- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02060292
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Avon
-
Bristol, Avon, Det Forenede Kongerige, BS10 5NB
- North Bristol NHS Trust
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
COPD
Stable, Non hypoxaemic, without history of vascular disease
|
Healthy smokers
Age matched, smokers without COPD
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Fractional Anisotropy
Tidsramme: upto 4 weeks
|
MRI Diffusion Imaging - measure of cerebral white matter microstructure
|
upto 4 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Serum Inflammatory Markers
Tidsramme: upto 4 weeks
|
Fibrinogen, C reacive Protein, IL-6
|
upto 4 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: James W Dodd, MB ChB PhD, University of Bristol
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 3251
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