Study of Arrhythmia and ECG Abnormalities in Patients With COVID-19 (RYTHMO-COV)

June 22, 2021 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

196

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

  • France
      • Pessac, France, 33600
        • Bordeaux university hospital

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

All patients with SARS-CoV-2 infection followed by Bordeaux University Hospital for COVID-19

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SARS-CoV-2 infection
This group includes patients prospectively included during their follow-up at the Bordeaux University Hospital for COVID-19, as well as retrospectively included patients whose follow-up for COVID-19 has been completed.
Diagnostic test: ECG data analysis
Baseline ECG as well as follow-up ECG are analysed
Drug: Treatment data collect
Baseline treatment data as well as follow-up treatment data are collected
Biological: Biological check-up data collect
Baseline Biological check-up data as well as follow-up data are collected
Other: Collection of clinical events of interest
Clinical events of interest at the baseline as well as follow-up clinical events are collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of ECGs abnormalities in patients SARS-CoV-2 infection
Time Frame: Day 0
Percentage of ECGs with abnormalities
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 1 month
Rate of syncope during treatment
Time Frame: Baseline and 1 month
The number of syncope is measured during the treatment
Baseline and 1 month
Rate of cardiac death during treatment
Time Frame: Baseline and 1 month
The number of cardiac death is measured during the treatment
Baseline and 1 month
Rate of arrhythmia during treatment
Time Frame: Baseline and 1 month
The number of arrhythmia is measured during the treatment
Baseline and 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: frédéric Sacher, MD-PhD, University Hospital, Bordeaux

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)

June 2, 2020

Primary Completion (Actual)

December 2, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

June 22, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2020/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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