Remote Ischemic Conditioning for Protection From Treatment-related Cardiotoxicity in Pediatric, Adolescent, and Young Adult Patients Undergoing Anthracycline Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Adverse Effects
研究概览
简要总结
This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. Patients undergoing anthracycline chemotherapy for Hodgkin disease and soft-tissue and bone sarcoma who meet eligibility requirements will be approached to participate in the study. The purpose of the study is to determine if performing remote ischemic conditioning (RIC) is feasible in children and young adults receiving anthracycline chemotherapy. The secondary purpose is to describe differences in markers of myocardial injury and stress in children and young adults that receive RIC prior to anthracycline chemotherapy compared to control subjects that receive sham therapy prior to chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric, adolescent, or young adult patients, 11 years of age or above.
- •Able to tolerate upper arm blood pressure inflation.
排除标准
- •Previous diagnosis of cardiomyopathy (dilated, hypertrophic, restrictive, myocarditis) or congenital heart disease other than bicuspid aortic valve.
- •Chronic kidney disease as defined as a pre-transplant GFR <80
- •Central line in both upper extremities.
- •Known peripheral vascular disease or vasculitis.
- •Platelet count less than 30,
- •Known clotting disorder or hypercoagulability
- •Non-English-speaking patients.
结局指标
主要结局
Adverse Effects
时间窗: 18-24 months from start of enrollment
Patients with intra-thoracic disease may also receive consolidative radiation that includes portions of the myocardium within the radiation field and thus further increase their risk of developing therapy-related cardiomyopathy. Thus, the development of cardioprotective strategies during therapy for these malignancies is of primary interest to minimize the potential late adverse effects of anthracyclines among the long term survivors of these conditions.
次要结局
未报告次要终点