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:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT05967728
Eligibility Criteria:
Inclusion Criteria:
* For patients with Cerebral Small Vessel Disease (CSVD):
1. Age ≥18 years
2. Evidence of CSVD, defined as (a) beginning confluent white-matter changes (Age-Related White Matter Changes grade 2) on any slice on CT/MRI Brain(21) OR (b) ≥2 supratentorial subcortical infarcts
3. Either (a) cognitive complaints from the patient or family member OR (b) history of small vessel ischemic stroke with corresponding evidence of brain infarct on CT or MRI that is attributed by the treating physician to CSVD
* For patients with ischemic stroke:
1. Age ≥18 years
2. Evaluated in the Mobile Stroke Unit
3. Diagnosed as having an acute ischemic stroke (all MSU code stroke activations during the study will be tracked)
Exclusion Criteria:
* For patients with CSVD:
1. Unable to converse meaningfully (severe dementia or post-stroke deficit)
2. No phone access for study monitoring and follow-up (either cell or landline)
3. Therapeutic anticoagulation or other bleeding diathesis posing an unacceptable risk in physician's opinion (antiplatelet therapy is permitted)
4. Any vascular, soft-tissue, or orthopedic injury that in the physician's opinion contraindicates arm ischemic preconditioning
5. History of peripheral vascular disease, such as subclavian or other upper limb arterial stenosis or occlusion
* For patients with ischemic stroke:
1. Unable to give consent or assent by proxy (written or recorded by MSU audio-video)
2. Therapeutic anticoagulation or other bleeding diathesis as with CSVD above
3. Any vascular, soft-tissue, or orthopedic injury that in the physician's opinion contraindicates arm ischemic preconditioning
4. History of peripheral vascular disease, such as subclavian or other upper limb arterial stenosis or occlusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT05967728
Study Brief:
Protocol Section:
NCT05967728