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Clinical Trials/NCT05729152
NCT05729152
Active, not recruiting
Not Applicable

LONGCOVID WP3 "Cardiovascular Events for a Long Time End of COVID 19 Infection "

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 sites in 1 country240 target enrollmentSeptember 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Disease
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
240
Locations
2
Primary Endpoint
Identify long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage in approximately 240 subjects who have been affected by COVID 19
Status
Active, not recruiting
Last Updated
3 years ago

Overview

Brief Summary

In the follow-up of partecipants with Covid-19 infection, persistence of cardiovascular symptoms is common. Studies on the acute phase of Covid-19 infection have demonstrated a significant prevalence of acute myocardial damage (15-44%), and imaging studies have confirmed the presence of structural changes in the pericardium and myocardium several months after the acute phase. The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.

Detailed Description

The study is a continuation of the "CARDICoVRISK" registry project ("Cardiovascular risk and effects ancillary effects of cardiology drug therapy during n-CoV-19 infection"), which collected data on alterations cardiovascular changes during the acute phase and shortly after the acute phase. The design of the current study is observational cross-sectional comparison with historical data. The study plans to enroll 240 patients hospitalized during the acute phase of COVID-19 infection. Enrollment of patients will be carried out in three separate centers. Enrolled patients will undergo a baseline assessment by history, objective examination, laboratory tests, ECG, 6-minute walking test and echocardiogram.

Registry
clinicaltrials.gov
Start Date
September 6, 2022
End Date
May 26, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pedicino Daniela

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility Criteria

Inclusion Criteria

  • partecipants with previous hospitalization for Covid-19 infection confirmed by pharyngeal molecular swab at least 12 months prior to enrollment;
  • adult partecipants between the ages of 18 and 90 years old;
  • signature of informed consent;

Exclusion Criteria

  • partecipants with poor echocardiographic acoustic window impairing the performance of the examination
  • partecipants with atrial fibrillation
  • partecipants with ischemic or nonischemic heart disease with known decreased systolic function of the left ventricle left

Outcomes

Primary Outcomes

Identify long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage in approximately 240 subjects who have been affected by COVID 19

Time Frame: 6 months

The main purpose of this study is to identify long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage. The anatomical and functional substrates of cardiovascular manifestations will be analyzed by basic and advanced echocardiographic technologies and, when appropriate, by MRI cardiac magnetic resonance imaging. Acute myocardial damage will be estimated by observation of troponin values already collected during acute infection as part of the CARDICoVRISK registry. Distant myocardial damage will be assessed by the assessments provided in the baseline visit.

Secondary Outcomes

  • Evaluate functional and anatomical abnormalities on diastolic dysfunction in 240 subjects who reported cardiac abnormalities following Covid infection(3 months)

Study Sites (2)

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