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

Completed

• Conditions: SARS-CoV-2 Infection; Arrhythmia
• Interventions: Diagnostic Test: ECG data analysis; Drug: Treatment data collect; Biological: Biological check-up data collect; Other: Collection of clinical events of interest

• Registration Number: NCT04937621
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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.

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 Timeline

• Study Start: 2020-06-02
• Primary Completion: 2020-12-02
• Study Completion: 2020-12-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-22
• Last Update Submitted: 2021-06-22
• Study First Posted: 2021-06-24
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 infection	Treatment data collect	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.
SARS-CoV-2 infection	Collection of clinical events of interest	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.
SARS-CoV-2 infection	ECG data analysis	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.
SARS-CoV-2 infection	Biological check-up data collect	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.

Primary Outcome Measures

Name	Time	Method
Proportion of ECGs abnormalities in patients SARS-CoV-2 infection	Day 0	Percentage of ECGs with abnormalities

Secondary Outcome Measures

Name	Time	Method
Rate of arrhythmia during treatment	Baseline and 1 month	The number of arrhythmia is measured during the treatment
Evolution of PR, QRS and cQT interval	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
Rate of syncope during treatment	Baseline and 1 month	The number of syncope is measured during the treatment
Rate of cardiac death during treatment	Baseline and 1 month	The number of cardiac death is measured during the treatment

Trial Locations

Locations (1)

Bordeaux University Hospital; 🇫🇷 Pessac, France