COPDNOVASC COPDNCT02060292
Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease
An observational study of COPD, run by North Bristol NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stable COPD
Who may be able to join
- 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%
Who cannot join
- Resting oxygen saturations <92% on room air.
- Long term oxygen therapy
- Recent exacerbation of COPD (4 weeks)
- Ischaemic heart disease
- Cerebrovascular disease
- Uncontrolled hypertension
Show all 19Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- COPD
- Keywords
- COPD, Cognitive Function, MRI Brain, Aortic Stiffness, Cerebrovascular disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD | Stable, Non hypoxaemic, without history of vascular disease | |
| Healthy smokers | Age matched, smokers without COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Anisotropy
MRI Diffusion Imaging - measure of cerebral white matter microstructure
Measured: upto 4 weeks
Secondary outcomes (10)
Aortic Pulse Wave Velocity
Aortic stiffness
Measured: upto 4 weeks
MRI Cerebral Perfusion - ASL
Measured: upto 4 weeks
Cerebral Microbleeds
Measured: upto 4 weeks
Cognitive Function
Montreal Cognitive Assessment
Measured: upto 4 weeks
Cardiac MRI
LV \& RV Mass
Measured: upto 4 weeks
FEV1 % predicted
Measured: upto 4 weeks
Arterial Oxygen Saturation
Measured: upto 4 weeks
Retinal Photography
Retinal Arterial Narrowing
Measured: upto 4 weeks
Micro-albuminuria
Spot urine albumin sample mg/l (milligram albumin per litre of urine)
Measured: upto 4 weeks
Health Status
COPD Assessment Test (CAT score) 0-40
Measured: upto 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Bristol NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James W Dodd, MB ChB PhD, Principal investigator, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060292
- Sponsor's protocol ID
- 3251
- Acronym
- NOVASC COPD
- Status last verified
- Jun 2018
- First submitted
- 29 Nov 2013
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31923188
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02060292
- Acronym / sponsor ID
- NOVASC COPD / 3251
- Conditions
- COPD
- Keywords
- COPD, Cognitive Function, MRI Brain, Aortic Stiffness, Cerebrovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- North Bristol NHS TrustUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD | – | –Stable, Non hypoxaemic, without history of vascular disease |
| Healthy smokers | – | –Age matched, smokers without COPD |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stable COPD
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (19 listed)
- Resting oxygen saturations <92% on room air.
- Long term oxygen therapy
- Recent exacerbation of COPD (4 weeks)
- Ischaemic heart disease
- Cerebrovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fractional Anisotropy
Time frame: upto 4 weeks
MRI Diffusion Imaging - measure of cerebral white matter microstructure
10 secondary outcomes
Aortic Pulse Wave Velocity
Time frame: upto 4 weeks
MRI Cerebral Perfusion - ASL
Time frame: upto 4 weeks
Cerebral Microbleeds
Time frame: upto 4 weeks
Cognitive Function
Time frame: upto 4 weeks
Cardiac MRI
Time frame: upto 4 weeks
FEV1 % predicted
Time frame: upto 4 weeks
Arterial Oxygen Saturation
Time frame: upto 4 weeks
Retinal Photography
Time frame: upto 4 weeks
Micro-albuminuria
Time frame: upto 4 weeks
Health Status
Time frame: upto 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Derived from this study: PubMed 31923188McKay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James W Dodd, MB ChB PhD principal investigator
University of Bristol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by North Bristol NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional Anisotropy (time frame: upto 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02060292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.