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NCT04395664 Clinical Trial

Arrhythmias in Patients With COVID-19

COVID-19 Clinical Trial

— ACOVID  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04395664
Other study ID # H-20021500
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 16, 2020
Est. completion date September 1, 2020

Study information
Verified date September 2020
Source Herlev and Gentofte Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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"

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• C3+ Holter Monitor
ECG monitoring

Locations
Country Name City State
Denmark Department of Cardiology, Herlev & Gentofte Hospital Copenhagen Hellerup

Sponsors (1)
Lead Sponsor Collaborator
Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis 4 months
Primary Incident intensive care unit admission during hospitalization and a confirmed COVID-19 diagnosis 4 months
Secondary Incident pulmonary embolism during hospitalization and a confirmed COVID-19 diagnosis 4 months
Secondary Incident cardiac arrest during hospitalization and a confirmed COVID-19 diagnosis 4 months
Secondary Incident hypoxic respiratory failure during hospitalization and a confirmed COVID-19 diagnosis 4 months
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