COVID-19NCT04355884
Opportunistic Screening for Asymptomatic Left Ventricular Dysfunction in Coronavirus Disease 2019 (COVID19) Survivors
An observational study of COVID-19, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Coronavirus Disease 2019 (COVID-19) emerged in December 2019, and in mere few months has resulted in a pandemic of viral pneumonia. Substantial proportion of patients with COVID-19 have biochemical evidence of myocardial injuries during the acute phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Standard 12-lead ECG, NT-proBNP, echocardiography
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Apr 2020to 1 May 2020
- 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
- Adult, Older adult
Study population: Survivors of PCR-confirmed COVID-19 2-6 weeks after hospital discharge with 2 consecutive negative PCR for SARS-CoV-2 and without pre-existing heart failure, left ventricular dysfunction, and/or atrial fibrillation
Who may be able to join
- Survivors of PCR-confirmed COVID-19
- 2-6 weeks after hospital discharge with 2 consecutive negative polymerase chain reaction (PCR) for severe acute respiratory syndrome (SARS) coronavirus (CoV)-2.
Who cannot join
- Pre-existing heart failure
- Pre-existing left ventricular systolic dysfunction (left ventricular ejection fraction < 50%)
- Pre-existing atrial fibrillation
- Failure to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opportunistic Screening for Asymptomatic Left Ventricular Dysfunction in COVID-19 Survivors
Coronavirus Disease 2019 (COVID-19) emerged in December 2019, and in mere few months has resulted in a pandemic of viral pneumonia. Substantial proportion of patients with COVID-19 have biochemical evidence of myocardial injuries during the acute phase. Possible mechanisms including acute coronary events, cytokine storm, and COVID-19 related myocarditis, have been postulated for the cardiac involvement in COVID-19. It is uncertain whether COVID-19 survivors are at risk cardiac dysfunction including cardiac arrhythmia and heart failure.
The prospective screening study aims to evaluate the possible latent effects from COVID-19 in COVID-19 survivors. COVID-19 survivors 4-6 weeks after hospital discharge will be recruited from the Infectious Disease clinic, Queen Mary Hospital with standard 12-lead electrocardiogram, serum troponin, NT-proBNP, and standard transthoracic echocardiogram.
The outcome measures include (1) new onset cardiac arrhythmia, (2) N Terminal (NT)-proBNP elevation above the diagnostic range of heart failure, and (3) newly detected left ventricular dysfunction.
Read the detailed description
Coronavirus Disease 2019 (COVID-19) emerged in December 2019, and in mere few months has resulted in a pandemic of viral pneumonia. As of April 2020, over 2 million populations were infected and more than 150,000 deaths globally. In the initial report from Wuhan, China, up to 27.8% COVID19 patients had an elevated troponin level indicating myocardial damage during the index hospitalization for COVID. This is nearly 10-folded higher than that of other common viral illnesses such as influenza (2.9%). Possible mechanisms including acute coronary events, cytokine storm, and COVID-19 related myocarditis, have been postulated for the cardiac involvement in COVID-19. Nonetheless, it is unknown whether COVID-19 survivors are at risk cardiac dysfunction including cardiac arrhythmia and heart failure.
The prospective screening study aims to evaluate the possible latent effects from COVID-19 in COVID-19 survivors. COVID-19 survivors 4-6 weeks after hospital discharge will be recruited from the Infectious Disease clinic, Queen Mary Hospital. Standard 12-lead electrocardiogram, serum troponin, NT-proBNP, and standard transthoracic echocardiogram will be performed for COVID-19 survivors.
The outcome measures include (1) new onset cardiac arrhythmia, (2) NT-proBNP elevation above the diagnostic range of heart failure, and (3) newly detected left ventricular dysfunction.
- Conditions
- COVID-19
- Being tested
- Standard 12-lead ECG, NT-proBNP, echocardiography
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard 12-lead ECG, NT-proBNP, echocardiographyDiagnostic test
Cardiac assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
New-onset cardiac arrhythmia
Atrial fibrillation, conduction block
Measured: At the time of screening
Elevation of NT-proBNP
Elevated NT-proBNP level above the age-specific diagnostic threshold of heart failure
Measured: At the time of screening
Left ventricular dysfunction
Left ventricular systolic function
Measured: At the time of screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start20 Apr 2020 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355884
- Sponsor's protocol ID
- COVID_LVD_SCREEN
- Status last verified
- Apr 2020
- First submitted
- 19 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- 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 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunistic Screening for Asymptomatic Left Ventricular Dysfunction in COVID-19 Survivors
- ClinicalTrials.gov ID
- NCT04355884
- Acronym / sponsor ID
- COVID_LVD_SCREEN
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 20 Apr 2020 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 21 Apr 2020 (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.
