Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease (NOVASC COPD)
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.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Avon
-
Bristol、Avon、イギリス、BS10 5NB
- North Bristol NHS Trust
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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 -
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
COPD
Stable, Non hypoxaemic, without history of vascular disease
|
|
Healthy smokers
Age matched, smokers without COPD
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fractional Anisotropy
時間枠：upto 4 weeks
|
MRI Diffusion Imaging - measure of cerebral white matter microstructure
|
upto 4 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Aortic Pulse Wave Velocity
時間枠：upto 4 weeks
|
Aortic stiffness
|
upto 4 weeks
|
|
MRI Cerebral Perfusion - ASL
時間枠：upto 4 weeks
|
upto 4 weeks
|
|
|
Cerebral Microbleeds
時間枠：upto 4 weeks
|
upto 4 weeks
|
|
|
Cognitive Function
時間枠：upto 4 weeks
|
Montreal Cognitive Assessment
|
upto 4 weeks
|
|
Cardiac MRI
時間枠：upto 4 weeks
|
LV & RV Mass
|
upto 4 weeks
|
|
FEV1 % predicted
時間枠：upto 4 weeks
|
upto 4 weeks
|
|
|
Arterial Oxygen Saturation
時間枠：upto 4 weeks
|
upto 4 weeks
|
|
|
Retinal Photography
時間枠：upto 4 weeks
|
Retinal Arterial Narrowing
|
upto 4 weeks
|
|
Micro-albuminuria
時間枠：upto 4 weeks
|
Spot urine albumin sample mg/l (milligram albumin per litre of urine)
|
upto 4 weeks
|
|
Health Status
時間枠：upto 4 weeks
|
COPD Assessment Test (CAT score) 0-40
|
upto 4 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum Inflammatory Markers
時間枠：upto 4 weeks
|
Fibrinogen, C reacive Protein, IL-6
|
upto 4 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：James W Dodd, MB ChB PhD、University of Bristol
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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