Clinical trial NCT06369402: Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease
Official title: Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Cognitive Impairment
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2024-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of individuals with symptomatic peripheral arterial disease (intermittent claudication) with an age- and sex-matched healthy control cohort.

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Peak % change of CBv from baseline
timeFrame: Baseline
Secondary outcomes:
measure: Autoregulation index (Tieck's model)
timeFrame: Baseline
measure: Absolute score achieved on the Addenboook's cognitive examination (III)
timeFrame: Baseline
measure: Digit span forward and backward scores
timeFrame: Baseline
Other outcomes:
measure: Claudication distance
timeFrame: Baseline
measure: Maximal walking distance
timeFrame: Baseline
measure: Ankle-brachial pressure index
timeFrame: Baseline
Locations:
city: Leicester
country: United Kingdom
facility: Glenfield Hospital Leicester
state: Leicestershire
Study officials:
affiliation: University of Leicester
name: Rob D Sayers, MD
role: PRINCIPAL_INVESTIGATOR
References: