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

NCT06369402 | Recruiting

• 1 other identifier: 0963
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Peak % change of CBv from baseline

  Change in response to performance of the ACE-III Cognitive Examination and Digit Span forward and backward.

  Baseline

Secondary Outcomes (3)

• Autoregulation index (Tieck's model)

  Baseline

• Absolute score achieved on the Addenboook's cognitive examination (III)

  Baseline

• Digit span forward and backward scores

  Baseline

Other Outcomes (3)

• Claudication distance

  Baseline

• Maximal walking distance

  Baseline

• Ankle-brachial pressure index

  Baseline

Study Arms (2)

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.

Diagnostic Test: Cerebral haemodynamic testing using transcranial Doppler; Diagnostic Test: Ankle-brachial pressure index; Diagnostic Test: Six-minute walk test

Healthy controls

Age- and sex-matched cohort of individuals without peripheral arterial disease.

Diagnostic Test: Cerebral haemodynamic testing using transcranial Doppler; Diagnostic Test: Ankle-brachial pressure index; Diagnostic Test: Six-minute walk test

Interventions

Cerebral haemodynamic testing using transcranial Doppler DIAGNOSTIC_TEST

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.

Healthy controls; Individuals with symptomatic peripheral arterial disease

Ankle-brachial pressure index DIAGNOSTIC_TEST

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

Healthy controls; Individuals with symptomatic peripheral arterial disease

Six-minute walk test DIAGNOSTIC_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; Individuals with symptomatic peripheral arterial disease

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• Symptoms of intermittent claudication; and/or,
• Clinical diagnosis or history of PAD

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator

Study Sites (1)

Glenfield Hospital Leicester

Leicester, Leicestershire, LE3 9QP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Cognitive Dysfunction

Interventions

Ankle Brachial Index; Walk Test

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Exercise Test; Heart Function Tests

Study Officials

• Rob D Sayers, MD

  University of Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John SM Houghton

CONTACT

+44 (0)116 2502645; jsmh2@le.ac.uk

Tanya J Payne

CONTACT

+44 (0)116 2502645; tjp28@le.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: May 22, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: Access upon request to the study Chief Investigator (Prof R Sayers).

Locations

GB (1)