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Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease

Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06369402
Acronym
CInCH PAD
Enrollment
40
Registered
2024-04-17
Start date
2024-05-22
Completion date
2025-07-31
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease, Cognitive Impairment

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.

Interventions

DIAGNOSTIC_TESTCerebral 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.

DIAGNOSTIC_TESTAnkle-brachial pressure index

Ratio of ankle to brachial blood pressure measured using handheld Doppler at rest and after exercise (six-minute walk test).

DIAGNOSTIC_TESTSix-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).

Sponsors

University Hospitals, Leicester
CollaboratorOTHER
University of Leicester
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Peak % change of CBv from baselineBaselineChange in response to performance of the ACE-III Cognitive Examination and Digit Span forward and backward.

Secondary

MeasureTime frameDescription
Autoregulation index (Tieck's model)BaselineChange 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)BaselineMinimum score 0; Maximum score 100 (High scores indicate better cognitive performance)
Digit span forward and backward scoresBaselineMaximum list length correctly recalled and response consistency (total correct trials)

Other

MeasureTime frameDescription
Maximal walking distanceBaselineTotal distance walked during the six minute walk test
Ankle-brachial pressure indexBaselineRatio of ankle blood pressure to the brachial blood pressure measured using handheld Doppler
Claudication distanceBaselineDistance to onset of pain in the six minute walk test

Countries

United Kingdom

Contacts

Primary ContactJohn SM Houghton
jsmh2@le.ac.uk+44 (0)116 2502645
Backup ContactTanya J Payne
tjp28@le.ac.uk+44 (0)116 2502645

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026