Cardiovascular Disease and Outcomes Among Patients With SARS-CoV-2 Infection (COVID-19)

NCT05085262 | Unknown

• 1 other identifier: COVID-19 Study 20-5453
• Study Type: observational
• Target: 251
• Locations: 1 country
• Sites: 1

Brief Summary

The coronavirus disease of 2019 (COVID-19) has affected over 2.4 million individuals worldwide and has resulted in \>171,000 deaths. Cardiovascular disease (CVD) is an important contributor to death in these patients. Those who develop cardiac injury during infection have a 4-fold increased risk of death. Furthermore, pre-existing CVD or cardiovascular risk factors (e.g. diabetes, hypertension) are associated with worse outcomes. Given the recent emergence of this disease, there is limited understanding of: (i) the risk factors for cardiovascular events, (ii) blood biomarkers for early recognition, and drug targeting, of patients at risk of adverse outcomes, and (iii) the short term subclinical and clinical cardiovascular manifestations in those who survive to discharge.

Conditions

COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• Prevalence of abnormalities on cardiac MRI

  The prevalence of myocardial inflammation and damage on cardiac MRI will be compared between patients with COVID-19 and controls.

  3 months

Secondary Outcomes (4)

• Prevalence of abnormalities on transthoracic echocardiography

  3 months

• Number of participants with abnormal blood biomarkers

  3 months

• Major adverse cardiac and cerebrovascular events (MACCE)

  12 months

• Prevalence of myocardial inflammation on PET/MRI

  1 months

Study Arms (4)

Mild Disease

Those assessed as an outpatient or discharged from the emergency department and never admitted elsewhere based on patient history

Diagnostic Test: Bloodwork, Echocardiogram, PET/MRI

Moderate Disease

Those admitted but never requiring transfer to ICU or similar advanced care setting

Diagnostic Test: Bloodwork, Echocardiogram, PET/MRI

Severe Disease

Those requiring admission to ICU or other advanced care settings (i.e. other Level 2 beds)

Diagnostic Test: Bloodwork, Echocardiogram, PET/MRI

Control Group

Those with a negative COVID-19 and no history of COVID-19

Diagnostic Test: Bloodwork, Echocardiogram, MRI

Interventions

Bloodwork, Echocardiogram, PET/MRI DIAGNOSTIC_TEST

The study will use blood samples from COVID biobank at University Health Network. Samples will be collected at time of admission to ER in patients discharged after assessment and at three time points during admission in patients who are admitted for measurement of blood biomarkers. Echocardiography studies will be assessed for structural and functional abnormalities. All included patients will have prospective short-term follow-up (3-6 months) for assessment of clinical events and subclinical cardiovascular disease. 50 patients who had clinical cardiac MRI at our center within 5 years prior to COVID-19 (January 2015-January 2020) and have since tested positive for COVID-19 will be recruited for research cardiac MRI to compare changes between baseline (pre-COVID) and follow-up (post-COVID imaging). A subgroup of 50 patients will undergo cardiac PET/MRI at 1-3 months post COVID-19 diagnosis to evaluate for myocardial inflammation and other imaging markers of cardiac injury.

Mild Disease; Moderate Disease; Severe Disease

Bloodwork, Echocardiogram, MRI DIAGNOSTIC_TEST

The study will involve use of blood samples from the COVID biobank at UHN (University Health Network) for measurement of blood biomarkers. Echocardiography Studies will be systematically assessed for structural and functional abnormalities. All included patients assessment of clinical events and subclinical cardiovascular disease.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll a total of 300 participants seen at UHN and SMH - 250 patients who have confirmed COVID-19 and 50 COVID-19- patients as a control group.

You may qualify if:

• COVID-19+ confirmed by RT-PCR (Reverse Transcriptase - Polymerase Chain Reaction).
• Age ≥ 18 years.

You may not qualify if:

• \. Pregnancy.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital, UHN

Toronto, Ontario, M5G2N2, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples will be collected at time of admission to ER in those who are discharged after assessment and at three time points during admission in patients who are admitted for measurement of blood biomarkers

MeSH Terms

Interventions

Echocardiography; Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Tomography

Study Officials

• Dinesh Thavendiranathan

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Kate Hanneman

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Kathryn Howe

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 20, 2021
• Study Start: July 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: September 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

CA (1)