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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Arizona
-
Phoenix, Arizona, 미국, 85054
- Mayo Clinic
-
-
California
-
Beverly Hills, California, 미국, 90211
- Cedars-Sinai Medical Center
-
Los Angeles, California, 미국, 90095
- University of California, Los Angeles
-
Stanford, California, 미국, 94305
- Stanford University
-
-
Florida
-
Gainesville, Florida, 미국, 32610
- University of Florida,
-
Hollywood, Florida, 미국, 33021
- Memorial Regional Hospital
-
Tampa, Florida, 미국, 33606
- Tampa General Hospital
-
-
Georgia
-
Atlanta, Georgia, 미국, 30322
- Emory University
-
-
Illinois
-
Chicago, Illinois, 미국, 60611
- Northwestern University
-
Chicago, Illinois, 미국, 60637
- University of Chicago
-
-
Indiana
-
Indianapolis, Indiana, 미국, 46260
- St. Vincent Medical Group
-
-
Kentucky
-
Lexington, Kentucky, 미국, 40536
- University of Kentucky
-
Louisville, Kentucky, 미국, 40202
- University of Louisville
-
-
Louisiana
-
New Orleans, Louisiana, 미국, 70121
- Ochsner Clinic Foundation
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48109
- University of Michigan
-
-
Minnesota
-
Minneapolis, Minnesota, 미국, 55455
- University of Minnesota
-
-
Missouri
-
Kansas City, Missouri, 미국, 64111
- Mid America Heart Institute - St. Luke's Hospital
-
Saint Louis, Missouri, 미국, 63110
- Washington University
-
-
New York
-
New York, New York, 미국, 10032
- Columbia University Medical Center
-
New York, New York, 미국, 10029
- Mount Sinai Hospital
-
-
Ohio
-
Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Foundation
-
Columbus, Ohio, 미국, 43210
- Ohio State University
-
-
Oklahoma
-
Oklahoma City, Oklahoma, 미국, 73112
- Integris Baptist Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19140
- Temple University
-
Philadelphia, Pennsylvania, 미국, 19102
- Drexel University
-
Pittsburgh, Pennsylvania, 미국, 15212
- Allegheny General Hospital
-
Pittsburgh, Pennsylvania, 미국, 15219
- University of Pittsburgh Medical Center
-
-
Tennessee
-
Nashville, Tennessee, 미국, 37232
- Vanderbilt University Medical Center
-
-
Texas
-
Dallas, Texas, 미국, 75390
- UT Southwestern Medical Center
-
Dallas, Texas, 미국, 75246
- Baylor Research Institute
-
Houston, Texas, 미국, 77030
- Houston Methodist Research Institute
-
Houston, Texas, 미국, 77030
- Baylor St. Lukes
-
-
Utah
-
Murray, Utah, 미국, 84107
- Intermountain Heart Institute
-
-
Virginia
-
Falls Church, Virginia, 미국, 22042
- Inova Heart & Vascular Institute
-
Richmond, Virginia, 미국, 23298
- Virginia Commonwealth University
-
-
Wisconsin
-
Milwaukee, Wisconsin, 미국, 53215
- Aurora St. Luke's Medical Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
Heart transplant recipients
Heart transplant rejection surveillance including AlloMap testing
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Vital status of heart transplant recipient
기간: 5 Years
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Surveillance visit schedules and patient management parameters
기간: 5 Years
|
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
|
5 Years
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: James P Yee, MD, PhD, CareDx, Inc., Brisbane, CA
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
심장 질환에 대한 임상 시험
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University of... 그리고 다른 협력자들아직 모집하지 않음심부전, 수축기 | 박출률이 감소된 심부전 | 심부전 New York Heart Association Class IV | 심부전 New York Heart Association Class III폴란드
-
Novartis Pharmaceuticals완전한핵심 연구의 12개월 치료 기간을 성공적으로 완료한 환자(de Novo Heart Recipients)는 EC-MPS 치료에 관심이 있었습니다.
-
University of WashingtonAmerican Heart Association완전한심부전，울혈 | 미토콘드리아 변경 | 심부전 New York Heart Association Class IV미국
-
University of Pennsylvania완전한Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410의 주진단 또는 이차진단 코드가 있는 환자(5번째 숫자가 2인 경우 제외)미국