COVID-19 Respiratory InfectionNCT05085262
Cardiovascular Disease and Outcomes Among Patients With SARS-CoV-2 Infection (COVID-19)
An observational study of COVID-19 Respiratory Infection, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Respiratory Infection
- What is being tested?
- Bloodwork, Echocardiogram, PET/MRI and Bloodwork, Echocardiogram, MRI
- How many people
- 251 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2020to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- COVID-19+ confirmed by RT-PCR (Reverse Transcriptase - Polymerase Chain Reaction).
- Age ≥ 18 years.
Who cannot join
- 1. Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Disease and Outcomes Among Patients With SARS-CoV-2 (COVID-19) Infection During Hospital Admission and Post Discharge
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.
Read the detailed description
COVID-19 and CVD: On March 11, 2020 the coronavirus disease of 2019 (COVID-19), which is caused by infection with SARS-CoV-2 virus, was declared a pandemic by the World Health Organization. Incredibly, >2,400,000 cases and >171,000 deaths have been reported globally as of April 21, 2020. While the overall case fatality is ~5%, the mortality rate is dramatically higher in selected populations, particularly in those with preexistent and/or new-onset cardiovascular disease (CVD)2. Early reports suggest that up to 20-28% of hospitalized patients with confirmed COVID-19 (COVID-19+) have evidence of cardiovascular injury, defined as troponin elevation with or without other cardiovascular manifestations such as ischemia, ventricular arrhythmias, and left ventricular dysfunction (LVD). While SARS-CoV-1 virus can directly infect the heart4, it is still not clear whether this is the case for SARS-CoV-2. Nevertheless, cardiovascular injury may result from indirect damage secondary to hypoxemia, sepsis, cytokine release, endothelial injury or from direct myocardial involvement. Regardless of the mechanism, early studies demonstrate that cardiovascular injury is associated with a 4-fold increased risk of death, independent of age, cardiovascular risk factors, preexistent CVD, non-CVD comorbidities, and ARDS (Acute Respiratory Distress Syndrome).The presence of CVD and cardiac injury appear to have a synergistic effect on adverse prognosis.5 However, the long-term consequences of this acute cardiovascular injury are not known, but are likely to be significant. Therefore, understanding early markers of cardiovascular injury, their association with adverse events (cardiovascular and non-cardiovascular) and post-discharge cardiovascular consequences of COVID-19 will allow better care of these patients.
Rationale for the study This study will address the above-mentioned knowledge gaps by focusing on patients with a broad spectrum of disease severity. It will include patients admitted to the hospital (sicker group) and those discharged from the emergency department (healthier group). It will focus on endothelial and cardiac blood biomarkers to facilitate early recognition of patients at risk for adverse events and characterize in-hospital and post-discharge cardiovascular sequelae of COVID-19. Ultimately, the intention is to identify patients at risk, reduce in-hospital and post-discharge adverse events, and determine the need for longer-term CVD prevention strategies and follow-up in survivors.
Endothelial cells (ECs) line every blood vessel within the human body and play a key role in CVD. During early COVID-19 infection ECs in the alveolar unit in the lung are likely injured due to the antiviral response of the lung cells. Furthermore, ECs also have receptors on their surface that can allow the virus to enter into the circulation and travel to other organs, including the heart. Therefore, damage to the endothelium, both directly or due to the body's antiviral inflammatory response, can contribute to cardiac injury and poor overall outcomes.
Cardiac injury can be identified by the release of cardiac markers in the blood such as troponin I and B-type natriuretic peptides, which can often be seen before overt heart dysfunction occurs. Therefore, we propose that measurement of both endothelial activation and cardiac-specific markers from patient's blood early after infection (i.e. at presentation) and during hospital admission, can serve as an indicator of early cardiovascular injury. Correlating these findings with abnormalities in cardiac functional tests as well as cardiovascular and non-cardiovascular adverse outcomes during admission and follow-up, will help us use these biomarkers to institute targeted prevention strategies.
