NCT06674278Not yet recruitingNot Applicable

Changes in Electrocardiographic (ECG) Ventricular Repolarization and Transthoracic Impedance Cardiography (ICG) Parameters in Patients with COVID-19 and After the Disease: Persistence and Prognostic Significance of These Changes

Lithuanian University of Health Sciences0 sites215 target enrollmentStarted: November 2024Last updated: November 5, 2024

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Not yet recruiting
Sponsor: Lithuanian University of Health Sciences
Enrollment: 215
Primary Endpoint: Frequency of arrhythmias (sinus, supraventricular, ventricular) in participants in 2 years after the disease, comparing COVID-19 patients with changes in ECG repolarization parameters and COVID-19 patients without these changes.

Study Overview Study Design Eligibility Criteria Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

The aim of this study is to determine the relationship between changes in resting electrocardiography (ECG) ventricular repolarization parameters, transthoracic impedance cardiography (ICG) parameters, and COVID-19, to assess the relationship between ECG changes after COVID-19 and heart rhythm disorders (arrhythmias), cardiovascular events (the onset and exacerbation of cardiovascular diseases), the persistence of changes two years after the illness, and to identify prognostic ventricular repolarization parameters in patients with and after COVID-19.

It is expected that the results obtained during the study will help predict long-term cardiovascular complications in these patients, aiming to prevent them by providing recommendations for the long-term monitoring of individuals who have recovered from COVID-19. Additionally, the investigators hope to propose a new ECG ventricular repolarization parameter that could be used in the future for prognostic assessment in patients with other diseases as well.

Detailed Description

Purpose:

To find the relation between changes in resting electrocardiography (ECG) ventricular repolarization parameters and the consequences of COVID-19. To assess these parameters connection with arrhythmias and overall cardiovascular events and transthoracic impedance cardiography (ICG) parameters, to evaluate the persistence of changes over a 2-year period after the illness, and to identify prognostic ventricular repolarization and ECG parameters in COVID-19 patients.

Goals of the study:

To identify the most common differences in ECG ventricular repolarization parameters among COVID-19 patients who experienced arrhythmias and/or other cardiovascular events within 2 years of hospital discharge, compared to those who did not have arrhythmias and/or other cardiovascular events.
To assess the persistence of changes in ECG ventricular repolarization parameters 2 years after hospital discharge.
To identify and determine the differences in ICG parameters among individuals who have recovered from COVID-19 2 years after their hospital discharge.
To find the most appropriate prognostic ECG criteria for monitoring recommendations for patients who have recovered from COVID-19.

Duration of the study: the study is estimated to take 3 years (from 2024 11 to 2027 09). Each enrolled participant participates in study for 2 days (a little more than 24 hours total): one hour is allocated for the examination (taking medical history, objective examination, ECG, echocardiography, placing the Holter monitoring device, and performing the ECG) and the following day for about 5 minutes when participant returns for the removal of the Holter monitoring device.

Study Design

Study Type: Observational
Observational Model: Other
Time Perspective: Prospective

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Patient was hospitalized and treated in LUHS Kaunas Hospital for acute COVID-19 2 years ago (starting from 2022 January 1st).
•During hospitalization COVID-19 was verified with PCR test from nasopharyngeal swab.

Exclusion Criteria

•COVID-19 was not verified with PCR test from nasopharyngeal swab.
•Patients who are unable to give informed consent for participation in study; vulnerable individuals: students if their participation is related to their studies, employees of healthcare institutions subordinate to the researcher, residents of social care institutions, and soldiers during their active military service.
•Patients with an implanted pacemaker or cardioverter-defibrillator.
•Patients whose permanent residence is not in Lithuania and who are not Lithuanian citizens.
•Patients for whom it is not possible to perform ECG and ICG tests due to various circumstances.
•Pregnant individuals (including individuals who were pregnant during the disease).

Outcomes

Primary Outcomes

Frequency of arrhythmias (sinus, supraventricular, ventricular) in participants in 2 years after the disease, comparing COVID-19 patients with changes in ECG repolarization parameters and COVID-19 patients without these changes.