Screening for Coronary Artery Disease After Mediastinal Irradiation in Hodgkin Lymphoma Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- accurately identifying asymptomatic coronary artery disease
研究概览
简要总结
Survivors of Hodgkin Lymphoma (HL) are known to have an increased risk of developing late treatment sequelae such as cardiovascular events due to coronary artery disease. At present no active screening is performed in these patients since it is not known whether screening and subsequent treatment by means of revascularization is effective in reducing the risk of cardiovascular events in symptomatic individuals. In the trial the efficacy and therapeutic consequences of screening for coronary artery diasease by multi-slice CT (MSCT) among asymptomatic HL survivors will be evaluated.
详细描述
Objectives:
- to determine whether MSCT as a screening method of HL survivors treated with mediastinal irradiation accurately identifies asymptomatic significant coronary artery disease.
- to establish the prevelance of coronary abnormalities in HL survivors treated with mediastinal irradiation
- to determine the frequency and type of intervention
- to evaluate the acceptance of screening and asses quality of life among Hl survivors.
Study polulation:
50 long term survivors of HL, previously treatef with mediastinal irradiation without present evidence of cardiovascular disease
Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of Hodgkin Lymphoma(all stages) with at least 10 disease free survival
- •current age between 35-60
- •mediastinal irradiation as part of HL treatment, radiotherapy data available
- •written informed consent
排除标准
- •current treatment for cardiovascualr disease, excelt hypertension hypercholesterolemia or cardiac murmurs
- •known or sypmtomatic heart failure
- •impaired kidney function (Cockcroft < 55 ml/min)
- •known contrast allergy
- •invasive angiography in past 2 years
- •presence of life threatening disorder
结局指标
主要结局
accurately identifying asymptomatic coronary artery disease
时间窗: one year
to determine whether Ct coronary angiography as a screening method acuurately identifies asymptomatic coronary artery disease in a high risk poulation (HL survivors after mediastinal irradiation)
次要结局
- prevalnce of cornary artery disease and frequency/type of subsequent intervention(one year)
研究者
L.A.Daniels
MD
Leiden University Medical Center