Coronavirus Disease 2019 (COVID-19) emerged in December 2019, and in mere few months has resulted in a pandemic of viral pneumonia. Substantial proportion of patients with COVID-19 have biochemical evidence of myocardial injuries during the acute phase. Possible mechanisms including acute coronary events, cytokine storm, and COVID-19 related myocarditis, have been postulated for the cardiac involvement in COVID-19. It is uncertain whether COVID-19 survivors are at risk cardiac dysfunction including cardiac arrhythmia and heart failure.
The prospective screening study aims to evaluate the possible latent effects from COVID-19 in COVID-19 survivors. COVID-19 survivors 4-6 weeks after hospital discharge will be recruited from the Infectious Disease clinic, Queen Mary Hospital with standard 12-lead electrocardiogram, serum troponin, NT-proBNP, and standard transthoracic echocardiogram.
The outcome measures include (1) new onset cardiac arrhythmia, (2) N Terminal (NT)-proBNP elevation above the diagnostic range of heart failure, and (3) newly detected left ventricular dysfunction.
Detailed description
Coronavirus Disease 2019 (COVID-19) emerged in December 2019, and in mere few months has resulted in a pandemic of viral pneumonia. As of April 2020, over 2 million populations were infected and more than 150,000 deaths globally. In the initial report from Wuhan, China, up to 27.8% COVID19 patients had an elevated troponin level indicating myocardial damage during the index hospitalization for COVID. This is nearly 10-folded higher than that of other common viral illnesses such as influenza (2.9%). Possible mechanisms including acute coronary events, cytokine storm, and COVID-19 related myocarditis, have been postulated for the cardiac involvement in COVID-19. Nonetheless, it is unknown whether COVID-19 survivors are at risk cardiac dysfunction including cardiac arrhythmia and heart failure.
The prospective screening study aims to evaluate the possible latent effects from COVID-19 in COVID-19 survivors. COVID-19 survivors 4-6 weeks after hospital discharge will be recruited from the Infectious Disease clinic, Queen Mary Hospital. Standard 12-lead electrocardiogram, serum troponin, NT-proBNP, and standard transthoracic echocardiogram will be performed for COVID-19 survivors.
The outcome measures include (1) new onset cardiac arrhythmia, (2) NT-proBNP elevation above the diagnostic range of heart failure, and (3) newly detected left ventricular dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Survivors of PCR-confirmed COVID-19 2-6 weeks after hospital discharge with 2 consecutive negative PCR for SARS-CoV-2 and without pre-existing heart failure, left ventricular dysfunction, and/or atrial fibrillation
Key inclusion criteria (2 listed)
- Survivors of PCR-confirmed COVID-19
- 2-6 weeks after hospital discharge with 2 consecutive negative polymerase chain reaction (PCR) for severe acute respiratory syndrome (SARS) coronavirus (CoV)-2.
Key exclusion criteria (4 listed)
- Pre-existing heart failure
- Pre-existing left ventricular systolic dysfunction (left ventricular ejection fraction < 50%)
- Pre-existing atrial fibrillation
- Failure to provide informed consent
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 |
|---|---|---|
| Standard 12-lead ECG, NT-proBNP, echocardiographyCardiac assessment | Diagnostic test | – |
Primary outcome
New-onset cardiac arrhythmia
Time frame: At the time of screening
Atrial fibrillation, conduction block
Elevation of NT-proBNP
Time frame: At the time of screening
Elevated NT-proBNP level above the age-specific diagnostic threshold of heart failure
Left ventricular dysfunction
Time frame: At the time of screening
Left ventricular systolic function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- 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.
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, run by The University of Hong Kong at 1 site in Hong Kong.
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 4 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 24 Apr 2020. 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 Hong Kong. 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?
Contact Chung Wah SIU, MD (852-2255-4694, cwdsiu@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New-onset cardiac arrhythmia (time frame: At the time of screening). The study lists 3 primary outcomes in all. 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 24 Apr 2020.