Ischemic Stroke at a Young AgeY-SCOPENCT06820411
A Pilot Study to Assess Optimal Prevention and Outcome Improvement in Young Ischemic Stroke
A study testing Young Stroke Clinic Lifestyle Intervention and Standard Post-Stroke Care in people with Ischemic Stroke at a Young Age and Secondary Prevention, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ischemic Stroke at a Young Age, Secondary Prevention
- What is being tested?
- Young Stroke Clinic Lifestyle Intervention and Standard Post-Stroke Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS National Neurological Institute "C. Mondino" Foundation, Pavia, Pavia 27100
Pavia, PV, 27100
About this study
Official title: Y-SCOPE Study: A Pilot Study to Assess Optimal Prevention and Outcome Improvement in Young Ischemic Stroke
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.
Read more
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.
- Being tested
- Young Stroke Clinic Lifestyle Intervention, Standard Post-Stroke Care
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Young Stroke Clinic Lifestyle InterventionBehavioural
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Young Stroke Clinic Intervention | Experimental | 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. |
| Standard Care Control Group | Active comparator | 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. Receives: Other: Standard Post-Stroke Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Young Stroke Clinic Lifestyle Intervention
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.
Measured: From baseline to study completion (12 months)
Secondary outcomes (1)
Impact of the Young Stroke Clinic Intervention on Cardiovascular Health and Lifestyle Factors
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.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start20 Jan 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke at a Young AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820411
- Sponsor's protocol ID
- Y-SCOPE Study
- Other IDs
- Neuro Virtual Hospital
- Acronym
- Y-SCOPE
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Y-SCOPE Study: A Pilot Study to Assess Optimal Prevention and Outcome Improvement in Young Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06820411
- Acronym / sponsor ID
- Y-SCOPE / Y-SCOPE Study
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young Stroke Clinic Intervention | Experimental | –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. |
| Standard Care Control Group | Active comparator | Other: Standard Post-Stroke CareParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Young Stroke Clinic Lifestyle InterventionThe 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. | Behavioural | – |
| Standard Post-Stroke CareThe 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. | Other | Standard Care Control Group |
Primary outcome
Feasibility of the Young Stroke Clinic Lifestyle Intervention
Time frame: 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.
1 secondary outcome
Impact of the Young Stroke Clinic Intervention on Cardiovascular Health and Lifestyle Factors
Time frame: Baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Young Stroke Clinic Lifestyle Intervention and Standard Post-Stroke Care in people with Ischemic Stroke at a Young Age and Secondary Prevention, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Young Stroke Clinic Lifestyle Intervention (time frame: From baseline to study completion (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.