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

Cognitive Impairment Clinical Trial

— CInCH PAD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06369402
• Other study ID #: 0963
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: University of Leicester
• Contact: John SM Houghton
• Phone: +44 (0)116 2502645
• Email: jsmh2[@]le.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Diagnostic Test:
• 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).

Locations

Country	Name	City	State
United Kingdom	Glenfield Hospital Leicester	Leicester	Leicestershire

Sponsors (2)

Lead Sponsor	Collaborator
University of Leicester	University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Claudication distance	Distance to onset of pain in the six minute walk test	Baseline
Other	Maximal walking distance	Total distance walked during the six minute walk test	Baseline
Other	Ankle-brachial pressure index	Ratio of ankle blood pressure to the brachial blood pressure measured using handheld Doppler	Baseline
Primary	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	Autoregulation index (Tieck's model)	Change in response to performance of the ACE-III Cognitive Examination and Digit Span forward and backward.	Baseline
Secondary	Absolute score achieved on the Addenboook's cognitive examination (III)	Minimum score 0; Maximum score 100 (High scores indicate better cognitive performance)	Baseline
Secondary	Digit span forward and backward scores	Maximum list length correctly recalled and response consistency (total correct trials)	Baseline