Ischemic StrokeNCT03578107
Improve Acute Reperfusion Treatment Quality for Stroke in China, IMPROVE: Stroke Care in China
A study testing improvement of quality of stroke care in people with Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
In order to bridge the great gaps, Chinese Stroke Association (CSA) and American Heart Association (AHA) sought to develop, conduct, and assess a multifaceted quality improvement intervention to increase the adherent rate of IV tPA and ET and improve 3-month clinical outcomes for these patients through our… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- improvement of quality of stroke care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,895 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Oct 2020
- 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：
- Voluntary.
- Hospitals from CSCA.
- Secondary or tertiary public hospitals with an emergency department and neurologic wards that receive patients with AIS.
- Have a 24*7 on-call stroke team.
- Have the capacity of IV rt-PA thrombolytic therapy or/and endovascular treatment.
Show all 11Show fewer
- Implement at least 10 patients' rt-PA or/and endovascular treatment during the last year.
- Admit at least 5 patients of acute ischemic stroke within 24 hours after onset each month.
- Have full desire to improve the procedure of treatment of acute ischemic stroke.
- Have good cooperation among Neurology department, Emergency department, Interventional department, Neurosurgery department, Laboratory and Radiology department.
- Patients： Patients who are ≥18 years old were eligible for inclusion if they presented with acute ischemic stroke diagnosed by CT and/or MRI and arrived at hospital within 6 hours after symptom onset.
Who cannot join
- Hospitals：
- Hospitals that can not comply with the protocol and finish the research.
- Grade-one hospitals and non cerebral vascular disease specialized hospitals.
- Hospitals involved in other stroke care quality improvement projects or relevant clinical trials.
- Patients：
- 1）Patients refuse to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
Official title: Improve Acute Reperfusion Treatment Quality for Stroke in China
In order to bridge the great gaps, Chinese Stroke Association (CSA) and American Heart Association (AHA) sought to develop, conduct, and assess a multifaceted quality improvement intervention to increase the adherent rate of IV tPA and ET and improve 3-month clinical outcomes for these patients through our cluster-randomized stepped-wedge IMPROVE: Stroke in China trial.
- Conditions
- Ischemic Stroke
- Being tested
- improvement of quality of stroke care
- Keywords
- acute ischemic stroke, IV-tPA, endovascular treatment, intervention
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
improvement of quality of stroke careBehavioural
- hospital tool kits for quality improvement of reperfusion therapy ;
- organizational stakeholder and opinion leader meetings;
- data monitoring and feedback reports；
- webinar for hospital teams
| Study group | Role | What they receive |
|---|---|---|
| Improvement intervention1 | Other | receive the following improvement intervention for 18 months： Receives: Behavioral: improvement of quality of stroke care |
| Improvement intervention2 | Other | receive the following improvement intervention for 12 months： Receives: Behavioral: improvement of quality of stroke care |
| Improvement intervention3 | Other | receive the following improvement intervention for 6 months： Receives: Behavioral: improvement of quality of stroke care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adherence rate of guidelines for IV-tPA and/or endovascular treatment in eligible patients.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (6)
proportional change of intravenous thrombolytic therapy in eligible patients 4.5h after the onset
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
proportional change of endovascular treatment in eligible patients 6h after the onset
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
time from arrival to hospitals to intravenous thrombolytic therapy
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
door-to-puncture time
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
in-hospital mortality
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
3-month disability（mRS≥3 ）
Measured: patients will be followed up at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Jul 2018
- Primary completion31 Jul 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- 15,895 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
- Investigators
- Yongjun Wang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578107
- Sponsor's protocol ID
- KY 2018-044-01
- Status last verified
- Oct 2021
- First submitted
- 24 Jun 2018
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang CJ, Gu HQ, Zong LX, Zhang XM, Zhou Q, Jiang Y, Li H, Meng X, Yang X, Wang M, Huo XC, Wangqin RQ, Bei YZ, Qi XH, Liu XY, Hu SQ, Wang ZM, Zhao XQ, Wang YL, Liu LP, Ma XD, Morgan L, Xian Y, Schwamm LH, Wang YJ, Li ZX; IMPROVE Stroke Care in China investigators. Effectiveness of a Quality Improvement Intervention on Reperfusion Treatment for Patients With Acute Ischemic Stroke: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2316465. doi: 10.1001/jamanetworkopen.2023.16465.
