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

Not Applicable

Recruiting

• Conditions: Ischemic Stroke At a Young Age; Secondary Prevention

• Registration Number: NCT06820411
• Lead Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-20
• Status Verified: 2025-02
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of the Young Stroke Clinic Lifestyle Intervention	From baseline to study completion (12 months)	The primary outcome assesses the feasibility of the intervention based on four key metrics: * Eligibility Rate: Proportion of eligible participants among all screened young stroke patients.; * Consent Rate: Proportion of eligible patients who agree to participate.; * Adherence Rate: Degree of compliance with lifestyle recommendations, assessed through validated scoring tools.; * Dropout Rate: Proportion of participants who discontinue before study completion.; These measures will determine whether the intervention is practical and acceptable for future large-scale trials.

Secondary Outcome Measures

Name	Time	Method
Impact of the Young Stroke Clinic Intervention on Cardiovascular Health and Lifestyle Factors	Baseline, 3 months, and 6 months	The study evaluates the effect of the intervention on cardiovascular health and lifestyle modifications. Key measures include: * Cardiovascular Health Score (LE8): Comparison at baseline, 3 months, and 6 months.; * Major Adverse Cardiovascular Events (MACE): Incidence of recurrent stroke, myocardial infarction, or cardiovascular death.; * Physical Activity, Sleep, and Smoking Behavior: Assessed through validated questionnaires (International Physical Activity Questionnaire, Pittsburgh Sleep -Quality Index, 14-MEDAS, and daily cigarette count).; * Wearable Device Metrics: Heart rate variability, resting heart rate, and sleep duration.; * Inflammatory Biomarkers: Serum levels of TNF-alpha, IL-6, IL-10, and other cytokines.

Trial Locations

Locations (1)

IRCCS National Neurological Institute "C. Mondino" Foundation, Pavia, Pavia 27100; 🇮🇹 Pavia, PV, Italy