- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04395664
Arrhythmias in Patients With COVID-19 (ACOVID)
September 6, 2020 updated by: Morten Lamberts, Herlev and Gentofte Hospital
The ACOVID-19 Study - A Prospective Cohort Study Investigating the Acute Effect of COVID-19 on the Heart by Continuous ECG Monitoring
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 Overview
Study Type
Observational
Enrollment (Actual)
1000
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
-
-
Hellerup
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Copenhagen, Hellerup, Denmark, 2900
- Department of Cardiology, Herlev & Gentofte Hospital
-
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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
In.patients from hospitals of the greater Copenhagen area
Description
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 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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis
Time Frame: 4 months
|
4 months
|
Incident intensive care unit admission during hospitalization and a confirmed COVID-19 diagnosis
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incident pulmonary embolism during hospitalization and a confirmed COVID-19 diagnosis
Time Frame: 4 months
|
4 months
|
Incident cardiac arrest during hospitalization and a confirmed COVID-19 diagnosis
Time Frame: 4 months
|
4 months
|
Incident hypoxic respiratory failure during hospitalization and a confirmed COVID-19 diagnosis
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 16, 2020
Primary Completion (ACTUAL)
September 1, 2020
Study Completion (ACTUAL)
September 1, 2020
Study Registration Dates
First Submitted
May 19, 2020
First Submitted That Met QC Criteria
May 19, 2020
First Posted (ACTUAL)
May 20, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 9, 2020
Last Update Submitted That Met QC Criteria
September 6, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-20021500
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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