Given that the majority of patients (>95%) who are infected with the virus survive, and cardiac injury during the infection is common, it is likely that there is significant unrecognized cardiac injury in survivors. This is often undetected during admission or in those discharged from the emergency department (ER) due to inability to perform complete cardiovascular assessment. To understand subclinical cardiovascular injury, all patients will be brought back 3-6 months for complete cardiac assessment using echocardiography, cardiac MRI, and bloodwork. This knowledge will enable strategies to prevent subsequent overt CVD events and to determine the need for further investigations and long-term follow-up in COVID-19 survivors.
- Conditions
- COVID-19 Respiratory Infection
- Being tested
- Bloodwork, Echocardiogram, PET/MRI, Bloodwork, Echocardiogram, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bloodwork, Echocardiogram, PET/MRIDiagnostic 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.
Bloodwork, Echocardiogram, MRIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Mild Disease | Those assessed as an outpatient or discharged from the emergency department and never admitted elsewhere based on patient history Receives: Diagnostic Test: Bloodwork, Echocardiogram, PET/MRI | |
| Moderate Disease | Those admitted but never requiring transfer to ICU or similar advanced care setting Receives: Diagnostic Test: Bloodwork, Echocardiogram, PET/MRI | |
| Severe Disease | Those requiring admission to ICU or other advanced care settings (i.e. other Level 2 beds) Receives: Diagnostic Test: Bloodwork, Echocardiogram, PET/MRI | |
| Control Group | Those with a negative COVID-19 and no history of COVID-19 Receives: Diagnostic Test: Bloodwork, Echocardiogram, MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
Prevalence of abnormalities on transthoracic echocardiography
The prevalence of cardiac abnormalities on echocardiography will be compared between patients with COVID-19 and controls.
Measured: 3 months
Number of participants with abnormal blood biomarkers
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
Measured: 3 months
Major adverse cardiac and cerebrovascular events (MACCE)
MACCE is a composite of: Myocardial infarction; Unplanned coronary revascularization (PCI, CABG, thrombolysis) ; Heart failure hospitalization; Stroke (ischemic only); Arrhythmia requiring hospitalization; Cardiovascular death
Measured: 12 months
Prevalence of myocardial inflammation on PET/MRI
The prevalence of myocardial inflammation on PET/MRI will be evaluated in a subgroup of 50 patients recovered from COVID-19.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 Jul 2020
- Primary completion1 Apr 2022
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dinesh Thavendiranathan, University Health Network, Toronto
- Investigators
- Dinesh Thavendiranathan, Principal investigator, University Health Network, TorontoKate Hanneman, Principal investigator, University Health Network, TorontoKathryn Howe, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085262
- Sponsor's protocol ID
- COVID-19 Study 20-5453
- Status last verified
- May 2022
- First submitted
- 10 Sep 2021
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Disease and Outcomes Among Patients With SARS-CoV-2 (COVID-19) Infection During Hospital Admission and Post Discharge
- ClinicalTrials.gov ID
- NCT05085262
- Acronym / sponsor ID
- COVID-19 Study 20-5453
- Conditions
- COVID-19 Respiratory Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 251 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- Sep 2023 (estimated)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
COVID-19 and CVD: On March 11, 2020 the coronavirus disease of 2019 (COVID-19), which is caused by infection with SARS-CoV-2 virus, was declared a pandemic by the World Health Organization. Incredibly, >2,400,000 cases and >171,000 deaths have been reported globally as of April 21, 2020. While the overall case fatality is ~5%, the mortality rate is dramatically higher in selected populations, particularly in those with preexistent and/or new-onset cardiovascular disease (CVD)2. Early reports suggest that up to 20-28% of hospitalized patients with confirmed COVID-19 (COVID-19+) have evidence of cardiovascular injury, defined as troponin elevation with or without other cardiovascular manifestations such as ischemia, ventricular arrhythmias, and left ventricular dysfunction (LVD). While SARS-CoV-1 virus can directly infect the heart4, it is still not clear whether this is the case for SARS-CoV-2. Nevertheless, cardiovascular injury may result from indirect damage secondary to hypoxemia, sepsis, cytokine release, endothelial injury or from direct myocardial involvement. Regardless of the mechanism, early studies demonstrate that cardiovascular injury is associated with a 4-fold increased risk of death, independent of age, cardiovascular risk factors, preexistent CVD, non-CVD comorbidities, and ARDS (Acute Respiratory Distress Syndrome).The presence of CVD and cardiac injury appear to have a synergistic effect on adverse prognosis.5 However, the long-term consequences of this acute cardiovascular injury are not known, but are likely to be significant. Therefore, understanding early markers of cardiovascular injury, their association with adverse events (cardiovascular and non-cardiovascular) and post-discharge cardiovascular consequences of COVID-19 will allow better care of these patients.
