Cardiovascular Implications of COVID-19

NCT04435457 | Terminated

• 1 other identifier: STU-2020-0359
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-CoV 2; SARS Pneumonia; COVID-19; SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere; Cardiac Complication

Keywords

SARS-CoV 2; Troponin; Cardiac injury; COVID-19

Outcome Measures

Primary Outcomes (1)

• Prevalence of Myocarditis

  Patterns of late gadolinium enhancement and T1 and T2 mapping consistent with myocarditis on a post-hospitalization cardiac magnetic resonance imaging examination

  Up to 4 weeks

Secondary Outcomes (2)

• Prevalence of cardiac abnormalities by cardiac magnetic resonance imaging

  Up to 4 weeks

• Prevalence of molecular and genetic immune system abnormalities

  Up to 4 weeks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consenting adults with a prior hospitalization for COVID-19 at either Parkland Memorial Hospital or Clements University Hospital in Dallas, Texas, USA who have recovered and are no-longer at-risk of COVID-19 disease transmission according the United States Centers for Disease Control guidelines will be considered for inclusion. All patients admitted to either hospital with suspected or confirmed COVID-19 receive an in-hospital standard-of-care metabolic, cardiac, and inflammatory biomarker protocolized assessment that includes daily basic metabolic panels, complete blood counts with differential, hs-cTnT, and C-reactive protein (CRP) coupled with every third day amino terminal pro-B-type natriuretic peptide (NT-proBNP), D-dimer, and ferritin. These labs are obtained from the day of admission to discharge. \]

You may qualify if:

• Men and non-pregnant women 18-80 years old who were previously hospitalized with confirmed COVID-19
• Were alive at the time of discharge from COVID-19 hospitalization
• Had measured hs-cTnT levels during hospitalization

You may not qualify if:

• Prior cardiovascular disease (before COVID-19 infection), defined as self-reported history or electronic medical record diagnosis of cardiac arrest, myocardial infarction, coronary revascularization, heart failure, or stroke prior to COVID-19 hospitalization
• Urgent-coronary revascularization or type I myocardial infarction within the preceding 30 days
• Cardiac transplantation
• Body weight \>250 lbs
• Moderate to severe chronic renal dysfunction defined by an eGFR ≤30 mL/min/1.73 m2
• Inability to safely undergo a CMR
• Unwilling or unable to provide informed consent

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Justin L Grodin, MD, MPH

  UT Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 17, 2020
• Study Start: September 1, 2020
• Primary Completion: May 20, 2023
• Study Completion: May 20, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

US (1)