Cardiovascular Events for a Long Time End of COVID 19 Infection

NCT ID: NCT05729152

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-06

Study Completion Date

2023-05-26

Brief Summary

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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

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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.

Conditions

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Myocardial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Sample blood

Partecipants will undergo a baseline assessment by history, objective examination, laboratory tests, ECG, 6-minute walking test and echocardiogram

Intervention Type OTHER

Other Intervention Names

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Objective examination, laboratory tests, ECG, 6-minute walking test and echocardiogram

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Pedicino Daniela

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istituto Auxologico Italiano IRCSS Ospedale San Luca

Milan, , Italy

Site Status

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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5031

Identifier Type: -

Identifier Source: org_study_id

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