Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease
- Conditions
- Cognitive ImpairmentPeripheral Arterial Disease
- Interventions
- Diagnostic Test: Cerebral haemodynamic testing using transcranial DopplerDiagnostic Test: Ankle-brachial pressure indexDiagnostic Test: Six-minute walk test
- Registration Number
- NCT06369402
- Lead Sponsor
- University of Leicester
- Brief Summary
Background:
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
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Capacity to provide Informed volunteer/patient consent
- 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
Peripheral arterial disease specific inclusion criteria:
- 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)
- Male or Female, aged under 50 years
- 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
Healthy control specific exclusion criteria
- Symptoms of intermittent claudication; and/or,
- Clinical diagnosis or history of PAD
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Individuals with symptomatic peripheral arterial disease Ankle-brachial pressure index 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. Individuals with symptomatic peripheral arterial disease Six-minute walk test 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. Healthy controls Cerebral haemodynamic testing using transcranial Doppler Age- and sex-matched cohort of individuals without peripheral arterial disease. Individuals with symptomatic peripheral arterial disease Cerebral haemodynamic testing using transcranial Doppler 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. Healthy controls Ankle-brachial pressure index Age- and sex-matched cohort of individuals without peripheral arterial disease. Healthy controls Six-minute walk test Age- and sex-matched cohort of individuals without peripheral arterial disease.
- Primary Outcome Measures
Name Time Method Peak % change of CBv from baseline Baseline Change in response to performance of the ACE-III Cognitive Examination and Digit Span forward and backward.
- Secondary Outcome Measures
Name Time Method Autoregulation index (Tieck's model) Baseline Change in response to performance of the ACE-III Cognitive Examination and Digit Span forward and backward.
Absolute score achieved on the Addenboook's cognitive examination (III) Baseline Minimum score 0; Maximum score 100 (High scores indicate better cognitive performance)
Digit span forward and backward scores Baseline Maximum list length correctly recalled and response consistency (total correct trials)
Trial Locations
- Locations (1)
Glenfield Hospital Leicester
🇬🇧Leicester, Leicestershire, United Kingdom