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Application of Digital Twins' Technology in Patients Who Had a Stroke, With Moyamoya Disease and With Cerebral Amyloid Angiopathy (CAA) During the Secondary Prevention Phase: A Proof of Concept Using a Randomized Control Trial (Clinical Study 6, STRATIF-AI Project)

RecruitingNAAges 18 Years - anyAllFondazione I.R.C.C.S. Istituto Neurologico Carlo …
NCT06714097 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to obtain initial feedback on the implementation of the STRATIF-AI platform and digital twin in the secondary prevention phase in patients with stroke, Moyamoya disease and Cerebral amyloid angiopathy, including adults of both sexes. The main questions it aims to answer is: how is the patients' experience regarding the use of the STRATIF-AI platform? Researchers will compare Arm 1, who use the STRATIF-AI app in addition to standard secondary prevention, against Arm 2, who receive standard secondary prevention only, to collect feedback regarding the platform usability. Participants in the Arm 1 will: * Complete cognitive and psychological assessments at the time of the first visit and after six months * Follow the indications received from the clinician for standard secondary prevention * Use the STRATIF-AI app daily for health management * Optionally

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📋 Eligibility rules (as published)
Inclusion Criteria: * People aged ≥ 18 * Clinical and neuroradiological diagnosis of stroke (TAC or MR); diagnosis of CAA based on Boston 2.0 criteria; diagnosis of Moyamoya disease based on diagnostic criteria 2021. * MOCA total score ≥ 23 * modified Rankin Scale (mRS) ≤ 2 * First-time patients at the Besta Institute * Ability to sign informed consent * Possibility of performing a brain MRI Exclusion Criteria: * Patients with transient neurological deficits that resolve within an hour and normal brain imaging * Patient under legal protection or deprived of liberty by judicial or administrative decision * Patient whose follow-up will be impossible * Contraindication to magnetic resonance imaging and/or Digital subtraction angiography (DSA) * Pregnant patients * Known or suspected drug or alcohol abuse
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What it tests

  • AI
  • healthy dialogue
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Where

1 site
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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