Clinical trial NCT04701515: Cardiovascular Manifestations of COVID-19
Official title: Cardiovascular Manifestations of COVID-19
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: COVID-19
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that test positive for COVID-19 (using a PCR test) at MDMC

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)

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Heart failure
timeFrame: March 2020 - June 2021
measure: Tamponade
timeFrame: March 2020 - June 2021
measure: Pericardial Effusion
timeFrame: March 2020 - June 2021
measure: Myocarditis
timeFrame: March 2020 - June 2021
measure: Pericarditis
timeFrame: March 2020 - June 2021
measure: Arrythmias
timeFrame: March 2020 - June 2021
measure: Troponin I
timeFrame: March 2020 - June 2021
measure: N-terminal prohormone BNP
timeFrame: March 2020 - June 2021
Secondary outcomes:
measure: Stroke
timeFrame: March 2020 - June 2021
measure: Myocardial infarction
timeFrame: March 2020 - June 2021
measure: Shock
timeFrame: March 2020 - June 2021
measure: Deep venous thrombosis
timeFrame: March 2020 - June 2021
measure: Discharge disposition
timeFrame: March 2020 - June 2021
measure: Primary diagnosis
timeFrame: March 2020 - June 2021
measure: Rate of ICU admission/transfer
timeFrame: March 2020 - June 2021
measure: Total hospital length of stay
timeFrame: March 2020 - June 2021
measure: ICU length of stay
timeFrame: March 2020 - June 2021
measure: Percentage of patients in cohort that had EKG testing or Echocardiography
timeFrame: March 2020 - June 2021
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Manavjot Sidhu, MD
role: PRINCIPAL_INVESTIGATOR
References: