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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)

Study acronym: SMART
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Apr 2027 → Oct 2027
See other at-risk trials from Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Record History

  1. Start date: Apr 2026 to Oct 2026
    • Primary and study completion pushed from Apr 2027 to Oct 2027
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    • Publications: details revised at 4 of 4 entries
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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, purchase wearable devices that connect to the app. * Participate in interviews at the six-month mark to share their experiences with the app. Patients in the Arm 2 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
Trial Details
NCT Number NCT06714097
Lead Sponsor Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Conditions
(from sponsor)		 Stroke, Moyamoya Disease, Cerebral Amyloid Angiopathy
Related terms Cerebral Amyloid Angiopathy, Moyamoya Disease, Stroke
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov