A Pilot Study to Assess Optimal Prevention and Outcome Improvement in Young Ischemic Stroke

Summary

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:

* Pregnancy.
* Lack of access to a compatible smartphone for device monitoring.
* Inability to commit to the follow-up schedule.

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.

Conditions

• Ischemic Stroke at a Young Age
• Secondary Prevention

Interventions

BEHAVIORAL

Young Stroke Clinic Lifestyle Intervention

The Young Stroke Clinic Lifestyle Intervention is a structured program designed for young adults (18-65 years) recovering from ischemic stroke or high-risk TIA. It includes: * Personalized risk factor management targeting blood pressure, cholesterol, smoking cessation, and lifestyle habits. * Intensive lifestyle counseling to improve diet, physical activity, and overall cardiovascular health. * Wearable device monitoring (Whoop 4.0) to track heart rate variability, sleep patterns, and physical activity. * Regular follow-up visits at a dedicated stroke clinic with tailored guidance from neurologists.

OTHER

Standard Post-Stroke Care

The Standard Post-Stroke Care group will receive usual medical management based on current clinical guidelines for secondary stroke prevention. This includes: * Routine follow-up visits with healthcare providers. * Standard medical treatment for stroke risk factors (e.g., blood pressure, cholesterol, diabetes). * General lifestyle recommendations on diet, physical activity, and smoking cessation as part of routine clinical care.

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-20

Primary Completion

2026-10-31

Completion

2026-10-31

Countries

• Italy

Study Locations