Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety of radiosurgery of ganglion stellatum
研究概览
简要总结
The core hypothesis to be tested is that the radiosurgery of stellate ganglion (left one or both if left-sided without full relief of symptoms) is an effective therapy of refractory angina pectoris in patients with no other therapeutic options - proof of concept study.
详细描述
Design: prospective, interventional trial (University Hospital Ostrava, Cardiocentre AGEL Podlesi Hospital Trinec)
- radiosurgery of left GS after confirmation of responding to anesthetic blockade
- in case of remaining AP after three months, radiosurgery of right GS in case of response confirmation to anesthetic blockade (patients must be responders of anesthetic blockade of left stellate ganglion)
- Seattle Angina Questionary (SAQ) and amount of nitrate usage for responding confirmation
- Radiotherapy 40 Gy
- 2-year follow-up
- Scheduled follow-up visits: 1, 3, 6, 12, and 24 months (24)
Preliminary examination: selective coronary angiography, transthoracic echocardiography, stress test, 6 min walk test, SAQ (19-item)
Endopoints:
Primary Endpoints: SAQ, safety of the radiosurgery of GS Secondary Endpoints:usage decrease of angina relief drugs, 6 min walk test improvement
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must have coronary artery disease (CAD) with refractory angina pectoris (AP).
- •Patients must have a maximum of tolerated medication therapy of angina pectoris available.
- •Patients must have done the maximum possible revascularization of CAD.
- •Two certificated independent interventional cardiologists and two cardiac surgeons must conclude that further revascularization (including CABG) is not possible/not effective/ with high risk.
- •Age ≥ 18 years.
- •Patients must have any stress test with proof of myocardial ischemia (dobutamine echocardiography, gated Tc-SPECT of myocardium).
- •Life expectancy at least 24 months (not limited due to severe comorbidities)
- •Patients must be responders of anesthetic blockade of the left stellate ganglion (GS) - clinically significant relief of AP symptoms after blockade at least twice.
- •Patients must provide verbal and written informed consent to participate in the study.
排除标准
- •Life expectancy less than 24 months
- •Non-responders of anesthetic blockade of GS
- •Impossibility to undergo a stress test.
- •Myocardial infarction in last 4 weeks
- •Heart failure - class IV NYHA
- •Unwillingness to participate or inability to comply with the protocol for the duration of the study
- •Patients who are pregnant, and patients with reproductive capability will need to use adequate contraception during the time of participation in the study
- •History of radiotherapy in the head and neck region
研究组 & 干预措施
Radiosurgery of Ganglion Stellatum
Patients will undergo radiosurgery of the ganglion stellatum (left one or both)
干预措施: Radiosurgery of ganglion stellatum (Procedure)
结局指标
主要结局
Safety of radiosurgery of ganglion stellatum
时间窗: 24 months
Safety of radiosurgery of ganglion stellatum will be observed and assessed according to the occurrence of adverse events
Seattle Angina Questionnaire
时间窗: 24 months
The Seattle Angina Questionnaire is a cardiac disease-related quality-of-life measure with 19 items. A lower score corresponds to a lower level of functioning. The scores are classified as "minimal (scores 75-100), mild (50-74), moderate (25-49), and severe (0-24).
次要结局
- Usage of angina pectoris relief drugs(24 months)
- Six-minute walk test improvement(24 months)