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Cardiac TransplantationNCT02255123

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

An observational study of Cardiac Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cardiac Transplantation
How many people
178 participants
Where
12 sitesUnited States
Study dates
Oct 2014to Jun 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 1. Withdrawal of consent from the CTOT-05 study.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • University of Maryland

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham & Womens Hospital

    Boston, Massachusetts, 02115

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Medical City Dallas Hospital/ CRSTI

    Dallas, Texas, 75230

  • Loyola University Medical

    Maywood, Illinois, 60153

  • Intermountain Medical Center

    Murray, Utah, 84157

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of California at San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

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

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

Secondary outcomes (5)

  1. Incidence of death

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

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

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

  3. Incidence of coronary stent

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

  4. Incidence of myocardial infarction

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

  5. Incidence of clinical evidence of CAV per ISHLT grading

    Coronary Artery Vasculopathy (CAV)

    International Society for Heart and Lung Transplantation Registry (ISHLT)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02255123
Sponsor's protocol ID
DAIT CTOT-18
Status last verified
Sep 2026
First submitted
30 Sep 2014
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26260101

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02255123, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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