跳至主要内容
临床试验/NCT01239446
NCT01239446Unknown不适用

Hybrid Single-Photon Emission Computed Tomography/Computed Tomography Coronary Angiography for the Assessment of the Presence and Hemodynamic Significance of CAD in Asymptomatic Patients After Mediastinal Irradiation for Hodgkin Lymphoma.

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Extent of coronary artery plaques and number of perfusion defects in patients enrolled.

研究概览

简要总结

Mediastinal irradiation for treatment of malignancy increases the risk for coronary artery disease (CAD), while diabetes mellitus or other known risk factors can be absent at the time of the first coronary event. Radiation-induced atherosclerosis affects the coronary ostia and proximal coronary segments, or causes diffuse microvascular damage. Younger patients and those exposed to high radiation doses (> 35 Gy) have a higher risk for developing premature CAD and likely may benefit from coronary assessment.

A novel hybrid imaging technique that combines SPECT and CTCA has been shown to overcome the individual pitfalls and the diagnostic challenges of stand-alone SPECT and CCTA, improve the lesion detectability and sensitivity in patients with balanced diffuse lesions as well as the specificity and mainly PPV of CTCA.

The aim of the study is to perform hybrid SPECT/CTCA in asymptomatic patients with HL who have received radiotherapy to the mediastinum in order to allow an early diagnosis of hemodynamically significant CAD that will need further therapeutic interventions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Asymptomatic HL patients without evidence of disease and without prior history of CAD that underwent mediastinal irradiation due to HL

排除标准

  • Known CAD (these patients will be excluded from the imaging study, but will be analyzed as separate control group)
  • active HL or other active malignancy
  • chronic renal failure
  • pregnant/ nursing women
  • previous allergic reaction to iodine contrast media

结局指标

主要结局

Extent of coronary artery plaques and number of perfusion defects in patients enrolled.

时间窗: 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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