Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease
NCT ID: NCT06369402
Last Updated: 2024-12-09
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
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RECRUITING
40 participants
OBSERVATIONAL
2024-05-22
2025-07-31
Brief Summary
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Arterial disease of the legs causes symptoms such as pain when walking and may ultimately lead to a leg amputation. Many older people with arterial disease of the legs also have problems with their thinking and memory. Blood flow in the brain may be altered in these people and may be a cause for memory and thinking problems.
Aim:
The aim of this project is to investigate whether people with arterial disease of the legs have altered blood flow in the brain causing problems with memory and thinking.
Research plan:
Twenty people with arterial disease of the legs causing pain while walking and twenty healthy people will have a series of non-invasive assessments. Arterial disease in the legs will be measured using ankle blood pressures before and after walking. Blood flow in the brain will be measured using ultrasound whilst performing memory and thinking tests. Results will be compared between the people with arterial disease in the legs and the healthy people to see if there are any differences in blood flow to the brain and memory and thinking.
Benefits to society:
This project will help determine if there is a link between arterial disease of the legs and memory and thinking problems caused by altered blood flow in the brain. It will enable future research in people with cognitive impairment caused by altered blood supply to the brain and to prevent confusion and further memory and thinking problems in people undergoing surgery for arterial disease of the legs.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Individuals with symptomatic peripheral arterial disease
Individuals with intermittent claudication caused by confirmed peripheral arterial disease defined as a resting ankle-brachial pressure index of \<0.9 and/or a post-exercise reduction in either ankle-brachial pressure index of \>20% or absolute ankle pressure of \>30mmHg.
Cerebral haemodynamic testing using transcranial Doppler
Measurement of cerebral haemodynamics using transcranial Doppler to insonate the middle cerebral arteries bilaterally testing neurovascular coupling with selected domains from the Addenbrooks cognitive examination III and the digit span forward and backwards.
Ankle-brachial pressure index
Ratio of ankle to brachial blood pressure measured using handheld Doppler at rest and after exercise (six-minute walk test).
Six-minute walk test
Supervised brisk walk for six minutes. Time and distance to onset of claudication pain and total distance walked (and total time walked if did not complete the full six minutes).
Healthy controls
Age- and sex-matched cohort of individuals without peripheral arterial disease.
Cerebral haemodynamic testing using transcranial Doppler
Measurement of cerebral haemodynamics using transcranial Doppler to insonate the middle cerebral arteries bilaterally testing neurovascular coupling with selected domains from the Addenbrooks cognitive examination III and the digit span forward and backwards.
Ankle-brachial pressure index
Ratio of ankle to brachial blood pressure measured using handheld Doppler at rest and after exercise (six-minute walk test).
Six-minute walk test
Supervised brisk walk for six minutes. Time and distance to onset of claudication pain and total distance walked (and total time walked if did not complete the full six minutes).
Interventions
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Cerebral haemodynamic testing using transcranial Doppler
Measurement of cerebral haemodynamics using transcranial Doppler to insonate the middle cerebral arteries bilaterally testing neurovascular coupling with selected domains from the Addenbrooks cognitive examination III and the digit span forward and backwards.
Ankle-brachial pressure index
Ratio of ankle to brachial blood pressure measured using handheld Doppler at rest and after exercise (six-minute walk test).
Six-minute walk test
Supervised brisk walk for six minutes. Time and distance to onset of claudication pain and total distance walked (and total time walked if did not complete the full six minutes).
Eligibility Criteria
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Inclusion Criteria
* Male or female, aged ≥50 years of age
* Able (in the Investigator's opinion) and willing to comply with all study requirements
* Good understanding of written and verbal English
* Clinical diagnosis of symptomatic PAD (intermittent claudication) confirmed by positive haemodynamic tests (ABPI \<0.90 in the symptomatic leg; and/or,
* Post-exercise \[walk test\] reduction in ABPI of \>20% or post-exercise \[walk test\] reduction in absolute ankle pressure of \>30mmHg)
Exclusion Criteria
* Pregnant
* Unable (in the Investigator's opinion) or unwilling to comply with any study requirements
* Major co-morbidity likely to affect cerebral autoregulation; severe respiratory disease, unilateral carotid artery stenosis (≥50%), atrial fibrillation, severe cardiac failure (left ventricular ejection fraction \<20%), or extreme frailty
* History of significant diagnosed psychiatric disorder, learning disability (e.g. dyslexia) or neurological disorder (head injury, epilepsy, stroke and/or transient ischaemic attack \[TIA\])
* Diagnosis of dementia
* Uncorrected hearing impairment and/or significant visual impairment
* Symptoms of intermittent claudication; and/or,
* Clinical diagnosis or history of PAD
50 Years
ALL
No
Sponsors
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University Hospitals, Leicester
OTHER
University of Leicester
OTHER
Responsible Party
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Principal Investigators
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Rob D Sayers, MD
Role: PRINCIPAL_INVESTIGATOR
University of Leicester
Locations
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Glenfield Hospital Leicester
Leicester, Leicestershire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Tanya J Payne
Role: primary
Other Identifiers
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0963
Identifier Type: -
Identifier Source: org_study_id