COPD Clinical Trial
— NOVASC COPDOfficial title:
Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease
NCT number | NCT02060292 |
Other study ID # | 3251 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2014 |
Est. completion date | July 2016 |
Verified date | June 2018 |
Source | North Bristol NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility |
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 - |
Country | Name | City | State |
---|---|---|---|
United Kingdom | North Bristol NHS Trust | Bristol | Avon |
Lead Sponsor | Collaborator |
---|---|
North Bristol NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Serum Inflammatory Markers | Fibrinogen, C reacive Protein, IL-6 | upto 4 weeks | |
Primary | Fractional Anisotropy | MRI Diffusion Imaging - measure of cerebral white matter microstructure | upto 4 weeks | |
Secondary | Aortic Pulse Wave Velocity | Aortic stiffness | upto 4 weeks | |
Secondary | MRI Cerebral Perfusion - ASL | upto 4 weeks | ||
Secondary | Cerebral Microbleeds | upto 4 weeks | ||
Secondary | Cognitive Function | Montreal Cognitive Assessment | upto 4 weeks | |
Secondary | Cardiac MRI | LV & RV Mass | upto 4 weeks | |
Secondary | FEV1 % predicted | upto 4 weeks | ||
Secondary | Arterial Oxygen Saturation | upto 4 weeks | ||
Secondary | Retinal Photography | Retinal Arterial Narrowing | upto 4 weeks | |
Secondary | Micro-albuminuria | Spot urine albumin sample mg/l (milligram albumin per litre of urine) | upto 4 weeks | |
Secondary | Health Status | COPD Assessment Test (CAT score) 0-40 | upto 4 weeks |
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