - cardiac troponin T) hs-cTnT. The following proposed stratification scheme will afford testing a spectrum hs-cTnT levels. Table: Enrollment strata by hs-cTnT (N=70) hs-cTnT [ng/L] < 50 50-100 101-500 > 500 Enrollment N=20 N=20 N=20 N=10 The investigators propose the following exploratory protocol for deep phenotyping to characterize surviving patients with COVID-19 and elevated hs-cTnT during hospitalization. All participants will undergo a protocolized multiparametric cardiac magnetic resonance imaging (CMR) assessment with an electrocardiography-gated breath hold protocol under the oversight of study personnel and read by a reader blinded to hs-cTnT data from the COVID-19 index hospitalization. Conventional 1H CMR evaluations will include T2 maps, native and post-contrast T1 maps, as well as extracellular volume index calculation and late gadolinium for inflammatory injury. Standardized adenosine hyperemic stress perfusion CMR will be performed for quantitative myocardial blood flow analysis. In addition to conventional 1H CMR a subset of 5 patients from the highest and lowest troponin groups, age- and BMI-matched, will undergo hyperpolarized 13C metabolic CMR with infusion of [1-13C] pyruvate under fasting conditions to assess inflammation and post carbohydrate load to assess a decrease in myocardial mitochondrial oxidative metabolism. Biospecimens will be collected by study personnel at the time of CMR or preliminary study site visit. A fasting venous blood sample (50 cc) will be collected, maintained on ice and transported to the Mammen Laboratory, which is located on the campus of UT Southwestern. Both serum and plasma will be isolated and aliquoted for storage and immediately frozen and stored until use and will not undergo any freeze-thaw cycles. RNA and protein will be extracted from the samples for biomarker and autoantibody (AAb) assays. The presence of cardiac-specific AAbs has been shown to be involved in both the manifestation and development of cardiac disease manifestation and predicting disease development. Utilizing a customized ELISA-based detection assay, ~20 circulating cardiac-specific AAbs that have been reported to be associated with heart failure will be assessed and quantified during the early (1-2 months post-hospitalization) phases of the patient post COVID-19 hospitalization course. Leukocytes will be isolated from the biospecimens samples and genomic DNA will be extracted from the cells to perform Next Generation Whole Exome Sequencing (WES). These studies will be undertaken in the Next-Generation Sequencing Core on campus. Capitalizing on a well-established research collaboration between the Mammen Laboratory and the McDermott bioinformatics group, the WES data will be analyzed for genetic mutations associated with cardiomyopathy as well as autoimmunity. If funds are available, both the imaging and molecular assessments will be duplicated in individuals with paired data after an additional 10-12 months from hospitalization. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04435457
Study type Observational [Patient Registry]
Source University of Texas Southwestern Medical Center
Contact
Status Terminated
Phase
Start date September 1, 2020
Completion date May 20, 2023

See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure