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Completed

NCT Number: NCT04395664

Arrhythmias in Patients With COVID-19

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, Herlev & Gentofte Hospital

Copenhagen, Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

C3+ Holter Monitor

Device

ECG monitoring

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Registry information

Official study title

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

Acronym: ACOVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 20, 2020
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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