Acute Ischemic StrokeIMPROVE-IINCT06330051
The Improve Acute Reperfusion Treatment Quality for Ischemic Stroke Through Spatiotemporal Computing Thecnology in China
A study testing The goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model) in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This study intends to construct the goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model) to promote the reconstruction of workflow in stroke centers and to shorten in-hospital delay of reperfusion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- The goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,219 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2024to 13 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitals#
- Secondary or tertiary public hospitals with an emergency department that receive patients with AIS.
- Admit at least 50 patients of AIS within 4.5 hours after onset each month.
- Have the capacity of intravenous thrombolytic therapy or/and endovascular treatment.
- Voluntarily participate in this research and cooperate with the installation of bluetooth positioning device and the improvement of AIS emergency procedures.
- Have good cooperation relationship among the department of Neurology, Emergency, Interventional department, Neurosurgery department, Laboratory department and Radiology department.
- 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.
Who cannot join
- Hospitals#
- Hospital that unable to cooperate and complete the research.
- Hospitals that are participating in other AIS medical quality improvement projects or related clinical trials.
- Patients#
- Patients refuse to sign informed consent and follow up until 3 months after stroke onset.
- Patients with mild nondisabling stroke (Defined as no measurable neurologic deficit, or NIHSS≤3 with only one of the following isolated symptoms: isolated facial paralysis; mild cortical blindness; mild hemianesthesia; mild hemiataxia.)
- Life expectancy three-months or less by judgment of the investigator.
- Participation in any interventional study that may affect the outcome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Improve Acute Reperfusion Treatment Quality for Ischemic Stroke Through Spatiotemporal Computing Technology in China (IMPROVE-II ) -A Multicenter Cluster-Randomized Controlled Study
This study intends to construct the goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model) to promote the reconstruction of workflow in stroke centers and to shorten in-hospital delay of reperfusion treatment for AIS patients. This is a multicenter, cluster-randomized controlled study aims to verify the efficacy and safety of the FAST model.
Read the detailed description
This study intends to construct the goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model). Then a multicenter, cluster-randomized controlled study aims to verify the efficacy and safety of this FAST model.
This study will recruit 20 secondary or tertiary hospitals that meet the inclusion criteria, mainly distributed in the Beijing-Tianjin-Hebei-Shanxi-Neimenggu region. After 3 months of baseline information collection, 20 hospitals will be randomly assigned to the control and intervention groups. Then, the intervention group will install ithe intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology for 4 months. As the knowledge gained from the training may affect the identification of AIS patients, the duration of the training will keep as short as possible. We will conduct training to ensure that only trained caregivers and researchers master the use of the application to maintain the integrity of the intervention. During this 4-month period, both the control group and the intervention group will cease data collection. The FAST model intervention based on spatiotemporal computing technology will uniformly start after installation and training in each intervention group hospital. The intervention group will receive the goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology for 8 months and collect information, mainly the critical time information of the AIS reperfusion therapy process. In the control group, only information will be collected.
We will compare the critical treatment time information, Door to Needle time and Door to Puncture time, etc., between the two groups and conduct a 3-month follow-up.
- Conditions
- Acute Ischemic Stroke
- Being tested
- The goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model)
- Keywords
- ischemic stroke, intravenous thrombolysis, endovascular treatment, medical quality, spatiotemporal computing
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model)Behavioural
Spatiotemporal computing technology: Spatiotemporal positioning devices are installed in the emergency environment of the intervention hospitals in advance. Duration at each node of AIS patients wearing an intelligent bracelet will be calculated and displayed via the "Green Fast" mobile application.
Time Target: According to the standardized procedure, we will preset the target times at the key nodes of reperfusion therapy workflow in the system in advance.
Alert: Reminders or alerts will be triggered if duration at the node exceeds predefined targets.
Feedback: The system is equipped with procedure feedback function to managers and users. The teams of intevention hospital will organize periodic regular meetings weekly and trial management group will participate in the meetings every two weeks. Using the data provided by the "Green Fast", problems existing in the treatment workflow will be identified and solved. A continuous PDCA cycle will be conducted for quality improvement.
| Study group | Role | What they receive |
|---|---|---|
| Improvement intervention | Experimental | receive the following continuous improvement intervention for 8months Receives: Behavioral: The goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model) |
| Control group | No intervention | Only information will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Door to Needle time (DNT) for intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Secondary outcomes (8)
The Door to Puncture time (DPT) for endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
The rate of intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
The rate of endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours of receiving reperfusion therapy.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Proportion of patients with 90-day favorable functional outcome.
mRS 0-1
Measured: Participants will be followed for 3 month after stroke onset.
