Surveillance HeartCare® Outcomes Registry
赞助:
CareDx
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | December 2018 | ||
| 预计主要完成日期 | December 2024 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Percentage of patients alive at one, two and three years post-transplantation.[ Time Frame: Dec-2024 ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Surveillance HeartCare® Outcomes Registry | ||
| 正式标题 ICMJE | Surveillance HeartCare® Outcomes Registry | ||
| 简要概况 | 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. |
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| 详细说明 | 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. | ||
| 研究类型 ICMJE | Observational | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
1600 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | June 2027 | ||
| 预计主要完成日期 | December 2024 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Patients who are 15 years of age or older at the time of blood draw. 2. Heart transplant recipients who are selected by their health care provider to be managed with HeartCare. 3. Patients who are selected by their health care provider to be managed following the Heart Routine Testing Schedule (HARTS) or a derivative of the schedule that has been defined by the provider. 4. Patients who provide written informed consent. 5. Patients who have HeartCare initiated within 30 days of signing the informed consent form. Exclusion Criteria: 1. Patients who are less than 15 years of age at the time of blood draw. 2. Heart transplant recipients who are not managed with HeartCare. 3. Patients who are not managed following the Heart Routine Testing Schedule (HARTS) or a derivative of the schedule that has been defined by the provider. 4. Patients who are pregnant at the time of blood draw. 5. Patients who do not provide written informed consent. | ||
| 性别 |
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| 年龄 | 最小年龄：15 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | CareDx | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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