AlloSure Test Characteristics in Immunologically Quiescent and Immunologically Active Heart Transplant Recipients: Does Maximal Cardiopulmonary Stress Testing Prior to Assay Preserve Test Specificity While Enhancing Sensitivity?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- • Comparison of level of cell-free DNA
研究概览
简要总结
- Cell-free DNA does not vary significantly as a function of the activity of immunologically quiescent cardiac transplant recipients, despite the metabolic demands of the transplanted organ. (The implication of the null result would be that no restrictions to patient activity, nor modification of cardiac rehabilitation prescription, would be necessary to maintain proper test characteristics of AlloSure testing).
- In immunologically active cardiac transplant allografts, exercise prior to assay of donor-derived cell-free DNA can be used to increase the sensitivity of the AlloSure test. (The implication of this would be that the optimal time-frame for drawing an Allosure may actually be post-exercise, and that window will be characterized).
详细描述
The specific research questioned aimed to be addressed with this proposed study are:
i. Are dd-cfDNA levels in heart transplant recipients independent of recent cardiopulmonary exercise? More specifically, does the metabolic demand of maximal cardiopulmonary exercise in recent heart transplant recipients trigger a release of dd-cfDNA (if so, then what is the time course for resolution back to baseline?) ii. If dd-cfDNA does not release to any significant degree with cardiac allografts with short donor-ischemic time, does this test characteristic continue to hold for cardiac allografts transplanted after longer donor ischemic times? iii. In cardiac transplant recipients with medically stabilized, treated antibody-mediated rejection (AMR) and persistent dd-cfDNA elevation, does a discrete episode of maximal cardiometabolic activity trigger any additional elevation of dd-cfDNA, and again, with what time course?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Post-orthotopic heart transplant patients
排除标准
- •orthopedic, neurologic and/or any other limitations that do not allow for exercise testing on a treadmill or cycle ergometer;
- •individuals who require supplemental oxygen or have current permanent tracheostomies will be excluded from this study;
- •individuals who are discharged to a long-term acute care facility;
- •skilled nursing facility or with palliative care or hospice care will be excluded; (e) inmates and pregnant women;
- •(f) patients with antibody-mediate rejection that are not felt to be safe for cardiopulmonary stress testing.
结局指标
主要结局
• Comparison of level of cell-free DNA
时间窗: 10 days
Comparison of level of cell-free DNA
• Comparison of maximal oxygen consumption (VO2)
时间窗: 10 days
• Comparison of maximal oxygen consumption (VO2)
• Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise
时间窗: 10 days
• Cell-free DNA (AlloSure) levels after maximal cardiopulmonary exercise
次要结局
- • Time-dependent changes in high-sensitivity troponin-levels(10 days)