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NCT02255123 Clinical Trial

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

Cardiac Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02255123
Other study ID # DAIT CTOT-18
Secondary ID
Status Completed
Phase N/A
First received September 30, 2014
Last updated March 22, 2016
Start date October 2014
Est. completion date June 2015

Study information
Verified date March 2016
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 178
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Maryland Baltimore Maryland
United States Brigham & Womens Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Northwestern University Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States Medical City Dallas Hospital/ CRSTI Dallas Texas
United States Loyola University Medical Maywood Illinois
United States Intermountain Medical Center Murray Utah
United States Mount Sinai School of Medicine New York New York
United States Newark Beth Israel Medical Center Newark New Jersey
United States University of Utah Salt Lake City Utah
United States University of California at San Francisco San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Composite incidence of Death, Re-transplantation or re-listed for transplantation, Coronary stent, Myocardial Infarction and Clinical evidence of CAV per ISHLT grading Coronary Artery Vasculopathy (CAV)
International Society for Heart and Lung Transplantation Registry (ISHLT)		 48 months (+/- 6 months) after primary transplantation No
Secondary Incidence of death 48 months (+/- 6 months) after primary transplantation No
Secondary Incidence of re-transplantation or re-listed for transplantation 48 months (+/- 6 months) after primary transplantation Yes
Secondary Incidence of coronary stent 48 months (+/- 6 months) after primary transplantation No
Secondary Incidence of myocardial infarction 48 months (+/- 6 months) after primary transplantation No
Secondary Incidence of clinical evidence of CAV per ISHLT grading Coronary Artery Vasculopathy (CAV)
International Society for Heart and Lung Transplantation Registry (ISHLT)		 48 months (+/- 6 months) after primary transplantation No
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Active, not recruiting NCT00799188 - CERTICOEUR: A Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. Everolimus Versus Calcineurin Inhibitors Multicenter Trial Phase 3
Terminated NCT00284531 - Use of Daclizumab for the Prevention of Allograft Rejection in Pediatric Heart Transplant Patients Phase 1/Phase 2
Active, not recruiting NCT05904678 - Anatomical and Functional Assessment of Ex-vivo Coronary Perfusion
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Terminated NCT00166153 - Outcomes in Pediatric Heart Transplant Recipients Receiving Cellcept N/A
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