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Arrhythmias in Patients With COVID-19 (ACOVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04395664
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Morten Lamberts, Herlev and Gentofte Hospital

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.

Condition or disease Intervention/treatment
COVID-19 Device: C3+ Holter Monitor

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The ACOVID-19 Study - A Prospective Cohort Study Investigating the Acute Effect of COVID-19 on the Heart by Continuous ECG Monitoring
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : April 1, 2021

Intervention Details:
  • Device: C3+ Holter Monitor
    ECG monitoring


Primary Outcome Measures :
  1. In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis [ Time Frame: 4 months ]
  2. Incident intensive care unit admission during hospitalization and a confirmed COVID-19 diagnosis [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Incident pulmonary embolism during hospitalization and a confirmed COVID-19 diagnosis [ Time Frame: 4 months ]
  2. Incident cardiac arrest during hospitalization and a confirmed COVID-19 diagnosis [ Time Frame: 4 months ]
  3. Incident hypoxic respiratory failure during hospitalization and a confirmed COVID-19 diagnosis [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In.patients from hospitals of the greater Copenhagen area
Criteria

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"

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395664


Contacts
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Contact: Morten Kjøbek Lamberts, MD, PhD +4522434186 morten.kjoebek.lamberts@regionh.dk

Locations
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Denmark
Department of Cardiology, Herlev & Gentofte Hospital Recruiting
Copenhagen, Hellerup, Denmark, 2900
Contact: Morten Kjøbæk Lamberts, MD, PhD         
Sponsors and Collaborators
Herlev and Gentofte Hospital

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Responsible Party: Morten Lamberts, Associate Professor and Research Director, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT04395664    
Other Study ID Numbers: H-20021500
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No