Proportion of patients with 90-day independent functional outcome.
mRS 0-2
Measured: Participants will be followed for 3 month after stroke onset.
in-hospital mortality
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
90-day mortality
Measured: Participants will be followed for 3 month after stroke onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start18 Mar 2024
- Primary completion13 Oct 2025
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zi-Xiao Li, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330051
- Sponsor's protocol ID
- KY 2023-184-02
- Acronym
- IMPROVE-II
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improve Acute Reperfusion Treatment Quality for Ischemic Stroke Through Spatiotemporal Computing Technology in China (IMPROVE-II ) -A Multicenter Cluster-Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06330051
- Acronym / sponsor ID
- IMPROVE-II / KY 2023-184-02
- Conditions
- Acute Ischemic Stroke
- Keywords
- ischemic stroke, intravenous thrombolysis, endovascular treatment, medical quality, spatiotemporal computing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,219 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to construct the goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model) to promote the reconstruction of workflow in stroke centers and to shorten in-hospital delay of reperfusion treatment for AIS patients. This is a multicenter, cluster-randomized controlled study aims to verify the efficacy and safety of the FAST model.
Detailed description
This study intends to construct the goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model). Then a multicenter, cluster-randomized controlled study aims to verify the efficacy and safety of this FAST model.
This study will recruit 20 secondary or tertiary hospitals that meet the inclusion criteria, mainly distributed in the Beijing-Tianjin-Hebei-Shanxi-Neimenggu region. After 3 months of baseline information collection, 20 hospitals will be randomly assigned to the control and intervention groups. Then, the intervention group will install ithe intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology for 4 months. As the knowledge gained from the training may affect the identification of AIS patients, the duration of the training will keep as short as possible. We will conduct training to ensure that only trained caregivers and researchers master the use of the application to maintain the integrity of the intervention. During this 4-month period, both the control group and the intervention group will cease data collection. The FAST model intervention based on spatiotemporal computing technology will uniformly start after installation and training in each intervention group hospital. The intervention group will receive the goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology for 8 months and collect information, mainly the critical time information of the AIS reperfusion therapy process. In the control group, only information will be collected.
We will compare the critical treatment time information, Door to Needle time and Door to Puncture time, etc., between the two groups and conduct a 3-month follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Improvement intervention | Experimental | Behavioral: The goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model)receive the following continuous improvement intervention for 8months |
| Control group | No intervention | –Only information will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hospitals#
- Secondary or tertiary public hospitals with an emergency department that receive patients with AIS.
- Admit at least 50 patients of AIS within 4.5 hours after onset each month.
- Have the capacity of intravenous thrombolytic therapy or/and endovascular treatment.
- Voluntarily participate in this research and cooperate with the installation of bluetooth positioning device and the improvement of AIS emergency procedures.
Key exclusion criteria (8 listed)
- Hospitals#
- Hospital that unable to cooperate and complete the research.
- Hospitals that are participating in other AIS medical quality improvement projects or related clinical trials.
- Patients#
- Patients refuse to sign informed consent and follow up until 3 months after stroke onset.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model)Spatiotemporal computing technology: Spatiotemporal positioning devices are installed in the emergency environment of the intervention hospitals in advance. Duration at each node of AIS patients wearing an intelligent bracelet will be calculated and displayed via the "Green Fast" mobile application. Time Target: According to the standardized procedure, we will preset the target times at the key nodes of reperfusion therapy workflow in the system in advance. Alert: Reminders or alerts will be triggered if duration at the node exceeds predefined targets. Feedback: The system is equipped with procedure feedback function to managers and users. The teams of intevention hospital will organize periodic regular meetings weekly and trial management group will participate in the meetings every two weeks. Using the data provided by the "Green Fast", problems existing in the treatment workflow will be identified and solved. A continuous PDCA cycle will be conducted for quality improvement. | Behavioural | Improvement intervention |
Primary outcome
The Door to Needle time (DNT) for intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
8 secondary outcomes
The Door to Puncture time (DPT) for endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
The rate of intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
The rate of endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours of receiving reperfusion therapy.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Proportion of patients with 90-day favorable functional outcome.
Time frame: Participants will be followed for 3 month after stroke onset.
Proportion of patients with 90-day independent functional outcome.
Time frame: Participants will be followed for 3 month after stroke onset.
in-hospital mortality
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
90-day mortality
Time frame: Participants will be followed for 3 month after stroke onset.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model) in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Door to Needle time (DNT) for intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset. (time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.