Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study

March 22, 2016 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study (CTOT-18)

This study is a multicenter, non-randomized, retrospective study to collect long term (4 years post-transplant) clinical outcome data on subjects previously enrolled in the CTOT-05 study (NCT00466804) to evaluate participant and graft survival.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

178

Contacts and Locations

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

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California at San Francisco
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Brigham & Womens Hospital
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Texas
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital/ CRSTI
    • Utah
      • Murray, Utah, United States, 84157
        • Intermountain Medical Center
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population was selected based on their previous participation in the parent study (CTOT-05). Participants enrolled in this study are at least 4 years post-transplant as of July 2014.

Description

Inclusion Criteria:

  1. Subjects previously enrolled in the CTOT-05 study
  2. Subjects 4 years post-transplant (+/- 6 months).

Exclusion Criteria:

1. Withdrawal of consent from the CTOT-05 study.

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
Composite incidence of Death, Re-transplantation or re-listed for transplantation, Coronary stent, Myocardial Infarction and Clinical evidence of CAV per ISHLT grading
Time Frame: 48 months (+/- 6 months) after primary transplantation

Coronary Artery Vasculopathy (CAV)

International Society for Heart and Lung Transplantation Registry (ISHLT)
48 months (+/- 6 months) after primary transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of death
Time Frame: 48 months (+/- 6 months) after primary transplantation
48 months (+/- 6 months) after primary transplantation
Incidence of re-transplantation or re-listed for transplantation
Time Frame: 48 months (+/- 6 months) after primary transplantation
48 months (+/- 6 months) after primary transplantation
Incidence of coronary stent
Time Frame: 48 months (+/- 6 months) after primary transplantation
48 months (+/- 6 months) after primary transplantation
Incidence of myocardial infarction
Time Frame: 48 months (+/- 6 months) after primary transplantation
48 months (+/- 6 months) after primary transplantation
Incidence of clinical evidence of CAV per ISHLT grading
Time Frame: 48 months (+/- 6 months) after primary transplantation

Coronary Artery Vasculopathy (CAV)

International Society for Heart and Lung Transplantation Registry (ISHLT)
48 months (+/- 6 months) after primary transplantation

Collaborators and Investigators

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Peter S Heeger, M.D., Icahn School of Medicine at Mount Sinai
  • Study Chair: Anil K. Chandraker, M.D., Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

October 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 30, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (Estimate)

October 2, 2014

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • DAIT CTOT-18

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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