- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01833195
Outcomes AlloMap Registry: the Long-term Management and Outcomes of Heart Transplant Recipients With AlloMap Testing (OAR)
Outcomes AlloMap Registry Study: the Clinical Long-term Management and Outcomes of Heart Transplant Recipients With Regular Rejection Surveillance Including Use of AlloMap Gene-expression Profiling Testing
Przegląd badań
Status
Szczegółowy opis
The standard of care in adult heart transplant recipients has been to perform periodic endomyocardial biopsies for surveillance for rejection. Because of the risks and discomforts associated with the biopsy procedure, a non-invasive test (AlloMap) based on gene-expression profiling of peripheral blood was developed and introduced in 2005 to identify heart transplant recipients who have a low probability of rejection at the time of protocol surveillance testing. The schedule of AlloMap surveillance testing has been derived from the customary timing of surveillance biopsies: e.g. at 1 to 2 month intervals for patients who are 6 and 12 post-transplantation, and at 3, 4 or 6 months after the first year post-transplantation.
In the large multicenter IMAGE (Invasive Monitoring Attenuation by Gene Expression Profiling) 602 patients in the United States who had undergone cardiac transplantation at least 6 months prior were randomized 1:1 to either surveillance with routine biopsy or AlloMap testing. Patients in both groups were also monitored with echocardiography. A primary outcome event was defined as an episode of rejection with hemodynamic compromise, graft dysfunction due to other causes, death or retransplantation. Over a median follow-up period of 19 months, 297 patients who were monitored with AlloMap and 305 patients who underwent routine biopsies had similar 2-year cumulative rates of events (14.5% and 15.3%, respectively; hazard ratio with gene-expression profiling, 1.04; 95% confidence interval, 0.67 to 1.68).
This Outcomes AlloMap Registry (OAR) study is designed to collect similar clinical outcomes information as studied in IMAGE, in a larger cohort of patients (approximately 2000) followed for up to 5 years. At each routine clinic visit, key clinical features such as rejection surveillance management schedules, testing results (e.g. blood levels of immunosuppressive agents), and AlloMap scores will be collected. This larger and longer term follow-up dataset is intended to enable further elucidation, through analyses techniques such as multivariate Cox proportional hazards models, of the surveillance management features which may be associated or contribute to the most favorable long term outcomes of the heart recipients.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Arizona
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Phoenix, Arizona, Stany Zjednoczone, 85054
- Mayo Clinic
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California
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Beverly Hills, California, Stany Zjednoczone, 90211
- Cedars-Sinai Medical Center
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Los Angeles, California, Stany Zjednoczone, 90095
- University of California, Los Angeles
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Stanford, California, Stany Zjednoczone, 94305
- Stanford University
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Florida
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Gainesville, Florida, Stany Zjednoczone, 32610
- University of Florida,
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Hollywood, Florida, Stany Zjednoczone, 33021
- Memorial Regional Hospital
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Tampa, Florida, Stany Zjednoczone, 33606
- Tampa General Hospital
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30322
- Emory University
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60611
- Northwestern University
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Chicago, Illinois, Stany Zjednoczone, 60637
- University of Chicago
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Indiana
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Indianapolis, Indiana, Stany Zjednoczone, 46260
- St. Vincent Medical Group
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Kentucky
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Lexington, Kentucky, Stany Zjednoczone, 40536
- University of Kentucky
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Louisville, Kentucky, Stany Zjednoczone, 40202
- University of Louisville
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Louisiana
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New Orleans, Louisiana, Stany Zjednoczone, 70121
- Ochsner Clinic Foundation
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48109
- University of Michigan
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Minnesota
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Minneapolis, Minnesota, Stany Zjednoczone, 55455
- University of Minnesota
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Missouri
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Kansas City, Missouri, Stany Zjednoczone, 64111
- Mid America Heart Institute - St. Luke's Hospital
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Saint Louis, Missouri, Stany Zjednoczone, 63110
- Washington University
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New York
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New York, New York, Stany Zjednoczone, 10032
- Columbia University Medical Center
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New York, New York, Stany Zjednoczone, 10029
- Mount Sinai Hospital
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Ohio
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Cleveland, Ohio, Stany Zjednoczone, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, Stany Zjednoczone, 43210
- Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Stany Zjednoczone, 73112
- Integris Baptist Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19140
- Temple University
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19102
