Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT06369402
Eligibility 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
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06369402
Study Brief:
Protocol Section:
NCT06369402