Telemedicine-supported Management for Acute Ischemic Stroke

NCT ID: NCT07302971

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-12-31

Brief Summary

Telemedicine-supported stroke care can provide standardized guidance to hospitals and regions with limited medical resources, thereby improving treatment outcomes for stroke patients in these areas. While this approach has been widely adopted in many developed countries, its efficacy in guiding basic-level hospitals to manage acute ischemic stroke requires further investigation through large-scale, high-quality studies.

This study focused on patients with acute ischemic stroke who sought treatment at basic-level hospitals, aiming to investigate the efficacy and safety of treating acute ischemic stroke with telemedicine-supported management. Hospitals assigned to the experimental group received remote consultation guidance, quality control and professional training from expert teams at leading stroke centers, China National Center for Neurological Disorders. Hospitals in the control group did not receive telemedicine-supported management.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telemedicine-Supported Group

Receive remote guidance from expert stroke centers for treatment of patients with intravenous thrombolysis, along with quality control for standardized workflow support, and professional training.

Group Type: EXPERIMENTAL

Telemedicine-Supported Management

Intervention Type: OTHER

Receive round-the-clock 7×24h remote consultation guidance from expert teams at leading stroke centers, covering patient triage and initial assessment, thrombolysis decision-making, and treatment guidance. Undergo quality control for standardized workflow implementation, and professional training.

Standard Treatment Group without Telemedicine-Supported Management

Control-group patients will receive routine stroke care at their primary care hospitals, with no remote consultation, study-related quality control, or extra training. Care will follow the hospitals' usual protocols, including emergency assessment, neurological evaluation, imaging, and intravenous thrombolysis. Hospitals may continue their regular stroke-related training during the study to reflect real-world practice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telemedicine-Supported Management

Receive round-the-clock 7×24h remote consultation guidance from expert teams at leading stroke centers, covering patient triage and initial assessment, thrombolysis decision-making, and treatment guidance. Undergo quality control for standardized workflow implementation, and professional training.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Basic-level hospitals in China (Definition: Hospitals classified as secondary-level (Grade II) or below under China's Hospital Grading Management Standards, or hospitals located in counties/county-level cities).

2. Equipped with an emergency department and neurology ward capable of admitting stroke patients.

3. Equipped with CT and/or MRI capable of diagnosing AIS.

4. Equipped with intravenous thrombolytic drugs for acute ischemic stroke.

1. Age ≥ 18 years.

2. Diagnosed with acute ischemic stroke.

3. CT/MRI confirms absence of intracerebral hemorrhage.

4. Onset of stroke symptoms ≤ 4.5 hours.

5. pre-stroke mRS score ≤1.

6. Informed consent obtained from patient or their legal representative.

Exclusion Criteria

1. Admitting fewer than 10 patients with acute ischemic stroke per month.

2. Currently participating in other clinical trials that may interfere with this trial.

1. Presence of contraindications for intravenous thrombolysis according to AHA/ASA guidelines

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Professor of Neurology, Xuanwu Hospital, Capital Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Xunming Ji

Role: CONTACT

Phone: 01083198962

Email: jixm@ccmu.edu.cn

Chuanjie Wu

Role: CONTACT

Phone: 01083199439

Email: wuchuanjie@ccmu.edu.cn

Other Identifiers

TOGETHER

Identifier Type: -

Identifier Source: org_study_id