Recruiting

Observational Study

Sponsor:

Memorial Hermann Health System

Code:

NCT04335630

Conditions

Cardiovascular Diseases

COVID

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electrocardiogram, telemetry, echocardiogram, laboratory values

Study Details

Brief summary:

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen responsible for the novel coronavirus disease 2019 (COVID-19). The first reports of COVID-19 came from Wuhan, China in December of 2019. Since then, the disease has spread rapidly around the globe, accounting for thousands of deaths in multiple countries. On March 11th, 2020, the World Health Organization declared COVID-19 as a pandemic. Although COVID-19 manifests primarily as a respiratory illness, several cardiovascular implications have been reported related to its natural course and treatment. Its exact effect on the cardiovascular system though is currently unknown. Therefore, we propose a retrospective, observational, case-control study looking for cardiovascular manifestations of COVID-19, including laboratory evidence of myocardial injury, electrocardiographic changes, arrhythmias and echocardiographic abnormalities. Hospitalized patients admitted with fever, cough, sore throat, and/or dyspnea who were tested positive for SARS-CoV-2 will be included in our study and will be matched based on their age and gender with patients admitted with similar symptoms who tested negative for SARS-CoV-2. The electronic medical charts of the study subjects will be reviewed and relevant demographic, clinical, laboratory and imaging findings will be deidentified and recorded. Since our study will be a retrospective chart review study it carries minimal risk for the patients and the investigators. Cardiovascular disease associated with COVID-19 might be contributing to the high mortality rates and its recognition will allow for prevention, early diagnosis and appropriate treatment. This will be the first, large, case-control study assessing cardiovascular involvement of COVID-19 in a well-defined cohort of patients.

Conditions

Cardiovascular Diseases

COVID

Study ID

NCT04335630

Start date

Mar 30, 2020

Status verified date

Apr, 2020

Completion date

Mar, 2022

Anticipated

Primary completion date

Mar, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients admitted to the hospital with symptoms of fever, sore throat, cough, nasal congestion and/or dyspnea who were tested positive for SARS-CoV-2 by PCR

Exclusion Criteria:

  • Patients of high clinical suspicion for COVID-19 with only one negative PRC test for SARS-CoV-2
  • Patients with COVID-19 who do not require hospitalization

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Cases

Patients admitted to the hospital with symptoms of fever, sore throat, cough, nasal congestion and/or dyspnea who were tested positive for SARS-CoV-2 by PCR.

Controls

Age- and gender-matched subjects admitted to the hospital with similar symptoms but negative PCR testing for SARS-CoV-2 (one negative PCR test for patients of low clinical suspicion and two negative tests, 24 hours apart from each other, for patients of high clinical suspicion).

Interventions

Electrocardiogram, telemetry, echocardiogram, laboratory values

Serial electrocardiograms, telemetry monitoring, echocardiographic assessment and serial laboratory testing will be used to identify differences among the two study groups.

Primary outcome measure

  • Prevalence of cardiomyopathy, myocardial infarction, heart failure, clinically significant arrhythmias, cardiogenic shock or cardiac arrest. [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Heinrich Taegtmeyer, MD, DPhil

Heinrich.Taegtmeyer@uth.tmc.edu

Locations

Memorial Hermann Hospital-Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

Memorial Hermann Health System

Last update posted

Apr 7, 2020

Last verified

Apr, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Hermann Health System on 2020-04-07.