Cardiovascular Manifestations of COVID-19

NCT04335630 | Unknown

• 1 other identifier: HSC-MS-20-0286
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of cardiomyopathy, myocardial infarction, heart failure, clinically significant arrhythmias, cardiogenic shock or cardiac arrest.

  One year

Secondary Outcomes (8)

• Prevalence of pericarditis, pericardial effusion, valvular disease.

  One year

• Identification of characteristic electrocardiographic patterns related to COVID-19

  One year

• Role of active cardiovascular disease in clinical outcomes of patients with COVID-19 including length of ICU stay, length of hospitalization and mortality.

  One year

• Role of pre-existing cardiovascular comorbidities in clinical course of COVID-19

  One year

• Role of treatment with ACE inhibitors or ARBs in the clinical course of COVID-19

  One year

Study Arms (2)

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

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

Interventions

Electrocardiogram, telemetry, echocardiogram, laboratory values DIAGNOSTIC_TEST

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

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Hermann Health System: lead

Study Sites (1)

Memorial Hermann Hospital-Texas Medical Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (3)

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 BACKGROUND

• Xiong TY, Redwood S, Prendergast B, Chen M. Coronaviruses and the cardiovascular system: acute and long-term implications. Eur Heart J. 2020 May 14;41(19):1798-1800. doi: 10.1093/eurheartj/ehaa231. No abstract available.

  PMID: 32186331 BACKGROUND

• Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.

  PMID: 32139904 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Electrocardiography; Telemetry; Echocardiography

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Physiologic; Investigative Techniques; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography

Central Study Contacts

Efstratios Koutroumpakis, MD

CONTACT

4123203161; Efstratios.Koutroumpakis@uth.tmc.edu

Heinrich Taegtmeyer, MD, DPhil

CONTACT

Heinrich.Taegtmeyer@uth.tmc.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: March 30, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2022
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

US (1)