Rationale for the study This study will address the above-mentioned knowledge gaps by focusing on patients with a broad spectrum of disease severity. It will include patients admitted to the hospital (sicker group) and those discharged from the emergency department (healthier group). It will focus on endothelial and cardiac blood biomarkers to facilitate early recognition of patients at risk for adverse events and characterize in-hospital and post-discharge cardiovascular sequelae of COVID-19. Ultimately, the intention is to identify patients at risk, reduce in-hospital and post-discharge adverse events, and determine the need for longer-term CVD prevention strategies and follow-up in survivors.
Endothelial cells (ECs) line every blood vessel within the human body and play a key role in CVD. During early COVID-19 infection ECs in the alveolar unit in the lung are likely injured due to the antiviral response of the lung cells. Furthermore, ECs also have receptors on their surface that can allow the virus to enter into the circulation and travel to other organs, including the heart. Therefore, damage to the endothelium, both directly or due to the body's antiviral inflammatory response, can contribute to cardiac injury and poor overall outcomes.
Cardiac injury can be identified by the release of cardiac markers in the blood such as troponin I and B-type natriuretic peptides, which can often be seen before overt heart dysfunction occurs. Therefore, we propose that measurement of both endothelial activation and cardiac-specific markers from patient's blood early after infection (i.e. at presentation) and during hospital admission, can serve as an indicator of early cardiovascular injury. Correlating these findings with abnormalities in cardiac functional tests as well as cardiovascular and non-cardiovascular adverse outcomes during admission and follow-up, will help us use these biomarkers to institute targeted prevention strategies.
Given that the majority of patients (>95%) who are infected with the virus survive, and cardiac injury during the infection is common, it is likely that there is significant unrecognized cardiac injury in survivors. This is often undetected during admission or in those discharged from the emergency department (ER) due to inability to perform complete cardiovascular assessment. To understand subclinical cardiovascular injury, all patients will be brought back 3-6 months for complete cardiac assessment using echocardiography, cardiac MRI, and bloodwork. This knowledge will enable strategies to prevent subsequent overt CVD events and to determine the need for further investigations and long-term follow-up in COVID-19 survivors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild Disease | – | Diagnostic Test: Bloodwork, Echocardiogram, PET/MRIThose assessed as an outpatient or discharged from the emergency department and never admitted elsewhere based on patient history |
| Moderate Disease | – | Diagnostic Test: Bloodwork, Echocardiogram, PET/MRIThose admitted but never requiring transfer to ICU or similar advanced care setting |
| Severe Disease | – | Diagnostic Test: Bloodwork, Echocardiogram, PET/MRIThose requiring admission to ICU or other advanced care settings (i.e. other Level 2 beds) |
| Control Group | – | Diagnostic Test: Bloodwork, Echocardiogram, MRIThose with a negative COVID-19 and no history of COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- COVID-19+ confirmed by RT-PCR (Reverse Transcriptase - Polymerase Chain Reaction).
- Age ≥ 18 years.
Key exclusion criteria (1 listed)
- 1. Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bloodwork, Echocardiogram, PET/MRIThe 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. | Diagnostic test | Mild Disease, Moderate Disease, Severe Disease |
| Bloodwork, Echocardiogram, MRIThe 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. | Diagnostic test | Control Group |
Primary outcome
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.
4 secondary outcomes
Prevalence of abnormalities on transthoracic echocardiography
Time frame: 3 months
Number of participants with abnormal blood biomarkers
Time frame: 3 months
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 12 months
Prevalence of myocardial inflammation on PET/MRI
Time frame: 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dinesh Thavendiranathan principal investigator
University Health Network, Toronto
Kate Hanneman principal investigator
University Health Network, Toronto
Kathryn Howe principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Respiratory Infection, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of abnormalities on cardiac MRI (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.