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Cardiovascular Manifestations of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04335630
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Efstratios Koutroumpakis, Memorial Hermann Health System

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.

Condition or disease Intervention/treatment
Cardiovascular Diseases COVID Diagnostic Test: Electrocardiogram, telemetry, echocardiogram, laboratory values

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Cardiovascular Manifestations of Hospitalized Patients With Coronavirus Disease 2019
Actual Study Start Date : March 30, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Group/Cohort Intervention/treatment
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.
Diagnostic Test: 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.

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

Secondary Outcome Measures :
  1. Prevalence of pericarditis, pericardial effusion, valvular disease. [ Time Frame: One year ]
  2. Identification of characteristic electrocardiographic patterns related to COVID-19 [ Time Frame: One year ]
  3. Role of active cardiovascular disease in clinical outcomes of patients with COVID-19 including length of ICU stay, length of hospitalization and mortality. [ Time Frame: One year ]
  4. Role of pre-existing cardiovascular comorbidities in clinical course of COVID-19 [ Time Frame: One year ]
  5. Role of treatment with ACE inhibitors or ARBs in the clinical course of COVID-19 [ Time Frame: One year ]
  6. Role of insurance type on clinical outcomes of patients with COVID-19 [ Time Frame: One year ]
  7. Effect of age, gender and race on clinical course of COVID-19 and prevalence of cardiovascular complications [ Time Frame: One year ]
  8. Role of active smoking on clinical course of COVID-19 and prevalence of cardiovascular complications [ Time Frame: One year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects admitted to the COVID unit and medical intensive care unit of Memorial Hermann Hospital/Texas Medical Center from March 30th, 2020 to March 30th, 2021 will be identified by location search of the electronic medical records. Subjects who were tested positive for SARS-CoV-2 by PCR will be age- and gender-matched with subjects admitted to the COVID unit or medical intensive care unit with similar symptoms but negative PCR tests 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). Demographic, clinical, laboratory and imaging findings will be collected by retrospective electronic chart review.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335630


Contacts
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Contact: Efstratios Koutroumpakis, MD 4123203161 Efstratios.Koutroumpakis@uth.tmc.edu
Contact: Heinrich Taegtmeyer, MD, DPhil Heinrich.Taegtmeyer@uth.tmc.edu

Locations
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United States, Texas
Memorial Hermann Hospital-Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Efstratios Koutroumpakis, MD    412-320-3161    Efstratios.Koutroumpakis@uth.tmc.edu   
Sponsors and Collaborators
Memorial Hermann Health System
Publications:
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Responsible Party: Efstratios Koutroumpakis, MD, Memorial Hermann Health System
ClinicalTrials.gov Identifier: NCT04335630    
Other Study ID Numbers: HSC-MS-20-0286
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases