Extracellular Vesicles for Rejection Monitoring in Cardiac Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Identification of an extracellular vesicle-derived biomarker or biomarker pattern to diagnose endomyocardial biopsy-proven acute cellular or antibody-mediated cardiac allograft rejection
研究概览
简要总结
This study will analyze extracellular vesicle (EV)-derived protein profiles in heart transplantated patients during the first 15 months post-transplantation to investigate, if there are distinct EV-derived proteins or protein patterns that allow early and reliable diagnosis of acute cardiac allograft rejection. Additionally, it will explore temporal changes in the EV-derived protein profile during the early postoperative period irrespective of acute allograft rejection, and will investigate, if there are correlations between EV protein markers and imaging findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is either on the heart transplant waiting list or is still hospitalised following HTx surgery.
- •Age of subject is ≥ 18 years.
- •Subject is female or male.
- •Capacity to consent.
- •Signed written informed consent.
- •For female subjects:
- •Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or
- •If being of childbearing potential: Negative highly sensitive urine or serum pregnancy test before inclusion.
排除标准
- •Concurrent multiple solid organ or tissue transplants.
- •Prior history of any organ or cellular transplantation.
- •Subject suffers from an addiction or from a disease that prevents the subject from recognising nature, scope, and consequences of the study.
- •Subject shows an inability to comply with all the study procedures and follow-up visits.
- •Subject is legally detained in an official institution.
- •Subjects who are unwilling to consent to saving and propagation of pseudonymised medical data for study reasons.
- •Subject is financially dependent on the investigators or the study site.
结局指标
主要结局
Identification of an extracellular vesicle-derived biomarker or biomarker pattern to diagnose endomyocardial biopsy-proven acute cellular or antibody-mediated cardiac allograft rejection
时间窗: From entrollment to the end of study participation at 15 months
Change of the level of at least one EV-derived biomarker in the blood plasma of cardiac allograft recipients with endomyocardial biopsy-proven acute cellular or antibody-mediated cardiac allograft rejection compared to those with no rejection at the time of blood sampling.
次要结局
未报告次要终点
研究者
Laurenz Kopp Fernandes
Dr.
Charite University, Berlin, Germany