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Cardiovascular Outcomes in Orthotopic Liver Transplanted Patients (COLT Study)

Sponsor
University of Campania "Luigi Vanvitelli" (Other)
Overall Status
Recruiting
CT.gov ID
NCT05895669
Collaborator
(none)
100
Enrollment
2
Locations
12
Anticipated Duration (Months)
50
Patients Per Site
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

All patients with orthotopic liver transplantation who are evaluated and followed at each participating centers will be recorded in this study. Within this register a characterization of patients and therapy will be done. Prognostic factors of defined clinical relevant endpoints will be evaluated.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Evaluation of Cardiovascular Outcomes in Patients Undergoing Orthotopic Liver Transplantation: a Retrospective Cohort Study
    Actual Study Start Date :
    May 2, 2023
    Anticipated Primary Completion Date :
    May 2, 2024
    Anticipated Study Completion Date :
    May 2, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Cardiovascular death [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months]

      death due to cardiac causes (myocardial infraction and/or stroke)

    2. cardiovascular complication [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months]

      fatal and non fatal myocardial infraction and/or stroke

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • All patients with ortothopic liver transplantation and at least 2 year follow-up at the referral center
    Exclusion Criteria:

    • Missing Informed Consent Form

    • Missing Contact Informations for Follow up

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gragnano Hospital Gragnano SA Italy 80054
    2 University of Campania Luigi Vanvitelli Napoli Italy 80138

    Sponsors and Collaborators

    • University of Campania "Luigi Vanvitelli"

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alfredo Caturano, Principal Investigator, University of Campania "Luigi Vanvitelli"
    ClinicalTrials.gov Identifier:
    NCT05895669
    Other Study ID Numbers:
    • 0012771/i
    First Posted:
    Jun 8, 2023
    Last Update Posted:
    Jun 8, 2023
    Last Verified:
    Jun 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:
    Myocardial Infarction

    Study Results

    No Results Posted as of Jun 8, 2023