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Trial record 1 of 1 for:    CTOT-18
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Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02255123
First Posted: October 2, 2014
Last Update Posted: March 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
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.

Condition
Cardiac Transplantation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study (CTOT-18)

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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)



Secondary Outcome Measures:
  • Incidence of death [ Time Frame: 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 ]
  • Incidence of coronary stent [ Time Frame: 48 months (+/- 6 months) after primary transplantation ]
  • Incidence of myocardial infarction [ Time Frame: 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)



Enrollment: 178
Study Start Date: October 2014
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255123


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