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NCT04701515 Clinical Trial

Cardiovascular Manifestations of COVID-19

COVID-19 Clinical Trial

Official title:
Cardiovascular Manifestations of COVID-19

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04701515
Other study ID # 030.CVS.2020.D
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 21, 2023
Est. completion date May 21, 2024

Study information
Verified date July 2023
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Electronic medical record review of de-identified patients who tested positive for COVID-19 (using a PCR test) at Methodist Dallas Medical Center (MDMC) from June 2020 until the date of IRB approval. Data will be collected on de-identified patients that test positive for COVID-19 (using a PCR test) at MDMC from the date of IRB approval until December 2022. Disclaimer: Any cost associated with the procedures stated herein will be billed directly to you or to your insurance (as applicable)

Description:

Electronic medical record review of de-identified patients who tested positive for COVID-19 (using a PCR test) at Methodist Dallas Medical Center (MDMC) from June 2020 until the date of IRB approval. Data will be collected on de-identified patients that test positive for COVID-19 (using a PCR test) at MDMC from the date of IRB approval until December 2022. Variables include patient baseline characteristics, patient presentation, imaging and labs. Disclaimer: Any cost associated with the procedures stated herein will be billed directly to you or to your insurance (as applicable)

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 500
Est. completion date May 21, 2024
Est. primary completion date May 21, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Hospitalized patient - Adult over 18 years - Positive COVID-19 PCR Test Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Chart review
Chart review

Locations
Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Heart failure Presence or absence March 2020 - June 2021
Primary Tamponade Presence or absence March 2020 - June 2021
Primary Pericardial Effusion Presence or absence March 2020 - June 2021
Primary Myocarditis Presence or absence March 2020 - June 2021
Primary Pericarditis Presence or absence March 2020 - June 2021
Primary Arrythmias Presence or absence March 2020 - June 2021
Primary Troponin I Level March 2020 - June 2021
Primary N-terminal prohormone BNP Level March 2020 - June 2021
Secondary Stroke Presence or absence March 2020 - June 2021
Secondary Myocardial infarction Type March 2020 - June 2021
Secondary Shock Presence or absence March 2020 - June 2021
Secondary Deep venous thrombosis Presence or absence March 2020 - June 2021
Secondary Discharge disposition Location March 2020 - June 2021
Secondary Primary diagnosis Diagnosis upon discharge March 2020 - June 2021
Secondary Rate of ICU admission/transfer Rates March 2020 - June 2021
Secondary Total hospital length of stay Number of Days March 2020 - June 2021
Secondary ICU length of stay Number of Days March 2020 - June 2021
Secondary Percentage of patients in cohort that had EKG testing or Echocardiography Percentage March 2020 - June 2021
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