Investigating brain blood flow and memory issues in people with leg artery disease
Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease
This study is testing if changes in blood flow to the brain are linked to memory problems in older adults with leg artery disease compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT06369402 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between peripheral arterial disease (PAD) and cognitive impairment in older adults. It will involve 20 individuals diagnosed with symptomatic PAD and 20 healthy controls, who will undergo non-invasive assessments including ankle blood pressure measurements and cerebral blood flow evaluations using ultrasound. Participants will also perform memory and thinking tests to assess cognitive function. The study seeks to determine if altered brain blood flow contributes to cognitive issues in those with PAD.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with a clinical diagnosis of symptomatic peripheral arterial disease.
Not a fit: Patients under 50 years of age or those with major co-morbidities affecting cerebral autoregulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of cognitive impairment in patients with peripheral arterial disease.
How similar studies have performed: While studies have explored cognitive impairment in vascular diseases, this specific investigation into the relationship between PAD and cerebral hemodynamics is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leicester, Leicestershire
- Glenfield Hospital Leicester — Leicester, Leicestershire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Rob D Sayers, MD — University of Leicester
- Study coordinator: John SM Houghton
- Email: jsmh2@le.ac.uk
- Phone: +44 (0)116 2502645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.