Peripheral Arterial DiseaseCInCH PADNCT06369402
Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease
An observational study of Peripheral Arterial Disease and Cognitive Impairment, run by University of Leicester at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Cognitive Impairment
- What is being tested?
- Cerebral haemodynamic testing using transcranial Doppler, Ankle-brachial pressure index and Six-minute walk test
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2024to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Study population: A cohort of individuals with symptomatic peripheral arterial disease (intermittent claudication) with an age- and sex-matched healthy control cohort.
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Glenfield Hospital Leicester
Leicester, Leicestershire, LE3 9QP
Tanya J Payne, +44 (0)116 358 3867, tjp28@le.ac.uk
Rob D Sayers, MD
About this study
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.
Read more
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
- Being tested
- Cerebral haemodynamic testing using transcranial Doppler, Ankle-brachial pressure index, Six-minute walk test
- Medical subject headings
- Peripheral Arterial Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral haemodynamic testing using transcranial DopplerDiagnostic 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.
Ankle-brachial pressure indexDiagnostic test
Ratio of ankle to brachial blood pressure measured using handheld Doppler at rest and after exercise (six-minute walk test).
Six-minute walk testDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Cerebral haemodynamic testing using transcranial Doppler; Diagnostic Test: Ankle-brachial pressure index; Diagnostic Test: Six-minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak % change of CBv from baseline
Change in response to performance of the ACE-III Cognitive Examination and Digit Span forward and backward.
Measured: Baseline
Secondary outcomes (3)
Autoregulation index (Tieck's model)
Change in response to performance of the ACE-III Cognitive Examination and Digit Span forward and backward.
Measured: Baseline
Absolute score achieved on the Addenboook's cognitive examination (III)
Minimum score 0; Maximum score 100 (High scores indicate better cognitive performance)
Measured: Baseline
Digit span forward and backward scores
Maximum list length correctly recalled and response consistency (total correct trials)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start22 May 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
- Investigators
- Rob D Sayers, MD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369402
- Sponsor's protocol ID
- 0963
- Acronym
- CInCH PAD
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully-anonymised electronic data will be stored in the Cerebral Haemodynamics in ageing and Stroke Medicine research database for 25 years and will be made available via the University of Leicester data repository (https://leicester.figshare.com/) for a minimum of 10 years.
Publications
Cheshire BL, Sensier YJ, Beishon LC, Panerai RB, Sayers RD, Houghton JSM. Cognitive impairment and cerebral hemodynamics in individuals with symptomatic peripheral artery disease. Am J Physiol Heart Circ Physiol. 2026 Nov 1;331(5):H2004-H2013. doi: 10.1152/ajpheart.00634.2026. Epub 2026 Sep 29.
PubMed 42809627
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT06369402
- Acronym / sponsor ID
- CInCH PAD / 0963
- Conditions
- Peripheral Arterial Disease, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 22 May 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with symptomatic peripheral arterial disease | – | Diagnostic Test: Cerebral haemodynamic testing using transcranial Doppler, Diagnostic Test: Ankle-brachial pressure index, Diagnostic Test: Six-minute walk testIndividuals 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 | – | Diagnostic Test: Cerebral haemodynamic testing using transcranial Doppler, Diagnostic Test: Ankle-brachial pressure index, Diagnostic Test: Six-minute walk testAge- and sex-matched cohort of individuals without peripheral arterial disease. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A cohort of individuals with symptomatic peripheral arterial disease (intermittent claudication) with an age- and sex-matched healthy control cohort.
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (10 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral haemodynamic testing using transcranial DopplerMeasurement 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 test | Healthy controls, Individuals with symptomatic peripheral arterial disease |
| Ankle-brachial pressure indexRatio of ankle to brachial blood pressure measured using handheld Doppler at rest and after exercise (six-minute walk test). | Diagnostic test | Healthy controls, Individuals with symptomatic peripheral arterial disease |
| Six-minute walk testSupervised 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). | Diagnostic test | Healthy controls, Individuals with symptomatic peripheral arterial disease |
Primary outcome
Peak % change of CBv from baseline
Time frame: Baseline
Change in response to performance of the ACE-III Cognitive Examination and Digit Span forward and backward.
3 secondary outcomes
Autoregulation index (Tieck's model)
Time frame: Baseline
Absolute score achieved on the Addenboook's cognitive examination (III)
Time frame: Baseline
Digit span forward and backward scores
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 42809627Cheshire BL, Sensier YJ, Beishon LC, Panerai RB, Sayers RD, Houghton JSM. Cognitive impairment and cerebral hemodynamics in individuals with symptomatic peripheral artery disease. Am J Physiol Heart Circ Physiol. 2026 Nov 1;331(5):H2004-H2013. doi: 10.1152/ajpheart.00634.2026. Epub 2026 Sep 29.
- Individual participant dataSharing planned: Yes. Fully-anonymised electronic data will be stored in the Cerebral Haemodynamics in ageing and Stroke Medicine research database for 25 years and will be made available via the University of Leicester data repository (https://leicester.figshare.com/) for a minimum of 10 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob D Sayers, MD principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Cognitive Impairment, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John SM Houghton (+44 (0)116 2502645, jsmh2@le.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak % change of CBv from baseline (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06369402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.