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Completed

NCT Number: NCT02060292

Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease

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.

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Key information

Conditions

COPD Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Vascular Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

North Bristol NHS Trust

Bristol, Avon, BS10 5NB, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Primary outcomes

  1. Fractional Anisotropy

    Time frame: upto 4 weeks

    MRI Diffusion Imaging - measure of cerebral white matter microstructure

Secondary outcomes

  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 outcomes

  1. Serum Inflammatory Markers

    Time frame: upto 4 weeks

    Fibrinogen, C reacive Protein, IL-6

Sponsors and collaborators

Lead sponsor

North Bristol NHS Trust

Other

Registry information

Acronym: NOVASC COPD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 12, 2014
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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