Purpose The Y-SCOPE study aims to improve the health and recovery of young adults aged 18
to 65 who have experienced an ischemic stroke or a high-risk transient ischemic attack
(TIA). By focusing on personalized care and lifestyle changes, the study seeks to reduce
the chances of another stroke and promote better long-term health.
Background While strokes are often associated with older adults, recent studies have
shown an increase in ischemic strokes among younger individuals. Given that younger
patients are typically in their working years and have longer life expectancies, a stroke
can lead to significant long-term disability and economic challenges. Addressing the
unique needs of this population is crucial for effective care and research.
Study Design
This is an open-label pilot study, meaning both participants and researchers know which
treatments are being administered. The study will enroll 36 participants who will be
randomly assigned in a 2:1 ratio:
Intervention Group (24 participants): Will receive personalized care through a dedicated
"Young Stroke Clinic." Control Group (12 participants): Will receive standard post-stroke
care.
Intervention Details
Participants in the intervention group will:
Attend specialized clinic visits focused on young stroke patients.
Receive intensive counseling to manage risk factors such as high blood pressure,
cholesterol, and lifestyle habits.
Be provided with a wearable device (Whoop 4.0) to monitor health metrics like heart
rate, sleep patterns, and physical activity.
Duration The study will last for 12 months, with an 8-month enrollment period and a
minimum follow-up of 6 months for each participant.
Eligibility Criteria
Inclusion:
Ages 18 to 65.
Diagnosed with acute ischemic stroke or high-risk TIA.
Moderate to low cardiovascular health status.
Able to perform daily activities independently or with minimal assistance.
Exclusion:
Objectives
Primary Objective: Assess the feasibility of the study by evaluating participant
eligibility, consent rates, adherence to interventions, and retention rates.
Secondary Objectives: Compare health outcomes between the intervention and control
groups, including:
Improvement in cardiovascular health scores. Reduction in major cardiovascular events.
Enhancements in physical activity, diet, sleep quality, and smoking cessation. Changes in
inflammatory markers in the blood.
Potential Benefits While this is a pilot study and may not provide definitive evidence of
effectiveness, it aims to develop a tailored secondary prevention strategy for young
stroke patients. The personalized approach could lead to better management of risk
factors, improved quality of life, and a reduction in recurrent strokes and other
cardiovascular events.
Participation Participants will be required to attend scheduled clinic visits, engage in
counseling sessions, and use the provided wearable device consistently. Regular
monitoring and feedback will be integral parts of the program.
Confidentiality All personal health information and data collected during the study will
be kept confidential and used solely for research purposes.
This study is conducted by the Neurology Department and Stroke Unit at the IRCCS Mondino
Foundation.