Y-SCOPE Study: a Pilot Study to Assess Optimal Prevention and Outcome Improvement in Young Ischemic Stroke

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS National Neurological Institute C. Mondino Foundation, Pavia, Pavia 27100
RECRUITING
Pavia
Contact Information
Primary
Nicola Davide Loizzo, MD
nicola.loizzo@mondino.it
0039 0382501460
Time Frame
Start Date: 2025-01-20
Estimated Completion Date: 2026-01
Participants
Target number of participants: 36
Treatments
Experimental: 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.
Active_comparator: 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.
Sponsors
Leads: IRCCS National Neurological Institute C. Mondino Foundation

This content was sourced from clinicaltrials.gov