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Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease (NOVASC COPD)

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ClinicalTrials.gov Identifier: NCT02060292
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
North Bristol NHS Trust

Brief 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.


Condition or disease
COPD

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease
Study Start Date : April 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Group/Cohort
COPD
Stable, Non hypoxaemic, without history of vascular disease
Healthy smokers
Age matched, smokers without COPD



Primary Outcome Measures :
  1. Fractional Anisotropy [ Time Frame: upto 4 weeks ]
    MRI Diffusion Imaging - measure of cerebral white matter microstructure


Secondary Outcome Measures :
  1. Aortic Pulse Wave Velocity [ Time Frame: upto 4 weeks ]
    Aortic stiffness

  2. MRI Cerebral Perfusion - ASL [ Time Frame: upto 4 weeks ]
  3. Cerebral Microbleeds [ Time Frame: upto 4 weeks ]
  4. Cognitive Function [ Time Frame: upto 4 weeks ]
    Montreal Cognitive Assessment

  5. Cardiac MRI [ Time Frame: upto 4 weeks ]
    LV & RV Mass

  6. FEV1 % predicted [ Time Frame: upto 4 weeks ]
  7. Arterial Oxygen Saturation [ Time Frame: upto 4 weeks ]
  8. Retinal Photography [ Time Frame: upto 4 weeks ]
    Retinal Arterial Narrowing

  9. Micro-albuminuria [ Time Frame: upto 4 weeks ]
    Spot urine albumin sample mg/l (milligram albumin per litre of urine)

  10. Health Status [ Time Frame: upto 4 weeks ]
    COPD Assessment Test (CAT score) 0-40


Other Outcome Measures:
  1. Serum Inflammatory Markers [ Time Frame: upto 4 weeks ]
    Fibrinogen, C reacive Protein, IL-6


Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Stable COPD
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060292


Locations
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United Kingdom
North Bristol NHS Trust
Bristol, Avon, United Kingdom, BS10 5NB
Sponsors and Collaborators
North Bristol NHS Trust
Investigators
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Principal Investigator: James W Dodd, MB ChB PhD University of Bristol

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Responsible Party: North Bristol NHS Trust
ClinicalTrials.gov Identifier: NCT02060292     History of Changes
Other Study ID Numbers: 3251
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

Keywords provided by North Bristol NHS Trust:
COPD
Cognitive Function
MRI Brain
Aortic Stiffness
Cerebrovascular disease

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases