Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease (NOVASC COPD)
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Avon
-
Bristol, Avon, Storbritannia, BS10 5NB
- North Bristol NHS Trust
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Subjects must give their signed and dated written informed consent
- Subjects must be aged >40 and ≤ 85
- Subjects with a smoking history > 10 pack years.
- COPD group: Subjects with a FEV/FVC <70%
Exclusion Criteria:
- Resting oxygen saturations <92% on room air.
- Long term oxygen therapy
- Recent exacerbation of COPD (4 weeks)
- Ischaemic heart disease
- Cerebrovascular disease
- Uncontrolled hypertension
- Diabetes mellitus
- Hepatic failure
- Neurological disease
- Non-cured tumours
- Obstructive sleep apnoea
- Current of past alcohol/drug abuse
- Known history of dementia
- Visual or hearing impairment that precludes neuropsychological assessment
- Neuropsychological tests undertaken outside the study
- Pregnant women or women who are lactating
- Known alpha 1 anti-trypsin deficiency as a cause of their COPD
- History of psychiatric disorders, or other conditions that will impact on the validity of their consent or interfere with compliance to perform study procedures.
- Contra indication to MRI scanning -
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
COPD
Stable, Non hypoxaemic, without history of vascular disease
|
|
Healthy smokers
Age matched, smokers without COPD
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fractional Anisotropy
Tidsramme: upto 4 weeks
|
MRI Diffusion Imaging - measure of cerebral white matter microstructure
|
upto 4 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Aortic Pulse Wave Velocity
Tidsramme: upto 4 weeks
|
Aortic stiffness
|
upto 4 weeks
|
|
MRI Cerebral Perfusion - ASL
Tidsramme: upto 4 weeks
|
upto 4 weeks
|
|
|
Cerebral Microbleeds
Tidsramme: upto 4 weeks
|
upto 4 weeks
|
|
|
Cognitive Function
Tidsramme: upto 4 weeks
|
Montreal Cognitive Assessment
|
upto 4 weeks
|
|
Cardiac MRI
Tidsramme: upto 4 weeks
|
LV & RV Mass
|
upto 4 weeks
|
|
FEV1 % predicted
Tidsramme: upto 4 weeks
|
upto 4 weeks
|
|
|
Arterial Oxygen Saturation
Tidsramme: upto 4 weeks
|
upto 4 weeks
|
|
|
Retinal Photography
Tidsramme: upto 4 weeks
|
Retinal Arterial Narrowing
|
upto 4 weeks
|
|
Micro-albuminuria
Tidsramme: upto 4 weeks
|
Spot urine albumin sample mg/l (milligram albumin per litre of urine)
|
upto 4 weeks
|
|
Health Status
Tidsramme: upto 4 weeks
|
COPD Assessment Test (CAT score) 0-40
|
upto 4 weeks
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum Inflammatory Markers
Tidsramme: upto 4 weeks
|
Fibrinogen, C reacive Protein, IL-6
|
upto 4 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: James W Dodd, MB ChB PhD, University of Bristol
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 3251
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