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

NCT ID: NCT06820411

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2026-01-31

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.

Conditions

Ischemic Stroke At a Young Age; Secondary Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Young Stroke Clinic Intervention

Participants in this arm will receive specialized care at the Young Stroke Clinic, designed for individuals aged 18-65 who have experienced an ischemic stroke or high-risk TIA. The intervention includes:

Personalized risk factor management, focusing on blood pressure, cholesterol, smoking cessation, diet, and physical activity.

Intensive lifestyle counseling to encourage adherence to secondary prevention strategies.

Use of a wearable device (Whoop 4.0) to monitor heart rate variability, sleep patterns, and physical activity.

Regular follow-up visits with neurologists to track progress and provide guidance.

The goal is to optimize cardiovascular health, reduce recurrent stroke risk, and enhance long-term outcomes.

Group Type: EXPERIMENTAL

Young Stroke Clinic Lifestyle Intervention

Intervention Type: BEHAVIORAL

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.

Standard Post-Stroke Care

Intervention Type: OTHER

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.

Standard Care Control Group

Participants in this arm will receive standard post-stroke care based on current clinical guidelines. This includes:

Routine follow-up visits with healthcare providers. Medical management of stroke risk factors such as hypertension, diabetes, and dyslipidemia.

General lifestyle recommendations, including advice on diet, physical activity, and smoking cessation, as provided in standard clinical practice.

Unlike the experimental group, this arm does not include structured intensive lifestyle counseling, dedicated stroke clinic follow-ups, or wearable device monitoring.

Group Type: ACTIVE_COMPARATOR

Standard Post-Stroke Care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS National Neurological Institute "C. Mondino" Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS National Neurological Institute "C. Mondino" Foundation, Pavia, Pavia 27100

Pavia, PV, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Nicola Davide Loizzo, MD

Role: CONTACT

nicola.loizzo@mondino.it

0039 0382501460

Facility Contacts

Nicola Davide Loizzo, MD

Role: primary

nicola.loizzo@mondino.it

0039 0382501460

Federico Mazzacane, MD

Role: backup

Nicola Davide Loizzo, MD

Role: backup

Federica Ferrari, MD

Role: backup

Beatrice Del Bello, MD

Role: backup

Other Identifiers

Neuro Virtual Hospital

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Y-SCOPE Study

Identifier Type: -

Identifier Source: org_study_id