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

ConditionsIschemic Stroke Transient Ischemic Attack (TIA)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Patients diagnosed with acute ischemic stroke or transient ischemic attack.

Time from onset to enrollment ≤ 14 days.

Presence of at least one modifiable risk factor (hypertension, diabetes).

Disqualifiers

Patients already enrolled in other stroke-related healthcare quality improvement projects or clinical trials.

Patients or family members who refuse to sign the informed consent form.

Pregnant or breastfeeding women.

Trial design

Design model

Parallel

Treatments tested in this trial

Cerebrovascular Disease Secondary Prevention Smart Management System
Behavioral
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.

Treatment groups

4,490 Participants

are divided into 2 treatment groups

Group A: Control groupNo intervention 0 interventions

Group B: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Vascular events and all-causes death

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.

Time frame