Remote telemedicine support for acute ischemic stroke care at smaller hospitals

Telemedicine-supported Management of Acute Ischemic Stroke in the Basic-level Hospitals

This project will try remote telemedicine support to help adults who arrive within 4.5 hours of an acute ischemic stroke get faster, standardized care at smaller hospitals.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 2400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Capital Medical University (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07302971 on ClinicalTrials.gov

What this trial studies

This interventional program compares basic-level hospitals that receive remote consultation, quality control, and professional training from expert stroke centers with hospitals that do not receive those services. It focuses on adult patients with acute ischemic stroke who present within 4.5 hours and have CT/MRI confirmation that excludes intracerebral hemorrhage, with pre-stroke mRS ≤1. The telemedicine intervention includes real-time remote consultation, treatment guidance, and local staff training delivered by expert teams affiliated with national stroke centers and Capital Medical University. Outcomes focus on treatment delivery (for example timeliness and use of thrombolysis) and patient safety to determine whether telemedicine improves care in these settings.

Who should consider this trial

Good fit: Adults (≥18) with acute ischemic stroke presenting to participating basic-level hospitals within 4.5 hours of symptom onset, with CT/MRI excluding hemorrhage and pre-stroke mRS ≤1, who can provide informed consent (or whose representative can).

Not a fit: Patients who arrive after 4.5 hours, have intracerebral hemorrhage, have significant pre-stroke disability (mRS >1), or present to nonparticipating hospitals are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could increase timely thrombolysis and improve outcomes for stroke patients treated at smaller hospitals.

How similar studies have performed: Telestroke programs in many developed countries have shown increased thrombolysis rates and faster treatment times, but large-scale evidence specifically in China's basic-level hospitals remains limited.

Eligibility criteria

Inclusion Criteria:

* Hospital 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.
* Patient Inclusion Criteria:

  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:

* Hospital 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.
* Patient Exclusion Criteria:

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

Where this trial is running

Beijing, Beijing Municipality

• Xuanwu Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Xunming Ji

Conditions: Acute Ischemic Stroke