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OpenTrials
Completed

NCT Number: NCT04937621

Study of Arrhythmia and ECG Abnormalities in Patients With COVID-19

Cardiac involvement has been described in Severe Acute Respiratory Syndrome - Coronavirus-2 (SARS-CoV-2) infection. Although there are no approved drugs to prevent or treat SARS-CoV-2 infection at present time, several medications used have the potential to increase QT interval and eventually provoke torsades de pointe. The investigators therefore create a study that include all patients with SARS-CoV-2 infection having an electrocardiogram (ECG). The investigators evaluate the percentage of patients with ECG abnormalities, describe the abnormalities and evaluate the occurrence of syncope, ventricular arrhythmia and corrected QT (cQT) interval modification in patients receiving treatment.

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac COVID-19 Cardiac Conduction System Disease Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Heart Diseases Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV-2 Infection Tachycardia Tachycardia, Ventricular Torsades de Pointes Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bordeaux University Hospital

Pessac, 33600, France

About this study

In patients with SARS-CoV-2 infection, the investigators analyze baseline ECG as well as follow-up ECG. Patients followed by Bordeaux University Hospital for COVID-19 can be included. ECG are digitized in the computerized patient file (DxCARE) for further analysis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over 18 years of both gender,
  • Followed by Bordeaux University Hospital for SARS-CoV-2 infection with a cardiac monitoring or ECG realized.
  • Non opposition expressed.

Exclusion criteria

  • Minor,
  • Inability to understand the study

Treatment and study plan

ECG data analysis

Diagnostic Test

Baseline ECG as well as follow-up ECG are analysed

Treatment data collect

Drug

Baseline treatment data as well as follow-up treatment data are collected

Biological check-up data collect

Biological

Baseline Biological check-up data as well as follow-up data are collected

Collection of clinical events of interest

Other

Clinical events of interest at the baseline as well as follow-up clinical events are collected

Primary outcomes

  1. Proportion of ECGs abnormalities in patients SARS-CoV-2 infection

    Time frame: Day 0

    Percentage of ECGs with abnormalities

Secondary outcomes

  1. Evolution of PR, QRS and cQT interval

    Time frame: Baseline and 1 month

    The evolution of interval is measured in seconds for patients receiving drugs interfering with cardiac electrophysiology for SARS-CoV-2 infection

  2. Rate of syncope during treatment

    Time frame: Baseline and 1 month

    The number of syncope is measured during the treatment

  3. Rate of cardiac death during treatment

    Time frame: Baseline and 1 month

    The number of cardiac death is measured during the treatment

  4. Rate of arrhythmia during treatment

    Time frame: Baseline and 1 month

    The number of arrhythmia is measured during the treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: RYTHMO-COV

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2021
Registry last updated
Jun 24, 2021

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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