NCT02255123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

8 months

First QC Date

September 30, 2014

Last Update Submit

March 22, 2016

Conditions

Cardiac Transplantation

Outcome Measures

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

    Coronary Artery Vasculopathy (CAV) International Society for Heart and Lung Transplantation Registry (ISHLT)

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

Secondary Outcomes (5)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Loyola University Medical

Maywood, Illinois, 60153, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Womens Hospital

Boston, Massachusetts, 02115, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Medical City Dallas Hospital/ CRSTI

Dallas, Texas, 75230, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related 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.

    PMID: 26260101BACKGROUND

Related Links

Study Officials

  • Peter S Heeger, M.D.

    Icahn School of Medicine at Mount Sinai

    STUDY CHAIR

  • Anil K. Chandraker, M.D.

    Brigham and Women's Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 2, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 23, 2016

Record last verified: 2016-03

Locations

US(12)