Improving prevention and outcomes for young adults after ischemic stroke
Y-SCOPE Study: a Pilot Study to Assess Optimal Prevention and Outcome Improvement in Young Ischemic Stroke
This study is testing whether a personalized lifestyle program can help young adults who have had an ischemic stroke recover better and reduce their risk of future strokes compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation Academic / other |
| Locations | 1 site (Pavia, PV) |
| Trial ID | NCT06820411 on ClinicalTrials.gov |
What this trial studies
The Y-SCOPE study aims to enhance recovery and health in young adults aged 18 to 65 who have suffered an ischemic stroke or high-risk transient ischemic attack (TIA). This open-label pilot study will enroll 36 participants, randomly assigning them to either a lifestyle intervention group or standard post-stroke care. The focus is on personalized care and lifestyle modifications to reduce the risk of subsequent strokes and promote long-term health. By addressing the unique needs of younger stroke patients, the study seeks to provide tailored interventions that can lead to better health outcomes.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 18 to 65 who have experienced an acute ischemic stroke or high-risk TIA and have a low to moderate cardiovascular health status.
Not a fit: Patients who are pregnant, have severe cognitive impairment, or are unable to use the required wearable device may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of recurrent strokes and improve the overall health and quality of life for young stroke survivors.
How similar studies have performed: While there is growing interest in addressing stroke prevention in younger populations, this specific approach focusing on lifestyle intervention and wearable health monitoring is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18 to 65 years. * Diagnosis: Acute ischemic stroke or high-risk transient ischemic attack (TIA) (ABCD2 score ≥ 6). * Cardiovascular Health Status: Low or moderate cardiovascular health, assessed by the American Heart Association's Life's Essential 8 (LE8) Score. * Functional Independence: Modified Rankin Scale (mRS) score of 0 to 2 at enrollment. * Ability to Participate: Participants must be able to adhere to the study's follow-up visits and intervention requirements. Exclusion Criteria: * Pregnancy. * Inability to Use Wearable Device: Participants must have a compatible smartphone for the wearable device (Whoop 4.0). * Medical Conditions: Any condition that prevents participation in the follow-up program (e.g., severe cognitive impairment, terminal illness). * Unwillingness to Participate: Individuals who decline consent or are unable to comply with study requirements.
Where this trial is running
Pavia, PV
- IRCCS National Neurological Institute "C. Mondino" Foundation, Pavia, Pavia 27100 — Pavia, Pv, Italy (Recruiting)
Study contacts
- Study coordinator: Nicola Davide Loizzo, MD
- Email: nicola.loizzo@mondino.it
- Phone: 0039 0382501460
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.