Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients
Observational Study of Alloimmunity in Cardiac Transplant Recipients
Injury of transplant tissue by a transplant recipient's immune system continues to be the leading cause of graft rejection and recipient death. The purpose of this study is to identify a single test or a combination of noninvasive tests currently used for heart transplant monitoring that correlate to long-term graft survival.
研究概览
详细说明
A major cause of heart transplant failure is the blockage of blood flow from lesions caused by ongoing injury and repair of the graft by the host's immune system. However, the role of T cells, antibodies, and other parts of the recipient's immune system are not well understood in transplant injury. Currently, there are no effective, noninvasive ways to detect or predict how an individual's immune system will react to a transplant. The purpose of this study is to correlate current noninvasive monitoring tests with long-term graft survival and function, and determine which tests are the most accurate predictors of this survival.
Participants in this study must currently be on the waiting list for a heart transplant and have a donor heart available to them. This study will consist of six study visits over 12 months. The baseline visit will occur on the day of transplantation. Follow-up visits will occur at Week 6 and Months 3, 6, 9, and 12 post-transplant. At each visit, a physical exam, medication tracking, assessment of graft survival, and blood and urine collection will occur. At the Week 6 and Month 12 visits, intravascular ultrasound and echocardiograms will occur. At the Week 6, Month 6, and Month 12 visits, endomyocardial biopsies will also occur. No immunosuppressive therapy will be provided by the study.
研究类型
注册 (实际的)
联系人和位置
学习地点
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California
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San Francisco、California、美国、94143
- University of California
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University Medical School
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Maywood、Illinois、美国、60153
- Loyola University School of Medicine
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Maryland
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Baltimore、Maryland、美国、21201
- University of Maryland
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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New Jersey
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Newark、New Jersey、美国、07112
- Beth Israel Medical Center
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New York
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New York、New York、美国、10029
- Mount Sinai School of Medicine
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Ohio
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Cleveland、Ohio、美国、44122
- The Cleveland Clinic Foundation
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Texas
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Dallas、Texas、美国、75230
- Medical City Dallas Hospital
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Utah
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Salt Lake City、Utah、美国、84148
- University of Utah, LDS Hospital
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Salt Lake City、Utah、美国、84148
- University of Utah, VACM.LDS
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
People who are on the waiting list for a heart transplant at one of the participating study sites (listed below)
描述
Inclusion Criteria:
- Age greater than 10 and a body mass of 30 kg (66 lbs) or more
- On waiting list for a heart transplant for whom a donor heart available
- Willing to comply with study protocol
- Willing to use acceptable forms of contraception
- Parent or guardian willing to provide consent, if applicable
Exclusion Criteria:
- Receiving multiple organ transplants
- Previously received organ transplants
- Other comorbidities that, in the opinion of the site investigator, would interfere with the study
- Currently taking immunosuppression for nontransplant reasons
- Participation in an interventional clinical trial
- Pregnancy or breastfeeding
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_ONLY
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Heart Transplant Recipients
People who will have a heart transplant |
People in this study will have a heart transplant and be monitored for signs of rejection |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Composite Measure of Transplant Health
大体时间：12 months after enrollment in study
|
A composite of incidence of the following:
|
12 months after enrollment in study
|
合作者和调查者
调查人员
- 首席研究员：Mohamed H. Sayegh, MD、Brigham and Women's Hospital
- 首席研究员：Peter S. Heeger, MD、Icahn School of Medicine at Mount Sinai
- 学习椅：Randall Starling, MD、The Cleveland Clinic
出版物和有用的链接
一般刊物
- Jiang S, Lechler RI. CD4+CD25+ regulatory T-cell therapy for allergy, autoimmune disease and transplant rejection. Inflamm Allergy Drug Targets. 2006 Dec;5(4):239-42. doi: 10.2174/187152806779010981.
- Zheng XX, Sanchez-Fueyo A, Sho M, Domenig C, Sayegh MH, Strom TB. Favorably tipping the balance between cytopathic and regulatory T cells to create transplantation tolerance. Immunity. 2003 Oct;19(4):503-14. doi: 10.1016/s1074-7613(03)00259-0.
- 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.
- Starling RC, Pham M, Valantine H, Miller L, Eisen H, Rodriguez ER, Taylor DO, Yamani MH, Kobashigawa J, McCurry K, Marboe C, Mehra MR, Zuckerman A, Deng MC; Working Group on Molecular Testing in Cardiac Transplantation. Molecular testing in the management of cardiac transplant recipients: initial clinical experience. J Heart Lung Transplant. 2006 Dec;25(12):1389-95. doi: 10.1016/j.healun.2006.10.002. No abstract available.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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