NCT03487302已完成不适用
Assessment of White Matter Hyperintensities Burden in Adult Patients With Cyanotic Congenital Heart Disease: a Pilot Study
IRCCS Policlinico S. Donato1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2017年10月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- White matter hyperintensities volume expressed in mm^3
研究概览
简要总结
The study aims at investigating the role of cyanotic congenital heart disease (cCHD) on brain aging. The investigators assume that due to congenital and acquired cardiovascular abnormalities, cCHD patients could show radiologic (and clinical) signs of precocious brain aging and eventual cognitive decline.
详细描述
White matter hyperintensities burden will be quantified through a semi-autamated software (ITK-SNAP)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for the patient group, being an adult subject affected with cyanotic congenital heart disease, whether surgically corrected or not.
- •for the control group, being an healthy subject.
排除标准
- •any contraindication to magnetic resonance imaging;
- •any pathological condition and/or symptomp that could alter the white matter hyperintensities burden, among which:
- •inflammatory, infectious, demyelinating or dysmyelinating diseases of the CNS;
- •ischemic, haemorrhagic or traumatic brain events and eventual gliotic and malacic or lacunar sequelae;
- •genetic diseases (whether mendelian or mitochondrial) of the CNS;
- •cerebral amyloid angiopathy;
- •cerebral arteriovenous malformations;
- •primary or metastatic brain neoplasms which cause neurological symptoms and/or brain parenchymal sequelae from surgical excision;
- •patent oval foramen;
- •being pregnant;
- •migraine with aura (Bashir, Lipton, Ashina, & Ashina, 2013).
结局指标
主要结局
White matter hyperintensities volume expressed in mm^3
时间窗: 3 years
Semi-automated quantification performed through ITK-SNAP
次要结局
未报告次要终点
研究者
Francesco Sardanelli
Principal Investigator
IRCCS Policlinico S. Donato
研究点 (1)
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