Improving treatment quality for ischemic stroke using advanced technology

The Improve Acute Reperfusion Treatment Quality for Ischemic Stroke Through Spatiotemporal Computing in China (IMPROVE-II ) -A Multicenter, Evaluator-Blind, Cluster-Randomized Controlled Study

This study is testing a new way to improve treatment for people having an ischemic stroke by using smart technology to speed up and enhance the effectiveness of their care in hospitals.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06330051 on ClinicalTrials.gov

What this trial studies

This study aims to enhance the quality of acute ischemic stroke (AIS) treatment by implementing a goal-oriented integrated intervention model known as the FAST model, which utilizes spatiotemporal computing and intelligent bracelet positioning. The study will involve a multicenter, evaluator-blind, cluster-randomized controlled design across 20 secondary or tertiary hospitals in the Beijing-Tianjin-Hebei-Shanxi-Neimenggu region. The intervention group will use a real-time data feedback system to improve the speed and effectiveness of intravenous thrombolysis for AIS patients. The study will assess the validity and safety of this approach over a four-month intervention period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who present with acute ischemic stroke within 4.5 hours of symptom onset.

Not a fit: Patients who do not present with acute ischemic stroke or who arrive at the hospital after the 4.5-hour window may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the time to reperfusion therapy for ischemic stroke patients, potentially improving outcomes.

How similar studies have performed: Other studies utilizing technology to improve stroke treatment have shown promise, indicating that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

Hospitals#

1. Secondary or tertiary public hospitals with an emergency department that receive patients with AIS.
2. Admit at least 50 patients of AIS within 4.5 hours after onset each month.
3. Have the capacity of intravenous thrombolytic therapy or/and endovascular treatment.
4. Voluntarily participate in this research and cooperate with the installation of bluetooth positioning device and the improvement of AIS emergency procedures.
5. Have good cooperation relationship among the department of Neurology, Emergency, Interventional department, Neurosurgery department, Laboratory department and Radiology department.
6. Have ability to establish or participate in the establishment of patient information database and arrange a person responsible for the collection of case information.

Patients# Patients who are ≥18 years old are eligible for inclusion if they present with AIS diagnosed by CT and/or MRI, arrive at hospital within 4.5 hours after symptom onset, sign the informed consent form and agree to follow up until 3 months after stroke onset.

Exclusion Criteria:

Hospitals#

1. Hospital that unable to cooperate and complete the research.
2. Hospitals that are participating in other AIS medical quality improvement projects or related clinical trials.

Patients#

1. Patients refuse to sign informed consent and follow up until 3 months after stroke onset.
2. Patients with mild nondisabling stroke symptoms (Defined as NIHSS≤3, as any of the following: isolated facial paralysis; mild cortical blindness; mild hemianesthesia; mild hemiataxia.)
3. Life expectancy three-months or less by judgment of the investigator.
4. Participation in any interventional study that may affect the outcome

Where this trial is running

Tianjin, Tianjin Municipality

• WuQing People's Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Zixiao Li, MD

Conditions Acute Ischemic Stroke; ischemic stroke; intravenous thrombolysis; endovascular treatment; medical quality; spatiotemporal computing