COVID-19 Echo Study

NCT ID: NCT05317962

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 251 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-12
• Study Completion Date: 2021-10-31

Brief Summary

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.

Conditions

Covid-19; Cardiac Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

COVID-19 positive patients admitted to hospital

Transthoracic echocardiogram

Intervention Type: DIAGNOSTIC_TEST

Abbreviated transthoracic echocardiogram

Interventions

Transthoracic echocardiogram

Abbreviated transthoracic echocardiogram

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age > 18 years old

2. Positive swab or serology for COVID-19

3. Referred for echocardiographic evaluation for clinical reasons

4. Willing and able to give assent

Exclusion Criteria

1. Known hypersensitivity to perflutren or known excipients in LUMINITY

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London North West Healthcare NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof Roxy Senior, MD

Role: PRINCIPAL_INVESTIGATOR

North West London University Healthcare NHS Trust

Locations

London North West University Healthcare NHS Trust

Harrow, , United Kingdom

Countries

United Kingdom

Other Identifiers

CRC/2020/002

Identifier Type: -

Identifier Source: org_study_id