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Active (not recruiting) NCT03695601

Surveillance HeartCare® Outcomes Registry

Conditions: Heart Transplant Rejection

Sponsor: CareDx

trial.available_in: БГ
Overview
This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.
Description
HeartCare is a service which includes AlloMap® and AlloSure-Heart® to provide information to help clinicians to more comprehensively monitor heart transplant recipients for allograft rejection. An approach to surveillance using HeartCare provides information from two complementary measures; AlloMap is a gene-expression profile based measure of host immune activity and risk of acute rejection. AlloSure-Heart monitors graft injury. AlloMap is the first FDA cleared test and is the only non-invasive, blood test method recommended in the International Society for Heart and Lung Transplantation (ISHLT) guidelines for surveillance of heart transplant recipients for rejection. AlloSure-Heart measures donor-derived cell-free DNA (dd-cfDNA) to help discriminate acute cellular rejection and antibody-mediated rejection from no rejection. Patients who receive HeartCare, as part of their post-transplant management, will give informed consent for information on their outcomes and other relevant clinical information, found in their medical records, to be entered into a SHORE database for purposes of the study.
Who can participate
Inclusion Criteria: 1. Patients who are 15 years of age or older at the time of blood draw. 2. Received a heart transplant (primary or repeat) 3. Patients who have HeartCare initiated within 3 months post-transplant Exclusion Criteria: 1\. Patients who are pregnant at the time of blood draw.
Interventions
Standard of Care
OTHER
Locations 67
United States (67)
Piedmont Heart Institute
Atlanta , Georgia
Ascension Seton
Austin , Texas
Tufts Medical Center
Boston , Massachusetts
Massachusetts General Hospital
Boston , Massachusetts
University of North Carolina at Chapel Hill
Chapel Hill , North Carolina
Medical University of South Carolina
Charleston , South Carolina
Northwestern University
Chicago , Illinois
University of Chicago Medicine
Chicago , Illinois
Cleveland Clinic
Cleveland , Ohio
The Ohio State University
Columbus , Ohio
Medical City Dallas
Dallas , Texas
Baylor Research Institute
Dallas , Texas
UT Southwestern Medical Center
Dallas , Texas
Henry Ford Health System
Detroit , Michigan
Inova Fairfax Medical Campus
Falls Church , Virginia
Stern Cardiovascular Foundation
Germantown , Tennessee
Spectrum Health
Grand Rapids , Michigan
Penn State Health Milton S. Hershey Medical Center
Hershey , Pennsylvania
Memorial Healthcare System
Hollywood , Florida
Baylor St. Luke's Medical Center
Houston , Texas
Houston Methodist Research Institute
Houston , Texas
UTHealth/ Memorial Hermann Hospital
Houston , Texas
Indiana University School of Medicine
Indianapolis , Indiana
Ascension St. Vincent Hospital and Health Care Center
Indianapolis , Indiana
Mayo Clinic- Florida
Jacksonville , Florida
The University of Kansas Medical Center
Kansas City , Kansas
St. Luke's Hospital of Kansas City
Kansas City , Missouri
University of California San Diego
La Jolla , California
Baptist Health Arkansas
Little Rock , Arkansas
Cedars-Sinai Medical Center
Los Angeles , California
University of California, Los Angeles
Los Angeles , California
University of Southern California
Los Angeles , California
University of Wisconsin School of Medicine and Public Health
Madison , Wisconsin
Northwell Health/ North Shore University Hospital
Manhassett , New York
Loyola University Medical Center
Maywood , Illinois
University of Miami
Miami , Florida
Medical College of Wisconsin
Milwaukee , Wisconsin
Aurora Research Institute
Milwaukee , Wisconsin
Intermountain Heart Institute
Murray , Utah
Saint Thomas Health
Nashville , Tennessee
Yale New Haven
New Haven , Connecticut
Ochsner Clinic Foundation
New Orleans , Louisiana
NYU Langone Health
New York , New York
Icahn School of Medicine at Mount Sinai
New York , New York
Columbia University Irving Medical Center
New York , New York
Sentara Cardiovascular Research Institute
Norfolk , Virginia
Advocate Christ Medical Center
Oak Lawn , Illinois
Integris Baptist Medical Center
Oklahoma City , Oklahoma
University of Nebraska Medical Center
Omaha , Nebraska
Advent Health
Orlando , Florida
University of Pennsylvania
Philadelphia , Pennsylvania
Mayo Clinic Arizona
Phoenix , Arizona
Allegheny-Singer Research Institute
Pittsburgh , Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh , Pennsylvania
Oregon Health and Science University
Portland , Oregon
Mayo Clinic Rochester
Rochester , Minnesota
University of Rochester Medical Center
Rochester , New York
Methodist Healthcare Systems of San Antonio
San Antonio , Texas
California Pacific Medical Center
San Francisco , California
University of California San Fransisco Medical Center
San Francisco , California
University of Washington
Seattle , Washington
Barnes Jewish Hospital, Washington University
St Louis , Missouri
Stanford University
Stanford , California
Tampa General Hospital
Tampa , Florida
Montefiore Medical Center
The Bronx , New York
Medstar Washington Hospital Center
Washington D.C. , District of Columbia
Wake Forest Medical Center
Winston-Salem , North Carolina
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
15 Years
Healthy volunteers
No
Start date
28.12.2018
Completion date
01.11.2026
Registry ID
NCT03695601
Source
clinicaltrials.gov
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