Clinical trial NCT06820411: A Pilot Study to Assess Optimal Prevention and Outcome Improvement in Young Ischemic Stroke
Official title: Y-SCOPE Study: a Pilot Study to Assess Optimal Prevention and Outcome Improvement in Young Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke At a Young Age
Secondary Prevention
Keywords: Young stroke prevention
Ischemic Stroke in Young Adults
Secondary Stroke Prevention
Lifestyle Modification After Stroke
Wearable Health Monitoring in Stroke
Stroke Risk Factor Management
Pilot Study in Stroke Prevention
Lead sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Feasibility of the Young Stroke Clinic Lifestyle Intervention
timeFrame: From baseline to study completion (12 months)
Secondary outcomes:
measure: Impact of the Young Stroke Clinic Intervention on Cardiovascular Health and Lifestyle Factors
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS National Neurological Institute "C. Mondino" Foundation, Pavia, Pavia 27100
state: PV
Study officials:
References: