Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

— NOVASC COPD  

Official title:

Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060292
• Other study ID #: 3251
• Status: Completed
• Start date: April 2014
• Est. completion date: July 2016

Study information

• Verified date: June 2018
• Source: North Bristol NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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 -

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	North Bristol NHS Trust	Bristol	Avon

Sponsors (1)

Lead Sponsor	Collaborator
North Bristol NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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