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Completed

NCT Number: NCT03578107

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
  • 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.

Exclusion criteria

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

Treatment and study plan

improvement of quality of stroke care

Behavioral
  • hospital tool kits for quality improvement of reperfusion therapy ;
  • organizational stakeholder and opinion leader meetings;
  • data monitoring and feedback reports;
  • webinar for hospital teams

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. door-to-puncture time

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  5. in-hospital mortality

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  6. 3-month disability(mRS≥3 )

    Time frame: patients will be followed up at 3 months

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Improve Acute Reperfusion Treatment Quality for Stroke in China

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2018
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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