QT-COVID-19: Effects on the Qt Interval of COVID-19 Coronavirus Infection

Sponsor
Matilde Zaballos (Other)
Overall Status
Unknown status
CT.gov ID
NCT04422535
Collaborator
(none)
80
1
6.1
13.1

Study Details

Study Description

Brief Summary

The present study aims to evaluate the impact of COVID-19 disease and its treatment on ventricular repolarization, assessed by measuring the QTc interval, in patients admitted to the critical care unit.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Coronavirus infection of Severe Acute Respiratory Syndrome COVID-2 is characterized by a broad clinical spectrum ranging from asymptomatic infection, mild upper respiratory tract disease and severe viral pneumonia with respiratory failure and even death, with many patients hospitalized with pneumonia. In addition, the infection can have a direct impact on cardiovascular disease including the development of arrhythmias, although the exact incidence is not known. Treatments administered for COVID-19 infection have the potential to produce adverse cardiovascular effects including prolongation of the QT interval and development of arrhythmias.

    Relevant clinical data that may affect the QT interval and specifically the medication the patient has received will be recorded. The specific treatment administered for COVID-19 will be recorded as the concomitant medication of the critical patient that may have an impact on the QT interval. Analytical data will also be collected on plasma levels of ions such as potassium, calcium and magnesium, blood gases, renal and hepatic function parameters and cardiac markers.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Observational Study to Evaluate the Effects on the Qt Interval of COVID-19 Coronavirus Infection in Critically Ill Patients
    Actual Study Start Date :
    May 29, 2020
    Anticipated Primary Completion Date :
    Sep 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Critical care patients

    Patients admitted to critical care units for COVID-19, where ECG records and relevant clinical information are available to assess the impact of the disease and its concomitant treatment on electrocardiographic parameters of ventricular repolarization

    Outcome Measures

    Primary Outcome Measures

    1. Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection [through study completion, an average of 1 year]

      The QT interval measurement will be performed on the available 12-lead ECG from the medical record. The QT interval will be measured according to the recommendations of the scientific societies of cardiology: it is considered from the beginning of the activation of the ventricular myocardium and the end of its repolarization, which are represented in the ECG respectively by the beginning of the QRS and the end of the T wave. Ideally, the QT interval should be measured in Q-wave leads in DII and V5. An average value of 3 heart cycles (beats) should be recorded. Two researchers to control inter-observer variability will perform the measurement.

    Secondary Outcome Measures

    1. incidence of arrhythmias and impact of the COVI-drugs administered on QT interval [through study completion, an average of 1 year]

      To assess the incidence of arrhythmias in critically ill patients with COVID-19 infection admitted to critical patient units. To evaluate the impact of the association of drugs administered for the treatment of COVID-19 infection in critically ill patients in the QT interval.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients admitted to intensive care units for COVID-19 infection with an ECG record
    Exclusion Criteria:
    • Patients in critical care unit without COVID-19 infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Servicio de Anestesia, Hospital General Universitario Gregorio Marañon Madrid Spain 28007

    Sponsors and Collaborators

    • Matilde Zaballos

    Investigators

    • Study Chair: Javier Hortal, MD PhD, Hospital Universitario Gregorio Marañon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matilde Zaballos, specialist physician at Anesthesiology Department, Hospital General Universitario Gregorio Marañon
    ClinicalTrials.gov Identifier:
    NCT04422535
    Other Study ID Numbers:
    • QT-COVID-19
    First Posted:
    Jun 9, 2020
    Last Update Posted:
    Jun 9, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Matilde Zaballos, specialist physician at Anesthesiology Department, Hospital General Universitario Gregorio Marañon
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 9, 2020