Clinical trial NCT02060292: Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease
Official title: Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD
Cognitive Function
MRI Brain
Aortic Stiffness
Cerebrovascular disease
Lead sponsor: North Bristol NHS Trust
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 55
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable COPD

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.


Eligibility criteria: 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 -

Primary outcomes:
measure: Fractional Anisotropy
timeFrame: upto 4 weeks
Secondary outcomes:
measure: Aortic Pulse Wave Velocity
timeFrame: upto 4 weeks
measure: MRI Cerebral Perfusion - ASL
timeFrame: upto 4 weeks
measure: Cerebral Microbleeds
timeFrame: upto 4 weeks
measure: Cognitive Function
timeFrame: upto 4 weeks
measure: Cardiac MRI
timeFrame: upto 4 weeks
measure: FEV1 % predicted
timeFrame: upto 4 weeks
measure: Arterial Oxygen Saturation
timeFrame: upto 4 weeks
measure: Retinal Photography
timeFrame: upto 4 weeks
measure: Micro-albuminuria
timeFrame: upto 4 weeks
measure: Health Status
timeFrame: upto 4 weeks
Other outcomes:
measure: Serum Inflammatory Markers
timeFrame: upto 4 weeks
Locations:
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
state: Avon
Study officials:
affiliation: University of Bristol
name: James W Dodd, MB ChB PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McKay GJ, McCarter RV, Hogg RE, Higbee DH, Bajaj MK, Burrage DR, Ruickbie S, Baker EH, Jones PW, Dodd JW. Simple non-mydriatic retinal photography is feasible and demonstrates retinal microvascular dilation in Chronic Obstructive Pulmonary Disease (COPD). PLoS One. 2020 Jan 10;15(1):e0227175. doi: 10.1371/journal.pone.0227175. eCollection 2020.