Skip to content

Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease

Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02060292
Acronym
NOVASC COPD
Enrollment
55
Registered
2014-02-12
Start date
2014-04-30
Completion date
2016-07-31
Last updated
2018-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD, Cognitive Function, MRI Brain, Aortic Stiffness, Cerebrovascular disease

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.

Interventions

None listed

Sponsors

North Bristol NHS Trust
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
Yes

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 -

Design outcomes

Primary

MeasureTime frameDescription
Fractional Anisotropyupto 4 weeksMRI Diffusion Imaging - measure of cerebral white matter microstructure

Secondary

MeasureTime frameDescription
MRI Cerebral Perfusion - ASLupto 4 weeks
Cerebral Microbleedsupto 4 weeks
Cognitive Functionupto 4 weeksMontreal Cognitive Assessment
Cardiac MRIupto 4 weeksLV & RV Mass
FEV1 % predictedupto 4 weeks
Aortic Pulse Wave Velocityupto 4 weeksAortic stiffness
Retinal Photographyupto 4 weeksRetinal Arterial Narrowing
Micro-albuminuriaupto 4 weeksSpot urine albumin sample mg/l (milligram albumin per litre of urine)
Health Statusupto 4 weeksCOPD Assessment Test (CAT score) 0-40
Arterial Oxygen Saturationupto 4 weeks

Other

MeasureTime frameDescription
Serum Inflammatory Markersupto 4 weeksFibrinogen, C reacive Protein, IL-6

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026