Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease
NCT ID: NCT02060292
Last Updated: 2018-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
55 participants
OBSERVATIONAL
2014-04-30
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
COPD-Related Physiology and the Brain
NCT03269721
Cerebral and Cardiac Blood Flow During Exercise in Patients With COPD
NCT04138563
Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease
NCT06072690
Pulmonary Vasculature and Right Heart Dysfunction in Chronic Obstructive Pulmonay Disease
NCT03184727
Cognitive Impairment in COPD Patients
NCT04394299
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
COPD
Stable, Non hypoxaemic, without history of vascular disease
No interventions assigned to this group
Healthy smokers
Age matched, smokers without COPD
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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 -
40 Years
85 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
North Bristol NHS Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James W Dodd, MB ChB PhD
Role: PRINCIPAL_INVESTIGATOR
University of Bristol
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
North Bristol NHS Trust
Bristol, Avon, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3251
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.