Cardiovascular Outcomes in Orthotopic Liver Transplanted Patients (COLT Study) (COLT)

June 6, 2023 updated by: Alfredo Caturano, University of Campania "Luigi Vanvitelli"

Evaluation of Cardiovascular Outcomes in Patients Undergoing Orthotopic Liver Transplantation: a Retrospective Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Napoli, Italy, 80138
        • Recruiting
        • University of Campania Luigi Vanvitelli
        • Contact:
        • Principal Investigator:
          • Teresa Salvatore, MD
    • SA
      • Gragnano, SA, Italy, 80054
        • Recruiting
        • Gragnano Hospital
        • Contact:
          • Carmine Coppola, MD
        • Principal Investigator:
          • Carmine Coppola, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patients with ortothopic liver transplantation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular death
Time Frame: 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)
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
cardiovascular complication
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Estimated)

May 2, 2024

Study Completion (Estimated)

May 2, 2024

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0012771/i

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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