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

Completed

• Conditions: Cardiac Transplantation

• Registration Number: NCT02255123
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-09-30
• Study Start: 2014-10
• Study First Posted: 2014-10-02
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite incidence of Death, Re-transplantation or re-listed for transplantation, Coronary stent, Myocardial Infarction and Clinical evidence of CAV per ISHLT grading	48 months (+/- 6 months) after primary transplantation	Coronary Artery Vasculopathy (CAV); International Society for Heart and Lung Transplantation Registry (ISHLT)

Secondary Outcome Measures

Name	Time	Method
Incidence of clinical evidence of CAV per ISHLT grading	48 months (+/- 6 months) after primary transplantation	Coronary Artery Vasculopathy (CAV); International Society for Heart and Lung Transplantation Registry (ISHLT)
Incidence of death	48 months (+/- 6 months) after primary transplantation
Incidence of re-transplantation or re-listed for transplantation	48 months (+/- 6 months) after primary transplantation
Incidence of myocardial infarction	48 months (+/- 6 months) after primary transplantation
Incidence of coronary stent	48 months (+/- 6 months) after primary transplantation

Trial Locations

Locations (12)

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Newark Beth Israel Medical Center; 🇺🇸 Newark, New Jersey, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Brigham & Womens Hospital; 🇺🇸 Boston, Massachusetts, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Loyola University Medical; 🇺🇸 Maywood, Illinois, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Medical City Dallas Hospital/ CRSTI; 🇺🇸 Dallas, Texas, United States