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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Arizona
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Phoenix、Arizona、アメリカ、85054
- Mayo Clinic
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California
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Beverly Hills、California、アメリカ、90211
- Cedars-Sinai Medical Center
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Los Angeles、California、アメリカ、90095
- University of California, Los Angeles
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Stanford、California、アメリカ、94305
- Stanford University
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Florida
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Gainesville、Florida、アメリカ、32610
- University of Florida,
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Hollywood、Florida、アメリカ、33021
- Memorial Regional Hospital
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Tampa、Florida、アメリカ、33606
- Tampa General Hospital
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University
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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern University
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Chicago、Illinois、アメリカ、60637
- University of Chicago
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Indiana
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Indianapolis、Indiana、アメリカ、46260
- St. Vincent Medical Group
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Kentucky
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Lexington、Kentucky、アメリカ、40536
- University of Kentucky
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Louisville、Kentucky、アメリカ、40202
- University of Louisville
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Louisiana
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New Orleans、Louisiana、アメリカ、70121
- Ochsner Clinic Foundation
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota
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Missouri
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Kansas City、Missouri、アメリカ、64111
- Mid America Heart Institute - St. Luke's Hospital
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Saint Louis、Missouri、アメリカ、63110
- Washington University
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New York
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New York、New York、アメリカ、10032
- Columbia University Medical Center
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New York、New York、アメリカ、10029
- Mount Sinai Hospital
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Foundation
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Columbus、Ohio、アメリカ、43210
- Ohio State University
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73112
- Integris Baptist Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19140
- Temple University
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Philadelphia、Pennsylvania、アメリカ、19102
- Drexel University
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Pittsburgh、Pennsylvania、アメリカ、15212
- Allegheny General Hospital
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Pittsburgh、Pennsylvania、アメリカ、15219
- University of Pittsburgh Medical Center
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Tennessee
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Nashville、Tennessee、アメリカ、37232
- Vanderbilt University Medical Center
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Texas
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Dallas、Texas、アメリカ、75390
- UT Southwestern Medical Center
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Dallas、Texas、アメリカ、75246
- Baylor Research Institute
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Houston、Texas、アメリカ、77030
- Houston Methodist Research Institute
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Houston、Texas、アメリカ、77030
- Baylor St. Lukes
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Utah
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Murray、Utah、アメリカ、84107
- Intermountain Heart Institute
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Virginia
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Falls Church、Virginia、アメリカ、22042
- Inova Heart & Vascular Institute
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Richmond、Virginia、アメリカ、23298
- Virginia Commonwealth University
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53215
- Aurora St. Luke's Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Heart transplant recipients
Heart transplant rejection surveillance including AlloMap testing
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Vital status of heart transplant recipient
時間枠：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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Surveillance visit schedules and patient management parameters
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディディレクター：James P Yee, MD, PhD、CareDx, Inc., Brisbane, CA
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
心臓疾患の臨床試験
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Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)