COVID-19 Echo Study

Sponsor
London North West Healthcare NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT05317962
Collaborator
(none)
251
1
17.6
14.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Transthoracic echocardiogram

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

Study Type:
Observational
Actual Enrollment :
251 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Cardiac Manifestations of COVID-19 in Patients Admitted to Hospital
Actual Study Start Date :
May 12, 2020
Actual Primary Completion Date :
Oct 31, 2021
Actual Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm Intervention/Treatment
COVID-19 positive patients admitted to hospital

Diagnostic Test: Transthoracic echocardiogram
Abbreviated transthoracic echocardiogram

Outcome Measures

Primary Outcome Measures

  1. Prevalence of cardiac abnormalities and relationship to admission to ICU [6 weeks from start of admission]

Secondary Outcome Measures

  1. Prevalence of cardiac abnormalities and relationship to need for mechanical ventilation [6 weeks from start of admission]

  2. Prevalence of cardiac abnormalities and relationship to death or discharge [6 weeks from start of admission]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 London North West University Healthcare NHS Trust Harrow United Kingdom HA1 3UJ

Sponsors and Collaborators

  • London North West Healthcare NHS Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
London North West Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT05317962
Other Study ID Numbers:
  • CRC/2020/002
First Posted:
Apr 8, 2022
Last Update Posted:
Apr 8, 2022
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by London North West Healthcare NHS Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022