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

NCT ID: NCT02255123

Last Updated: 2016-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

178 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Cardiac Transplantation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter S Heeger, M.D.

Role: STUDY_CHAIR

Icahn School of Medicine at Mount Sinai

Anil K. Chandraker, M.D.

Role: STUDY_CHAIR

Brigham and Women's Hospital

Locations

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University of California at San Francisco

San Francisco, California, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Loyola University Medical

Maywood, Illinois, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Brigham & Womens Hospital

Boston, Massachusetts, United States

Site Status

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Medical City Dallas Hospital/ CRSTI

Dallas, Texas, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26260101 (View on PubMed)

Related Links

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http://www.niaid.nih.gov

The National Institute of Allergy and Infectious Diseases (NIAID)

https://www.ctotstudies.org/

Clinical Trials in Organ Transplantation (CTOT)

Other Identifiers

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DAIT CTOT-18

Identifier Type: -

Identifier Source: org_study_id

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