Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack With an Intelligent Management System (SPIRIT)

January 20, 2026 updated by: Zi-Xiao Li, Beijing Tiantan Hospital

Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack With an Intelligent System

The purpose of this study is to develop a digital health-based intelligent management system for the secondary prevention of ischemic stroke and to evaluate its effectiveness through a multicenter randomized controlled trial, assessing its health economic value.

Participants will receive usual care after discharge (control group) or be managed with a WeChat-based intelligent management system after discharge (intervention group).

At one year, all patients will undergo face-to-face follow-up to assess clinical events, medication adherence, and the achievement of target risk factor levels.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Before discharge, patients receive standard education on the secondary prevention of ischemic stroke from their physician, covering topics such as secondary prevention medications, risk factor management, lifestyle modifications, and rehabilitation. Additionally, the "Intelligent Management System," a WeChat-based applet, is activated for each patient. The system records basic patient information and integrates with mobile IoT devices, such as blood pressure monitors and glucose meters, allowing for self-monitoring of risk factors post-discharge. Based on international guidelines, high-level evidence, and the expertise of stroke specialists, a comprehensive clinical decision-making tree is established. This serves as the foundation for an AI feedback system that provides intelligent feedback on risk factor control and predicts recurrence risk. The patient interface includes educational content on ischemic stroke, risk factor management, lifestyle adjustments, and follow-up schedules post-discharge.

The system also features a physician interface, which enables attending doctors to offer online consultations, schedule face-to-face follow-up appointments, and manage patients long-term. Each patient is assigned to an "Online Stroke Care Team," which includes a "Health Management Officer" responsible for facilitating communication between the patient and the physician and providing basic health guidance. Additionally, an "Online Doctor" is available to answer stroke-related medical questions.

The Health Management Officer monitors patients' health data and arranges online or in-person consultations for those with poor adherence or suboptimal target achievement. Patient management is guided by the theory of health empowerment, creating an integrated online and offline ischemic stroke management intervention model.

Study Type

Interventional

Enrollment (Estimated)

4490

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Active, not recruiting
        • Beijing Tsinghua Changgung Hospital
    • Xinjiang
      • Shihezi, Xinjiang, China
        • Active, not recruiting
        • The First Affiliated Hospital of Shihezi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Patients diagnosed with acute ischemic stroke or transient ischemic attack.
  3. Time from onset to enrollment ≤ 14 days.
  4. Presence of at least one modifiable risk factor (hypertension, diabetes).
  5. Ability to independently use a smartphone to complete system tasks upon discharge, or with the assistance of family members.
  6. Signed informed consent by the patient or their family members.

Exclusion Criteria:

  1. Patients already enrolled in other stroke-related healthcare quality improvement projects or clinical trials.
  2. Patients or family members who refuse to sign the informed consent form.
  3. Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Behavioral: Cerebrovascular Disease Secondary Prevention Smart Management System
The continuous post-discharge intervention for patients was conducted using the Cerebrovascular Disease Secondary Prevention Smart Management System. This system, integrated with a WeChat-based applet, records patients' basic information and connects with mobile IoT devices such as blood pressure monitors and glucose meters. This allows patients to self-monitor their risk factors post-discharge. Based on international guidelines, high-level evidence, and the clinical expertise of cerebrovascular specialists, a comprehensive clinical decision-making tree was developed. This serves as the foundation for an AI feedback system that provides intelligent feedback on risk factor control and predicts the risk of recurrence.
No Intervention: Control group
Patients in the control group received secondary stroke prevention discharge recommendations from their attending physicians, based on standard medical practice. No additional interventions for secondary prevention were applied throughout the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular events and all-causes death
Time Frame: From enrollment to 1 year follow-up
Vascular and all-cause mortality events were collected for one year post-enrollment through face-to-face follow-ups and patient self-reports. Vascular events included stroke recurrence, transient ischemic attacks, myocardial infarction, vascular interventions or surgeries, and systemic embolism. If a patient experienced both a vascular event and death, only one event was recorded. In cases of multiple vascular events, only the first event was documented.
From enrollment to 1 year follow-up
Risk factor control rate
Time Frame: From enrollment to 1 year follow-up
Risk factor control was defined as achieving glycated hemoglobin (HbA1c) ≤7% or blood pressure below the target set at discharge. If a patient had both hypertension and diabetes at enrollment, meeting the criteria for both conditions was considered two achieved targets. If the patient had only hypertension or diabetes at enrollment, meeting the target for the respective condition was considered one achieved target.
From enrollment to 1 year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission to hospital within 1 year
Time Frame: From enrollment to 1 year follow-up
From enrollment to 1 year follow-up
Stroke-related readmission
Time Frame: From enrollment to 1 year follow-up
From enrollment to 1 year follow-up
Direct medical costs
Time Frame: From enrollment to 1 year follow-up
From enrollment to 1 year follow-up
Rate of good adherence to secondary prevention medicine
Time Frame: From enrollment to 1 year follow-up
From enrollment to 1 year follow-up
Adverse drug reaction
Time Frame: From enrollment to 1 year follow-up
From enrollment to 1 year follow-up
Body mass index
Time Frame: From enrollment to 1 year follow-up
From enrollment to 1 year follow-up
Waist circumstance
Time Frame: From enrollment to 1 year follow-up
From enrollment to 1 year follow-up
Frequency of blood pressure monitoring
Time Frame: From enrollment to 1 year follow-up
calculated as time/week
From enrollment to 1 year follow-up
Frequency of blood glucose monitoring
Time Frame: From enrollment to 1 year follow-up
calculated as time/week
From enrollment to 1 year follow-up
Blood lipid levels
Time Frame: From enrollment to 1 year follow-up
Included total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceridee
From enrollment to 1 year follow-up
Rehabilitation
Time Frame: From enrollment to 1 year follow-up
From enrollment to 1 year follow-up
Smoking
Time Frame: From enrollment to 1 year follow-up
From enrollment to 1 year follow-up
Alcohol
Time Frame: From enrollment to 1 year follow-up
From enrollment to 1 year follow-up
Regular exercise
Time Frame: From enrollment to 1 year follow-up
From enrollment to 1 year follow-up
Overall physical activity level
Time Frame: From enrollment to 1 year follow-up
Assessed by IPAQ-S, calculated as MET-min/week
From enrollment to 1 year follow-up
Fatigue
Time Frame: From enrollment to 1 year follow-up
Assessed by Fatigue Severity Scale (FSS). Fatigue was defined as total FSS score ≥36
From enrollment to 1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Collaborators

Beijing Tsinghua Chang Gung Hospital
The First Hospital of Jilin University
First People's Hospital of Foshan
The Second Affiliated Hospital of Fujian Medical University
The affiliated Hospital of Shihezi University
Xiangya Hospital of Zhongnan University
BOE Technology Group Co. Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022YFC250494

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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