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Improve Acute Reperfusion Treatment Quality for Stroke in China, IMPROVE: Stroke Care in China

Improve Acute Reperfusion Treatment Quality for Stroke in China

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03578107
Enrollment
15895
Registered
2018-07-05
Start date
2018-07-01
Completion date
2020-10-31
Last updated
2021-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

acute ischemic stroke, IV-tPA, endovascular treatment, intervention

Brief 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 cluster-randomized stepped-wedge IMPROVE: Stroke in China trial.

Interventions

BEHAVIORALimprovement of quality of stroke care

1. 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

Sponsors

American Heart Association
CollaboratorOTHER
Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Hospitals: 1. Voluntary. 2. Hospitals from CSCA. 3. Secondary or tertiary public hospitals with an emergency department and neurologic wards that receive patients with AIS. 4. Have a 24\*7 on-call stroke team. 5. Have the capacity of IV rt-PA thrombolytic therapy or/and endovascular treatment. 6. Implement at least 10 patients' rt-PA or/and endovascular treatment during the last year. 7. Admit at least 5 patients of acute ischemic stroke within 24 hours after onset each month. 8. Have full desire to improve the procedure of treatment of acute ischemic stroke. 9. 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.

Exclusion criteria

Hospitals: 1. Hospitals that can not comply with the protocol and finish the research. 2. Grade-one hospitals and non cerebral vascular disease specialized hospitals. 3. Hospitals involved in other stroke care quality improvement projects or relevant clinical trials. Patients: 1)Patients refuse to participate in this study

Design outcomes

Primary

MeasureTime frame
The adherence rate of guidelines for IV-tPA and/or endovascular treatment in eligible patients.participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary

MeasureTime frame
proportional change of endovascular treatment in eligible patients 6h after the onsetparticipants will be followed for the duration of hospital stay, an expected average of 2 weeks
time from arrival to hospitals to intravenous thrombolytic therapyparticipants will be followed for the duration of hospital stay, an expected average of 2 weeks
proportional change of intravenous thrombolytic therapy in eligible patients 4.5h after the onsetparticipants will be followed for the duration of hospital stay, an expected average of 2 weeks
in-hospital mortalityparticipants will be followed for the duration of hospital stay, an expected average of 2 weeks
3-month disability(mRS≥3 )patients will be followed up at 3 months
door-to-puncture timeparticipants will be followed for the duration of hospital stay, an expected average of 2 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026