Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease

Completed

• Conditions: COPD

• Registration Number: NCT02060292
• Lead Sponsor: North Bristol NHS Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-29
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-12
• Study Start: 2014-04
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Subjects must give their signed and dated written informed consent
2. Subjects must be aged >40 and ≤ 85
3. Subjects with a smoking history > 10 pack years.
4. COPD group: Subjects with a FEV/FVC <70%

Exclusion Criteria

1. Resting oxygen saturations <92% on room air.
2. Long term oxygen therapy
3. Recent exacerbation of COPD (4 weeks)
4. Ischaemic heart disease
5. Cerebrovascular disease
6. Uncontrolled hypertension
7. Diabetes mellitus
8. Hepatic failure
9. Neurological disease
10. Non-cured tumours
11. Obstructive sleep apnoea
12. Current of past alcohol/drug abuse
13. Known history of dementia
14. Visual or hearing impairment that precludes neuropsychological assessment
15. Neuropsychological tests undertaken outside the study
16. Pregnant women or women who are lactating
17. Known alpha 1 anti-trypsin deficiency as a cause of their COPD
18. History of psychiatric disorders, or other conditions that will impact on the validity of their consent or interfere with compliance to perform study procedures.
19. Contra indication to MRI scanning -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fractional Anisotropy	upto 4 weeks	MRI Diffusion Imaging - measure of cerebral white matter microstructure

Secondary Outcome Measures

Name	Time	Method
Cardiac MRI	upto 4 weeks	LV \& RV Mass
Aortic Pulse Wave Velocity	upto 4 weeks	Aortic stiffness
Arterial Oxygen Saturation	upto 4 weeks
Cerebral Microbleeds	upto 4 weeks
Micro-albuminuria	upto 4 weeks	Spot urine albumin sample mg/l (milligram albumin per litre of urine)
FEV1 % predicted	upto 4 weeks
Retinal Photography	upto 4 weeks	Retinal Arterial Narrowing
Health Status	upto 4 weeks	COPD Assessment Test (CAT score) 0-40
MRI Cerebral Perfusion - ASL	upto 4 weeks
Cognitive Function	upto 4 weeks	Montreal Cognitive Assessment

Trial Locations

Locations (1)

North Bristol NHS Trust; 🇬🇧 Bristol, Avon, United Kingdom