Cardiovascular Manifestations of COVID-19

• Conditions: COVID-19
• Interventions: Other: Chart review

• Registration Number: NCT04701515
• Lead Sponsor: Methodist Health System

Brief 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)

Detailed 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)

Study Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-08
• Study Start: 2023-03-21
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12
• Primary Completion: 2024-05-21
• Study Completion: 2024-05-21

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Hospitalized patient
• Adult over 18 years
• Positive COVID-19 PCR Test

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective Cohort	Chart review	Review electronic medical records of de-identified patients that tested positive for COVID-19 (using a PCR test) at Methodist Dallas Medical Center (MDMC) from June 2020 until December 2022

Primary Outcome Measures

Name	Time	Method
Pericarditis	March 2020 - June 2021	Presence or absence
Pericardial Effusion	March 2020 - June 2021	Presence or absence
Tamponade	March 2020 - June 2021	Presence or absence
Myocarditis	March 2020 - June 2021	Presence or absence
Heart failure	March 2020 - June 2021	Presence or absence
Arrythmias	March 2020 - June 2021	Presence or absence
Troponin I	March 2020 - June 2021	Level
N-terminal prohormone BNP	March 2020 - June 2021	Level

Secondary Outcome Measures

Name	Time	Method
Rate of ICU admission/transfer	March 2020 - June 2021	Rates
Myocardial infarction	March 2020 - June 2021	Type
ICU length of stay	March 2020 - June 2021	Number of Days
Deep venous thrombosis	March 2020 - June 2021	Presence or absence
Primary diagnosis	March 2020 - June 2021	Diagnosis upon discharge
Percentage of patients in cohort that had EKG testing or Echocardiography	March 2020 - June 2021	Percentage
Stroke	March 2020 - June 2021	Presence or absence
Discharge disposition	March 2020 - June 2021	Location
Total hospital length of stay	March 2020 - June 2021	Number of Days
Shock	March 2020 - June 2021	Presence or absence

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States