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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02255123

Enrollment

178

Registered

2014-10-02

Start date

2014-10-31

Completion date

2015-06-30

Last updated

2016-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Transplantation

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 coronary stent	48 months (+/- 6 months) after primary transplantation	—
Incidence of myocardial infarction	48 months (+/- 6 months) after primary transplantation	—
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)

Countries

United States

Outcome results