Clinical trial NCT02255123: Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study
Official title: A Retrospective Multicenter Study to Determine 4-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-05 Study (CTOT-18)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Transplantation
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2014-10-02
Enrollment: 178
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Composite incidence of Death, Re-transplantation or re-listed for transplantation, Coronary stent, Myocardial Infarction and Clinical evidence of CAV per ISHLT grading
timeFrame: 48 months (+/- 6 months) after primary transplantation
Secondary outcomes:
measure: Incidence of death
timeFrame: 48 months (+/- 6 months) after primary transplantation
measure: Incidence of re-transplantation or re-listed for transplantation
timeFrame: 48 months (+/- 6 months) after primary transplantation
measure: Incidence of coronary stent
timeFrame: 48 months (+/- 6 months) after primary transplantation
measure: Incidence of myocardial infarction
timeFrame: 48 months (+/- 6 months) after primary transplantation
measure: Incidence of clinical evidence of CAV per ISHLT grading
timeFrame: 48 months (+/- 6 months) after primary transplantation
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Womens Hospital
state: Massachusetts
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dallas
country: United States
facility: Medical City Dallas Hospital/ CRSTI
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Peter S Heeger, M.D.
role: STUDY_CHAIR
affiliation: Brigham and Women's Hospital
name: Anil K. Chandraker, M.D.
role: STUDY_CHAIR
References:
citation: Starling RC, Stehlik J, Baran DA, Armstrong B, Stone JR, Ikle D, Morrison Y, Bridges ND, Putheti P, Strom TB, Bhasin M, Guleria I, Chandraker A, Sayegh M, Daly KP, Briscoe DM, Heeger PS; CTOT-05 consortium. Multicenter Analysis of Immune Biomarkers and Heart Transplant Outcomes: Results of the Clinical Trials in Organ Transplantation-05 Study. Am J Transplant. 2016 Jan;16(1):121-36. doi: 10.1111/ajt.13422. Epub 2015 Aug 10.