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

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ClinicalTrials.gov Identifier: NCT05085262
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Dinesh Thavendiranathan, University Health Network, Toronto

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.


Condition or disease Intervention/treatment
COVID-19 Respiratory Infection Diagnostic Test: Bloodwork, Echocardiogram, PET/MRI Diagnostic Test: Bloodwork, Echocardiogram, MRI

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Disease and Outcomes Among Patients With SARS-CoV-2 (COVID-19) Infection During Hospital Admission and Post Discharge
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

Group/Cohort Intervention/treatment
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
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.

Moderate Disease
Those admitted but never requiring transfer to ICU or similar advanced care setting
Diagnostic Test: Bloodwork, Echocardiogram, PET/MRI
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.

Severe Disease
Those requiring admission to ICU or other advanced care settings (i.e. other Level 2 beds)
Diagnostic Test: Bloodwork, Echocardiogram, PET/MRI
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.

Control Group
Those with a negative COVID-19 and no history of COVID-19
Diagnostic Test: Bloodwork, Echocardiogram, MRI
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.




Primary Outcome Measures :
  1. Prevalence of abnormalities on cardiac MRI [ Time Frame: 3 months ]
    The prevalence of myocardial inflammation and damage on cardiac MRI will be compared between patients with COVID-19 and controls.


Secondary Outcome Measures :
  1. Prevalence of abnormalities on transthoracic echocardiography [ Time Frame: 3 months ]
    The prevalence of cardiac abnormalities on echocardiography will be compared between patients with COVID-19 and controls.

  2. Number of participants with abnormal blood biomarkers [ Time Frame: 3 months ]
    Circulating blood markers of acute cardiac damage, endothelial and coagulation pathway activation, and microRNA biomarker profiles will be compared between patients admitted to the hospital versus those discharged from the emergency department

  3. Major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: 12 months ]
    MACCE is a composite of: Myocardial infarction; Unplanned coronary revascularization (PCI, CABG, thrombolysis) ; Heart failure hospitalization; Stroke (ischemic only); Arrhythmia requiring hospitalization; Cardiovascular death

  4. Prevalence of myocardial inflammation on PET/MRI [ Time Frame: 1 months ]
    The prevalence of myocardial inflammation on PET/MRI will be evaluated in a subgroup of 50 patients recovered from COVID-19.


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnancy.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085262


Contacts
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Contact: Tiffanie Kei 416-340-4800 ext 6594 tiffanie.kei@uhn.ca

Locations
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Canada, Ontario
Toronto General Hospital, UHN Recruiting
Toronto, Ontario, Canada, M5G2N2
Contact: Tiffanie Kei    416-340-4800 ext 6594    tiffanie.kei@uhn.ca   
Principal Investigator: Dinesh Thavendiranathan         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Dinesh Thavendiranathan University Health Network, Toronto
Principal Investigator: Kate Hanneman University Health Network, Toronto
Principal Investigator: Kathryn Howe University Health Network, Toronto
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Responsible Party: Dinesh Thavendiranathan, Cardiologist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT05085262    
Other Study ID Numbers: COVID-19 Study 20-5453
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Respiratory Tract Infections
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases