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Cardiovascular and Psychological Consequences of COVID-19

Sponsor
Istituti Clinici Scientifici Maugeri SpA (Other)
Overall Status
Recruiting
CT.gov ID
NCT05758649
Collaborator
(none)
120
Enrollment
1
Location
46
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will assess cardiac and psychological profile at 2-3 months after recovery from COVID-19 infection.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A significant proportion of patients hospitalized for COVID-19 showed laboratory signs of myocardial damage, detected by elevated troponin levels, and these were associated with more severe clinical course and higher mortality. Moreover, it is unknown how the health emergency and the associated conditions may have influenced and still influence the psychological experience of the affected people.

    Thus, in order to promote continuity of care, post-COVID-19 disease clinics have therefore been activated dedicated to a specific follow-up program for monitoring long-term alterations and for the early identification of patients requiring rehabilitation.

    The program includes a first follow-up visit (2-3 months after recovery) including cardiac (2D-echocardiography, six-minute walking test, autonomic function evaluation) and psychological (Patient Health Questionnaire-9 (PHQ-9) Generalized Anxiety Disorder-7 (GAD) National Stressful Events Survey PTSD Short Scale (NSESSS)) evaluation.

    A second follow-up visit will be performed at 12 months in the form of structured interview,

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cardiovascular and Psychological Consequences of COVID-19
    Actual Study Start Date :
    Oct 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Jul 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. prevalence of patients with cardiovascular or psychological sequelae [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Recent discharge (≤ 3 months) from a COVID+ ward for SARS-CoV-2 disease
    Exclusion Criteria:

    • Serious clinical conditions (severe chronic inflammatory diseases, neoplasms, neurological pathologies).

    • Non-Italian education, illiteracy, or return to illiteracy.

    • Severe visual-perceptual deficits.

    • Low motivation/interest or refusal to undergo the assessment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ICS Maugeri Pavia Italy 27100

    Sponsors and Collaborators

    • Istituti Clinici Scientifici Maugeri SpA

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituti Clinici Scientifici Maugeri SpA
    ClinicalTrials.gov Identifier:
    NCT05758649
    Other Study ID Numbers:
    • CE 2450
    First Posted:
    Mar 7, 2023
    Last Update Posted:
    Mar 7, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 7, 2023