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LONG-COVID: STUDIO DELLE MANIFESTAZIONI CARDIOVASCOLARI A LUNGO TERMINE MEDIANTE TECNICHE DI IMAGING

Sponsor
IRCCS San Raffaele (Other)
Overall Status
Completed
CT.gov ID
NCT05770336
Collaborator
Rete cardiologica IRCCS (Other)
120
Enrollment
1
Location
8.7
Actual Duration (Months)
13.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In the follow-up of patients with Covid-19 infection, persistence of cardiovascular symptoms is common. Studies of the acute phase of Covid-19 infection have shown 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.

    The study is a continuation of the project "Registry "CARDICoVRISK"" which collected data on cardiovascular changes during the acute phase and shortly after the acute phase. The study design is retrospective observational. The study plans to enroll 240 patients hospitalized during the acute phase of COVID-19 infection. Patients will be collected at three separate centers. Enrolled patients will undergo a baseline evaluation by history, physical examination, laboratory tests, ECG, 6-minute walking test and echocardiogram.

    If alterations in left ventricular or right ventricular systolic function are found, as per the standard clinical approach, a cardiac MRI examination will be evaluated.

    Identification of patients with cardiac changes is of paramount importance as they may benefit from early initiation of cardioprotective therapy and may need different follow-up strategies.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    STUDIO DELLE MANIFESTAZIONI CARDIOVASCOLARI A LUNGO TERMINE MEDIANTE TECNICHE DI IMAGING
    Actual Study Start Date :
    Mar 9, 2022
    Actual Primary Completion Date :
    Nov 30, 2022
    Actual Study Completion Date :
    Nov 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Patient with previous hospitalization for Covid-19 infection

    Outcome Measures

    Primary Outcome Measures

    1. Identify the long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage. [9 months]

      The main purpose of this study is to identify the 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient with previous hospitalization for Covid-19 infection confirmed by pharyngeal molecular swab

    • Adult patients between 18 and 90 years of age

    • Signature of informed consent

    Exclusion Criteria:

    • Patient with poor echocardiographic acoustic window impairing the performance of the examination

    • Patients with atrial fibrillation

    • Patients with ischemic or nonischemic heart disease with known decreased left ventricular systolic function

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCSS San Raffaele Milan Italy

    Sponsors and Collaborators

    • IRCCS San Raffaele
    • Rete cardiologica IRCCS

    Investigators

    • Study Director: Eustachio Agricola, MD, IRCCS San Raffaele

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Agricola Eustachio, PI, IRCCS San Raffaele
    ClinicalTrials.gov Identifier:
    NCT05770336
    Other Study ID Numbers:
    • LONG-COVID
    First Posted:
    Mar 15, 2023
    Last Update Posted:
    Mar 15, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pneumonia

    Study Results

    No Results Posted as of Mar 15, 2023