- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04701515
Cardiovascular Manifestations of COVID-19
May 15, 2026 updated by: Methodist Health System
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)
Study Overview
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 Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Dallas, Texas, United States, 75203
- Methodist Dallas Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients that test positive for COVID-19 (using a PCR test) at MDMC
Description
Inclusion Criteria:
- Hospitalized patient
- Adult over 18 years
- Positive COVID-19 PCR Test
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Retrospective Cohort
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
|
Chart review
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart failure
Time Frame: March 2020 - June 2021
|
Presence or absence
|
March 2020 - June 2021
|
|
Tamponade
Time Frame: March 2020 - June 2021
|
Presence or absence
|
March 2020 - June 2021
|
|
Pericardial Effusion
Time Frame: March 2020 - June 2021
|
Presence or absence
|
March 2020 - June 2021
|
|
Myocarditis
Time Frame: March 2020 - June 2021
|
Presence or absence
|
March 2020 - June 2021
|
|
Pericarditis
Time Frame: March 2020 - June 2021
|
Presence or absence
|
March 2020 - June 2021
|
|
Arrythmias
Time Frame: March 2020 - June 2021
|
Presence or absence
|
March 2020 - June 2021
|
|
Troponin I
Time Frame: March 2020 - June 2021
|
Level
|
March 2020 - June 2021
|
|
N-terminal prohormone BNP
Time Frame: March 2020 - June 2021
|
Level
|
March 2020 - June 2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stroke
Time Frame: March 2020 - June 2021
|
Presence or absence
|
March 2020 - June 2021
|
|
Myocardial infarction
Time Frame: March 2020 - June 2021
|
Type
|
March 2020 - June 2021
|
|
Shock
Time Frame: March 2020 - June 2021
|
Presence or absence
|
March 2020 - June 2021
|
|
Deep venous thrombosis
Time Frame: March 2020 - June 2021
|
Presence or absence
|
March 2020 - June 2021
|
|
Discharge disposition
Time Frame: March 2020 - June 2021
|
Location
|
March 2020 - June 2021
|
|
Primary diagnosis
Time Frame: March 2020 - June 2021
|
Diagnosis upon discharge
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March 2020 - June 2021
|
|
Rate of ICU admission/transfer
Time Frame: March 2020 - June 2021
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Rates
|
March 2020 - June 2021
|
|
Total hospital length of stay
Time Frame: March 2020 - June 2021
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Number of Days
|
March 2020 - June 2021
|
|
ICU length of stay
Time Frame: March 2020 - June 2021
|
Number of Days
|
March 2020 - June 2021
|
|
Percentage of patients in cohort that had EKG testing or Echocardiography
Time Frame: March 2020 - June 2021
|
Percentage
|
March 2020 - June 2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Manavjot Sidhu, MD, Methodist Health System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2023
Primary Completion (Actual)
July 3, 2023
Study Completion (Actual)
July 3, 2023
Study Registration Dates
First Submitted
September 22, 2020
First Submitted That Met QC Criteria
January 6, 2021
First Posted (Actual)
January 8, 2021
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 15, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 030.CVS.2020.D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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