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Clinical Trials/NCT02060292
NCT02060292
Completed
Not Applicable

Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease

North Bristol NHS Trust1 site in 1 country55 target enrollmentApril 2014
ConditionsCOPD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
North Bristol NHS Trust
Enrollment
55
Locations
1
Primary Endpoint
Fractional Anisotropy
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
July 2016
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Fractional Anisotropy

Time Frame: upto 4 weeks

MRI Diffusion Imaging - measure of cerebral white matter microstructure

Secondary Outcomes

  • Cardiac MRI(upto 4 weeks)
  • Aortic Pulse Wave Velocity(upto 4 weeks)
  • Arterial Oxygen Saturation(upto 4 weeks)
  • Cerebral Microbleeds(upto 4 weeks)
  • Micro-albuminuria(upto 4 weeks)
  • FEV1 % predicted(upto 4 weeks)
  • Retinal Photography(upto 4 weeks)
  • Health Status(upto 4 weeks)
  • MRI Cerebral Perfusion - ASL(upto 4 weeks)
  • Cognitive Function(upto 4 weeks)

Study Sites (1)

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