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

NCT06674278 | Not Yet Recruiting

• 1 other identifier: BE-2-40
• Study Type: observational
• Target: 215
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post COVID-19; Ventricular Repolarization; Arrhythmias; Impedance Cradiography

Outcome Measures

Primary Outcomes (6)

• 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.

  The arrhythmias in medical records and those found during Holter monitoring will be accounted. Changes in ECG repolarization parameters are considered present if any of the following are present: prolonged QTc, prolonged Tpec, increased QRS/T angle.

  In two weeks (14 days) after the enrollment.

• Frequency of ischaemic cardiovascular events in 2 years after the disease, comparing COVID-19 patients with changes in ECG repolarization parameters and COVID-19 patients without these changes.

  The ischaemic events in medical records will be accounted. Changes in ECG repolarization parameters are considered present if any of the following are present: prolonged QTc, prolonged Tpec, increased QRS/T angle.

  In two weeks (14 days) after the enrollment.

• ECG QTc (measured in milliseconds) during the COVID-19 and after 2 years in individuals who have recovered from COVID-19.

  In two weeks (14 days) after the enrollment.

• ECG Tpec (measured in milliseconds) during the COVID-19 and after 2 years in individuals who have recovered from COVID-19.

  Tpec = Tpeak-to-Tend interval corrected for heart rate

  In two weeks (14 days) after the enrollment.

• ECG Tpec/QTc during the COVID-19 and after 2 years in individuals who have recovered from COVID-19.

  In two weeks (14 days) after the enrollment.

• Changes in ECG QRS-T angle during the COVID-19 and after 2 years in individuals who have recovered from COVID-19.

  In two weeks (14 days) after the enrollment.

Study Arms (2)

Patients with changes in ECG repolarization parameters and arrhythmias during acute COVID-19

Patients without changes in ECG repolarization parameters and arrhythmias during acute COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will consist of patients who have had COVID-19 and were treated in the LSMU Kaunas Hospital inpatient units two years ago (starting 2024 January 1st). The invitation will be communicated through family doctors to attend a cardiologist's consultation at the LSMU Kaunas Hospital two years after their hospitalization. Those who agree to participate and meet the inclusion criteria and do not have any exclusion criteria will be enrolled. Enrollment will continue until the required sample size is reached.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jonas Jucevičius

CONTACT

+370 37 306093; jonas.jucevicius@lsmu.lt

Eglė Kalinauskienė, Professor

CONTACT

+370 37 306093; egle.kalinauskiene@lsmu.lt

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, Assistant lecturer.

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: November 5, 2024
• Study Start: November 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 5, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Starting 6 months after publication