PubMed 37266940Li Z, Wang C, Zhang X, Zong L, Zhou H, Gu H, Jiang Y, Pan Y, Meng X, Zhou Q, Zhao H, Yang X, Wang M, Xiong Y, Zhao X, Wang Y, Liu L, Ma X, Morgan L, Xian Y, Schwamm LH, Wang Y. Rationale and design of a stepped wedge cluster randomised trial to improve acute reperfusion treatment quality for stroke: IMPROVE stroke care in China. Stroke Vasc Neurol. 2022 Oct;7(5):451-456. doi: 10.1136/svn-2021-001461. Epub 2022 Mar 30.
PubMed 35354662
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improve Acute Reperfusion Treatment Quality for Stroke in China
- ClinicalTrials.gov ID
- NCT03578107
- Acronym / sponsor ID
- KY 2018-044-01
- Conditions
- Ischemic Stroke
- Keywords
- acute ischemic stroke, IV-tPA, endovascular treatment, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,895 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 5 Jul 2018 (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.
In order to bridge the great gaps, Chinese Stroke Association (CSA) and American Heart Association (AHA) sought to develop, conduct, and assess a multifaceted quality improvement intervention to increase the adherent rate of IV tPA and ET and improve 3-month clinical outcomes for these patients through our cluster-randomized stepped-wedge IMPROVE: Stroke in China trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Improvement intervention1 | Other | Behavioral: improvement of quality of stroke carereceive the following improvement intervention for 18 months： |
| Improvement intervention2 | Other | Behavioral: improvement of quality of stroke carereceive the following improvement intervention for 12 months： |
| Improvement intervention3 | Other | Behavioral: improvement of quality of stroke carereceive the following improvement intervention for 6 months： |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Hospitals：
- Voluntary.
- Hospitals from CSCA.
- Secondary or tertiary public hospitals with an emergency department and neurologic wards that receive patients with AIS.
- Have a 24*7 on-call stroke team.
Key exclusion criteria (6 listed)
- Hospitals：
- Hospitals that can not comply with the protocol and finish the research.
- Grade-one hospitals and non cerebral vascular disease specialized hospitals.
- Hospitals involved in other stroke care quality improvement projects or relevant clinical trials.
- Patients：
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 |
|---|---|---|
| improvement of quality of stroke care1. hospital tool kits for quality improvement of reperfusion therapy ; 2. organizational stakeholder and opinion leader meetings; 3. data monitoring and feedback reports； 4. webinar for hospital teams | Behavioural | Improvement intervention1, Improvement intervention2, Improvement intervention3 |
Primary outcome
The adherence rate of guidelines for IV-tPA and/or endovascular treatment in eligible patients.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
6 secondary outcomes
proportional change of intravenous thrombolytic therapy in eligible patients 4.5h after the onset
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
proportional change of endovascular treatment in eligible patients 6h after the onset
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
time from arrival to hospitals to intravenous thrombolytic therapy
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
door-to-puncture time
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
in-hospital mortality
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
3-month disability（mRS≥3 ）
Time frame: patients will be followed up at 3 months
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 2 Nov 2021.
- Derived from this study: PubMed 37266940Wang CJ, Gu HQ, Zong LX, Zhang XM, Zhou Q, Jiang Y, Li H, Meng X, Yang X, Wang M, Huo XC, Wangqin RQ, Bei YZ, Qi XH, Liu XY, Hu SQ, Wang ZM, Zhao XQ, Wang YL, Liu LP, Ma XD, Morgan L, Xian Y, Schwamm LH, Wang YJ, Li ZX; IMPROVE Stroke Care in China investigators. Effectiveness of a Quality Improvement Intervention on Reperfusion Treatment for Patients With Acute Ischemic Stroke: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2316465. doi: 10.1001/jamanetworkopen.2023.16465.
- Derived from this study: PubMed 35354662Li Z, Wang C, Zhang X, Zong L, Zhou H, Gu H, Jiang Y, Pan Y, Meng X, Zhou Q, Zhao H, Yang X, Wang M, Xiong Y, Zhao X, Wang Y, Liu L, Ma X, Morgan L, Xian Y, Schwamm LH, Wang Y. Rationale and design of a stepped wedge cluster randomised trial to improve acute reperfusion treatment quality for stroke: IMPROVE stroke care in China. Stroke Vasc Neurol. 2022 Oct;7(5):451-456. doi: 10.1136/svn-2021-001461. Epub 2022 Mar 30.
- 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.
Yongjun Wang, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing improvement of quality of stroke care in people with 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 11 inclusion and 6 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 2 Nov 2021. 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 adherence rate of guidelines for IV-tPA and/or endovascular treatment in eligible patients. (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?
On the ClinicalTrials.gov record for NCT03578107, which also lists 2 linked publications.
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 2 Nov 2021.