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Completed

NCT Number: NCT02255123

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

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.

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Key information

Conditions

Cardiac Transplantation

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California at San Francisco, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects previously enrolled in the CTOT-05 study
  • Subjects 4 years post-transplant (+/- 6 months).

Exclusion criteria

  • Withdrawal of consent from the CTOT-05 study.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Incidence of death

    Time frame: 48 months (+/- 6 months) after primary transplantation

  2. Incidence of re-transplantation or re-listed for transplantation

    Time frame: 48 months (+/- 6 months) after primary transplantation

  3. Incidence of coronary stent

    Time frame: 48 months (+/- 6 months) after primary transplantation

  4. Incidence of myocardial infarction

    Time frame: 48 months (+/- 6 months) after primary transplantation

  5. 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)

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

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Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 2, 2014
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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