NCT02060292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

2.3 years

First QC Date

November 29, 2013

Last Update Submit

June 26, 2018

Conditions

COPD

Keywords

COPDCognitive FunctionMRI BrainAortic StiffnessCerebrovascular disease

Outcome Measures

Primary Outcomes (1)

  • Fractional Anisotropy

    MRI Diffusion Imaging - measure of cerebral white matter microstructure

    upto 4 weeks

Secondary Outcomes (10)

  • Aortic Pulse Wave Velocity

    upto 4 weeks

  • MRI Cerebral Perfusion - ASL

    upto 4 weeks

  • Cerebral Microbleeds

    upto 4 weeks

  • Cognitive Function

    upto 4 weeks

  • Cardiac MRI

    upto 4 weeks

  • +5 more secondary outcomes

Other Outcomes (1)

  • Serum Inflammatory Markers

    upto 4 weeks

Study Arms (2)

COPD

Stable, Non hypoxaemic, without history of vascular disease

Healthy smokers

Age matched, smokers without COPD

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stable COPD

You may qualify if:

  • 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%

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Bristol NHS Trust

Bristol, Avon, BS10 5NB, United Kingdom

Location

Related Publications (1)

  • McKay GJ, McCarter RV, Hogg RE, Higbee DH, Bajaj MK, Burrage DR, Ruickbie S, Baker EH, Jones PW, Dodd JW. Simple non-mydriatic retinal photography is feasible and demonstrates retinal microvascular dilation in Chronic Obstructive Pulmonary Disease (COPD). PLoS One. 2020 Jan 10;15(1):e0227175. doi: 10.1371/journal.pone.0227175. eCollection 2020.

    PMID: 31923188DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • James W Dodd, MB ChB PhD

    University of Bristol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2013

First Posted

February 12, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

GB(1)