Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2016

Arms, Groups and Cohorts

  • COPD
    • Stable, Non hypoxaemic, without history of vascular disease
  • Healthy smokers
    • Age matched, smokers without COPD

Clinical Trial Outcome Measures

Primary Measures

  • Fractional Anisotropy
    • Time Frame: upto 4 weeks
    • MRI Diffusion Imaging – measure of cerebral white matter microstructure

Secondary Measures

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

Participating in This Clinical Trial

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 -

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • North Bristol NHS Trust
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • James W Dodd, MB ChB PhD, Principal Investigator, University of Bristol

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