Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Fractional Anisotropy
研究概览
简要总结
Cognitive impairment is a known consequence of cerebral small-vessel disease. Moderate to severe cognitive impairment has been shown in up to 60% of certain individuals with COPD and is likely to profoundly influence an individual's ability to manage their disease.
In addition to cerebral small vessel damage and cognitive dysfunction, other organs such as the heart, kidneys, and retina are likely to be susceptible to small-vessel damage in COPD. Several large population studies have shown that COPD is a significant independent risk factor for myocardial infarction, with the effect most marked in early, mild disease.
We propose to compare non-invasive MR brain imaging of white matter microstructure (diffusion tensor), cerebral perfusion (arterial spin labelling) and accumulated cerebral small vessel disease (cerebral microbleeds), in COPD patients to smokers without COPD. In addition we plan to explore mechanisms of cerebral small vessel disease in COPD by looking for associations between arterial stiffness, end organ vascular damage and cognitive function.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must give their signed and dated written informed consent
- •Subjects must be aged >40 and ≤ 85
- •Subjects with a smoking history > 10 pack years.
- •COPD group: Subjects with a FEV/FVC <70%
排除标准
- •Resting oxygen saturations <92% on room air.
- •Long term oxygen therapy
- •Recent exacerbation of COPD (4 weeks)
- •Ischaemic heart disease
- •Cerebrovascular disease
- •Uncontrolled hypertension
- •Diabetes mellitus
- •Hepatic failure
- •Neurological disease
- •Non-cured tumours
- •Obstructive sleep apnoea
- •Current of past alcohol/drug abuse
- •Known history of dementia
- •Visual or hearing impairment that precludes neuropsychological assessment
- •Neuropsychological tests undertaken outside the study
- •Pregnant women or women who are lactating
- •Known alpha 1 anti-trypsin deficiency as a cause of their COPD
- •History of psychiatric disorders, or other conditions that will impact on the validity of their consent or interfere with compliance to perform study procedures.
- •Contra indication to MRI scanning -
结局指标
主要结局
Fractional Anisotropy
时间窗: upto 4 weeks
MRI Diffusion Imaging - measure of cerebral white matter microstructure
次要结局
- Cardiac MRI(upto 4 weeks)
- Aortic Pulse Wave Velocity(upto 4 weeks)
- Arterial Oxygen Saturation(upto 4 weeks)
- Cerebral Microbleeds(upto 4 weeks)
- Micro-albuminuria(upto 4 weeks)
- FEV1 % predicted(upto 4 weeks)
- Retinal Photography(upto 4 weeks)
- Health Status(upto 4 weeks)
- MRI Cerebral Perfusion - ASL(upto 4 weeks)
- Cognitive Function(upto 4 weeks)