- Drexel University
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15212
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15219
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, Stany Zjednoczone, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Stany Zjednoczone, 75390
- UT Southwestern Medical Center
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Dallas, Texas, Stany Zjednoczone, 75246
- Baylor Research Institute
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Houston, Texas, Stany Zjednoczone, 77030
- Houston Methodist Research Institute
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Houston, Texas, Stany Zjednoczone, 77030
- Baylor St. Lukes
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Utah
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Murray, Utah, Stany Zjednoczone, 84107
- Intermountain Heart Institute
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Virginia
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Falls Church, Virginia, Stany Zjednoczone, 22042
- Inova Heart & Vascular Institute
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Richmond, Virginia, Stany Zjednoczone, 23298
- Virginia Commonwealth University
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Wisconsin
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Milwaukee, Wisconsin, Stany Zjednoczone, 53215
- Aurora St. Luke's Medical Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- New and existing heart transplant recipients ≥ 2 months (≥ 55 days) post-transplant receiving post-transplant care at the enrolling centers for interim surveillance monitoring that includes AlloMap testing
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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Heart transplant recipients
Heart transplant rejection surveillance including AlloMap testing
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Vital status of heart transplant recipient
Ramy czasowe: 5 Years
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Hospitalizations and causes (i.e. infections or graft dysfunction (classified as: acute cellular rejection, antibody mediated rejection , cardiac allograft vasculopathy or non specific etiology of graft dysfunction Cancers (newly diagnosed and/or recurrent): onset and classification of types of cancers |
5 Years
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Surveillance visit schedules and patient management parameters
Ramy czasowe: 5 Years
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Endomyocardial biopsy and histology grades of rejection; left ventricular echocardiograms and ejection fractions; maintenance immunosuppressive drugs categories and doses/ blood levels; AlloMap scores and score patterns
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5 Years
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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: James P Yee, MD, PhD, CareDx, Inc., Brisbane, CA
Publikacje i pomocne linki
Publikacje ogólne
- Pham MX, Teuteberg JJ, Kfoury AG, Starling RC, Deng MC, Cappola TP, Kao A, Anderson AS, Cotts WG, Ewald GA, Baran DA, Bogaev RC, Elashoff B, Baron H, Yee J, Valantine HA; IMAGE Study Group. Gene-expression profiling for rejection surveillance after cardiac transplantation. N Engl J Med. 2010 May 20;362(20):1890-900. doi: 10.1056/NEJMoa0912965. Epub 2010 Apr 22.
- Shah MR, Starling RC, Schwartz Longacre L, Mehra MR; Working Group Participants. Heart transplantation research in the next decade--a goal to achieving evidence-based outcomes: National Heart, Lung, And Blood Institute Working Group. J Am Coll Cardiol. 2012 Apr 3;59(14):1263-9. doi: 10.1016/j.jacc.2011.11.050.
- Kanwar, M. et al: Correlation of Longitudinal Gene-Expression Profiling Score to Cytomegalovirus (CMV) Infection: Results from the Outcomes AlloMap Registry (OAR). ISHLT 35th Annual Meeting and Scientific Sessions. 2015 April 13-18, 2015; Nice, France. *2015 American Transplant Congress. May 2-6, 2015; Philadelphia, PA. Poster.
- Teuteberg, J. et al; Gene-Expression Profiling to Monitor for Rejection-Which Patients are Being Offered This Strategy? ISHLT 35th Annual Meeting and Scientific Sessions. 2015 April 13-18, 2015; Nice, France. 2015. *American Transplant Congress. May 2-6, 2015; Philadelphia, PA. Poster.
- Sulemanjee, N. et al; Gender-Mismatched Heart Transplants and Gene Expression Profiling Score-Lessons Learned from the Outcomes AlloMap Registry (OAR). ISHLT 35th Annual Meeting and Scientific Sessions. 2015 April 13-18, 2015; Nice, France. 2015 *American Transplant Congress. May 2-6, 2015; Philadelphia, PA. Poster.
- Kanwar, M. et al; Impact of Cytomegalovirus Infection on Longitudinal Gene-Expression Profiling Score: Results from the Outcomes AlloMap Registry. 2016 ISHLT 36th Annual Meeting and Scientific Sessions. April 27-30, 2016; Washington, DC.
- Teuteberg, JJ. et al; Higher Rate of Hospitalizations for Infection and Cancer Then Rejection in Low Risk Heart Transplant Patients Followed by Gene Expression Profiling. 2016 ISHLT 36th Annual Meeting and Scientific Sessions. April 27-30, 2016; Washington, DC.
- Teuteberg, JJ. et al; Gene Expression Profiling Score and the Risk of Infection in Heart Transplant. 2016 American Transplant Congress. June 12, 2016; Boston, MA Poster
- Teuteberg, J., Shullo, MA., Rinde-Hoffman, D., Wigger, M., Wang, YS., Wolf, T., Arnold, PJ., Sninsky, J., Berman, P. Routine Surveillance of Heart Transplant Recipients with Gene Expression Profiling: Lack of an Impact of Race on Outcomes. 2017 American Transplant Congress. April 29-May 3, 2017; Chicago, IL. Poster
- Shah, P. et al: Outcomes with Gene Expression Profiling for Cardiac Transplant Recipients Within North America. 2016 ISHLT 36th Annual Meeting and Scientific Sessions. April 27-30, 2016; Washington, DC.
- Uriel, N. et al; Utility of Gene Expression (AlloMap Score) in Antibody Mediated Rejection Detection. 2016 ISHLT 36th Annual Meeting and Scientific Sessions. April 27-30, 2016; Washington, DC.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SN-C-00003
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