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Clinical Trials/NCT04395664
NCT04395664CompletedNot Applicable

The ACOVID-19 Study - A Prospective Cohort Study Investigating the Acute Effect of COVID-19 on the Heart by Continuous ECG Monitoring

Herlev and Gentofte Hospital1 site in 1 country1,000 target enrollmentStarted: April 16, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,000
Locations
1
Primary Endpoint
Incident intensive care unit admission during hospitalization and a confirmed COVID-19 diagnosis

Study Overview

Brief Summary

The study is a prospective clinical cohort study of consecutive patients hospitalized at all hospitals of greater Copenhagen with a laboratory confirmed diagnosis of COVID-19. The investigators aim to examine if continuous ECG monitoring can be used to understand the contribution of COVID-19 infection in the acute phase to the development of cardiac arrhythmias, especially focusing on cardiovascular outcomes. In all patients included, the investigators aim to examine if continuous ECG monitoring - alone and in combination with biomarkers - can be used to detect early signs of cardiac complications and predict long-term risk of cardiovascular morbidity and mortality following COVID-19 infection.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All patients hospitalized at hospitals of greater Copenhagen area and Zealand with a laboratory confirmed diagnosis of COVID-19 > 18 years of age.

Exclusion Criteria

  • Persons not able to cooperate
  • Persons unable to understand and sign "informed consent"

Outcomes

Primary Outcomes

Incident intensive care unit admission during hospitalization and a confirmed COVID-19 diagnosis

Time Frame: 4 months

In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis

Time Frame: 4 months

Secondary Outcomes

  • Incident pulmonary embolism during hospitalization and a confirmed COVID-19 diagnosis(4 months)
  • Incident cardiac arrest during hospitalization and a confirmed COVID-19 diagnosis(4 months)
  • Incident hypoxic respiratory failure during hospitalization and a confirmed COVID-19 diagnosis(4 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Morten Lamberts

Associate Professor and Research Director

Herlev and Gentofte Hospital

Study Sites (1)

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