COVID-19 Echo Study

April 7, 2022 updated by: London North West Healthcare NHS Trust

Cardiac Manifestations of COVID-19 in Patients Admitted to Hospital

Investigation of the cardiac manifestations of COVID-19 in patients admitted to hospital

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

251

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Harrow, United Kingdom, HA1 3UJ
        • London North West University Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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,

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 positive patients admitted to hospital
Diagnostic test: Transthoracic echocardiogram
Abbreviated transthoracic echocardiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of cardiac abnormalities and relationship to admission to ICU
Time Frame: 6 weeks from start of admission
6 weeks from start of admission

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of cardiac abnormalities and relationship to need for mechanical ventilation
Time Frame: 6 weeks from start of admission
6 weeks from start of admission
Prevalence of cardiac abnormalities and relationship to death or discharge
Time Frame: 6 weeks from start of admission
6 weeks from start of admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London North West Healthcare NHS Trust

Investigators

  • Principal Investigator: Prof Roxy Senior, MD, North West London University Healthcare NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 12, 2020

Primary Completion (ACTUAL)

October 31, 2021

Study Completion (ACTUAL)

October 31, 2021

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

April 7, 2022

First Posted (ACTUAL)

April 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC/2020/002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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