Covid-19NCT05317962
COVID-19 Echo Study
An observational study of Covid-19 and Cardiac Disease, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Investigation of the cardiac manifestations of COVID-19 in patients admitted to hospital Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, Cardiac Disease
- What is being tested?
- Transthoracic echocardiogram
- How many people
- 251 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 May 2020to 31 Oct 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the cardiology department at Northwick Park Hospital to have a transthoracic echocardiogram who have also tested positive for COVID-19,
Who may be able to join
- Age > 18 years old
- Positive swab or serology for COVID-19
- Referred for echocardiographic evaluation for clinical reasons
- Willing and able to give assent
Who cannot join
- 1. Known hypersensitivity to perflutren or known excipients in LUMINITY
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London North West University Healthcare NHS Trust
Harrow, HA1 3UJ
About this study
Official title: Cardiac Manifestations of COVID-19 in Patients Admitted to Hospital
Investigation of the cardiac manifestations of COVID-19 in patients admitted to hospital
Read the detailed description
The COVID-19 disease (caused by SARS-CoV-2) predominantly affects the lungs causing a pneumonia which can become severe and lead to death via a severe inflammatory response in the lungs for which patients require admission to intensive care units (ICU) and artificial ventilation of their lungs. However, early reports from China have documented an element of injury to the heart present in up to 20% of patients. They have also documented patients who have died on ICU from heart injury rather than lung injury in COVID-19 positive patients. There are increasing numbers of reports of patients with COVID-19 having significant inflammation of the heart. What is not known is the prevalence of significant inflammation of the heart secondary to the SARS-CoV-2 and also what the significance of the injury to the heart shown in 20% of patients through blood tests really represents. That is to say is the injury significant to the outcome of the patient?
In order to investigate this, it is proposed to conduct a heart scan in COVID-19 positive patients in hospital to determine what form of heart injury is caused by the disease as well as determining it's prevalence and whether a heart scan helps in risk stratifying the patient in terms of outcome. If it is found that there is a significant amount of heart injury done by the SARS-CoV-2 and it can be determined this at an early stage with a heart scan it may be possible to start a more aggressive strategy for the patient's management in hospital to reduce the chance of death. Alternatively, if it is found that the incidence of heart injury is low and a heart scan makes no difference to the management of the patient, medical teams can be advised of this.
- Conditions
- Covid-19, Cardiac Disease
- Being tested
- Transthoracic echocardiogram
- Keywords
- Echocardiography
- Medical subject headings
- COVID-19, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiogramDiagnostic test
Abbreviated transthoracic echocardiogram
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive patients admitted to hospital | Not described Receives: Diagnostic Test: Transthoracic echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cardiac abnormalities and relationship to admission to ICU
Measured: 6 weeks from start of admission
Secondary outcomes (2)
Prevalence of cardiac abnormalities and relationship to need for mechanical ventilation
Measured: 6 weeks from start of admission
Prevalence of cardiac abnormalities and relationship to death or discharge
Measured: 6 weeks from start of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start12 May 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
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.
- 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
- Cross-sectional
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Roxy Senior, MD, Principal investigator, North West London University Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317962
- Sponsor's protocol ID
- CRC/2020/002
- Status last verified
- Apr 2020
- First submitted
- 9 Sep 2020
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Manifestations of COVID-19 in Patients Admitted to Hospital
- ClinicalTrials.gov ID
- NCT05317962
- Acronym / sponsor ID
- CRC/2020/002
- Conditions
- Covid-19, Cardiac Disease
- Keywords
- Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 8 Apr 2022 (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.
Investigation of the cardiac manifestations of COVID-19 in patients admitted to hospital
Detailed description
The COVID-19 disease (caused by SARS-CoV-2) predominantly affects the lungs causing a pneumonia which can become severe and lead to death via a severe inflammatory response in the lungs for which patients require admission to intensive care units (ICU) and artificial ventilation of their lungs. However, early reports from China have documented an element of injury to the heart present in up to 20% of patients. They have also documented patients who have died on ICU from heart injury rather than lung injury in COVID-19 positive patients. There are increasing numbers of reports of patients with COVID-19 having significant inflammation of the heart. What is not known is the prevalence of significant inflammation of the heart secondary to the SARS-CoV-2 and also what the significance of the injury to the heart shown in 20% of patients through blood tests really represents. That is to say is the injury significant to the outcome of the patient?
In order to investigate this, it is proposed to conduct a heart scan in COVID-19 positive patients in hospital to determine what form of heart injury is caused by the disease as well as determining it's prevalence and whether a heart scan helps in risk stratifying the patient in terms of outcome. If it is found that there is a significant amount of heart injury done by the SARS-CoV-2 and it can be determined this at an early stage with a heart scan it may be possible to start a more aggressive strategy for the patient's management in hospital to reduce the chance of death. Alternatively, if it is found that the incidence of heart injury is low and a heart scan makes no difference to the management of the patient, medical teams can be advised of this.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive patients admitted to hospital | – | Diagnostic Test: Transthoracic echocardiogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the cardiology department at Northwick Park Hospital to have a transthoracic echocardiogram who have also tested positive for COVID-19,
Key inclusion criteria (4 listed)
- Age > 18 years old
- Positive swab or serology for COVID-19
- Referred for echocardiographic evaluation for clinical reasons
- Willing and able to give assent
Key exclusion criteria (1 listed)
- 1. Known hypersensitivity to perflutren or known excipients in LUMINITY
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 |
|---|---|---|
| Transthoracic echocardiogramAbbreviated transthoracic echocardiogram | Diagnostic test | COVID-19 positive patients admitted to hospital |
Primary outcome
Prevalence of cardiac abnormalities and relationship to admission to ICU
Time frame: 6 weeks from start of admission
2 secondary outcomes
Prevalence of cardiac abnormalities and relationship to need for mechanical ventilation
Time frame: 6 weeks from start of admission
Prevalence of cardiac abnormalities and relationship to death or discharge
Time frame: 6 weeks from start of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Prof Roxy Senior, MD principal investigator
North West London University Healthcare NHS Trust
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 and Cardiac Disease, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 8 Apr 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 cardiac abnormalities and relationship to admission to ICU (time frame: 6 weeks from start of admission). 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 8 Apr 2022.