Acute Ischemic StrokeICB-MRAISNCT06628817
The Intensive Care Bundle with Mortality Reduction in Acute Ischemic Stroke Trial
A study testing The Intensive Care Bundle with Mortality Reduction in people with Acute Ischemic Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Ischemic stroke, also known as cerebral infarction, accounts for as high as 60% to 80% of all stroke cases, and it is characterized by high morbidity, high disability rate, and high mortality rate. 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 Intensive Care Bundle with Mortality Reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age of onset ≥ 18 years old;
- AIS patients admitted to the hospital within 7 days of onset;
- Obtain the informed consent of the patient or his/her family.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Ischemic stroke, also known as cerebral infarction, accounts for as high as 60% to 80% of all stroke cases, and it is characterized by high morbidity, high disability rate, and high mortality rate. In recent years, acute ischemic stroke (AIS) has risen to the top of the list of causes of death in Chinese people, bringing a heavy burden on families, society and the country. In the process of continuous accumulation of evidence-based evidence, the management of stroke has gradually become systematic, and the demand for multi-disciplinary collaboration has become increasingly prominent, thus the concept of organized medical care has emerged.
Improving the prognosis of stroke faces multiple challenges, including timely identification of stroke patients, intravenous thrombolysis after clinical doctors evaluate indications and contraindications, reducing in-hospital stroke complications, accurately diagnosing the cause of stroke and implementing precise prevention. In the past, there were relatively few clinical trials on reducing mortality. The 2023 Dutch PRECIOUS study used metoclopramide, ceftriaxone and acetaminophen to prevent aspiration, infection and fever in elderly patients with acute stroke. The results showed that there was no significant difference in acute 90-day good functional outcomes and reduced mortality. The INTERACT3 trial results showed that for patients with acute cerebral hemorrhage, compared with conventional medical care, the use of a new combination management plan, namely early intensive blood pressure management, strict control of blood sugar elevation, body temperature control and anticoagulation therapy, can significantly reduce the risk of 6-month adverse functional prognosis in patients, improve the survival rate and quality of life of patients, and the possibility of patients being discharged within 7 days. Therefore, the use of a new combination management plan, including improving the efficiency of reperfusion therapy, reducing the occurrence of stroke complications, and carrying out precise etiological treatment, may reduce the mortality rate of patients.
The Zhejiang Stroke Online Platform can monitor the comprehensive information of treatment and management in the process of clinical doctors receiving AIS patients in real time. According to the self-feedback of each unit of the online platform, the provincial center conducts multi-level new combined management intervention on it. The purpose of this study is to explore whether the new combined management intervention measures can reduce the mortality rate of AIS patients on the basis of the implementation of stroke online platform monitoring.
Read the detailed description
Ischemic stroke, also known as cerebral infarction, accounts for as high as 60% to 80% of all stroke cases, and it is characterized by high morbidity, high disability rate, and high mortality rate. In recent years, acute ischemic stroke (AIS) has risen to the top of the list of causes of death in Chinese people, bringing a heavy burden on families, society and the country. In the process of continuous accumulation of evidence-based evidence, the management of stroke has gradually become systematic, and the demand for multi-disciplinary collaboration has become increasingly prominent, thus the concept of organized medical care has emerged.
Improving the prognosis of stroke faces multiple challenges, including timely identification of stroke patients, intravenous thrombolysis after clinical doctors evaluate indications and contraindications, reducing in-hospital stroke complications, accurately diagnosing the cause of stroke and implementing precise prevention. In the past, there were relatively few clinical trials on reducing mortality. The 2023 Dutch PRECIOUS study used metoclopramide, ceftriaxone and acetaminophen to prevent aspiration, infection and fever in elderly patients with acute stroke. The results showed that there was no significant difference in acute 90-day good functional outcomes and reduced mortality. The INTERACT3 trial results showed that for patients with acute cerebral hemorrhage, compared with conventional medical care, the use of a new combination management plan, namely early intensive blood pressure management, strict control of blood sugar elevation, body temperature control and anticoagulation therapy, can significantly reduce the risk of 6-month adverse functional prognosis in patients, improve the survival rate and quality of life of patients, and the possibility of patients being discharged within 7 days. Therefore, the use of a new combination management plan, including improving the efficiency of reperfusion therapy, reducing the occurrence of stroke complications, and carrying out precise etiological treatment, may reduce the mortality rate of patients.
The Zhejiang Stroke Online Platform can monitor the comprehensive information of treatment and management in the process of clinical doctors receiving AIS patients in real time. According to the self-feedback of each unit of the online platform, the provincial center conducts multi-level new combined management intervention on it. The purpose of this study is to explore whether the new combined management intervention measures can reduce the mortality rate of AIS patients on the basis of the implementation of stroke online platform monitoring.
- Conditions
- Acute Ischemic Stroke
- Being tested
- The Intensive Care Bundle with Mortality Reduction
- Keywords
- quality improvement
- 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 Intensive Care Bundle with Mortality ReductionRadiation
a continuous automated medical quality monitoring and feedback system on the online platform, self-feedback and teamwork based on video conferencing, multidisciplinary online education, offline on-site supervision, and standardized intervention in the behavior of medical actors in the process of stroke treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Hospitals assigned to the experimental group will receive a combined management intervention based on self-feedback from the online platform, including: a continuous automated medical quality monitoring and feedback system on the online platform, self-feedback and teamwork based on video conferencing, multidisciplinary online education, offline on-site supervision, and standardized intervention in the behavior of medical actors in the process of stroke treatment. Receives: Radiation: The Intensive Care Bundle with Mortality Reduction |
| No intervention | No intervention | Hospitals in the control group only received self-feedback from the online platform in the neurology department, without receiving combined management intervention. / The neurology department of the control group hospitals only received self-feedback from the online platform, without receiving combined management intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified rankin scale (mRS) scores of 4-6 at 1 year after acute stroke therapy
Modified rankin scale (mRS) scores of 4-6 at 1 year after acute stroke therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 55,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Lou, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628817
- Sponsor's protocol ID
- ICB-MRAIS
- Acronym
- ICB-MRAIS
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intensive Care Bundle with Mortality Reduction in Acute Ischemic Stroke Trial
- ClinicalTrials.gov ID
- NCT06628817
- Acronym / sponsor ID
- ICB-MRAIS / ICB-MRAIS
- Conditions
- Acute Ischemic Stroke
- Keywords
- quality improvement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 8 Oct 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.
Ischemic stroke, also known as cerebral infarction, accounts for as high as 60% to 80% of all stroke cases, and it is characterized by high morbidity, high disability rate, and high mortality rate. In recent years, acute ischemic stroke (AIS) has risen to the top of the list of causes of death in Chinese people, bringing a heavy burden on families, society and the country. In the process of continuous accumulation of evidence-based evidence, the management of stroke has gradually become systematic, and the demand for multi-disciplinary collaboration has become increasingly prominent, thus the concept of organized medical care has emerged.
Improving the prognosis of stroke faces multiple challenges, including timely identification of stroke patients, intravenous thrombolysis after clinical doctors evaluate indications and contraindications, reducing in-hospital stroke complications, accurately diagnosing the cause of stroke and implementing precise prevention. In the past, there were relatively few clinical trials on reducing mortality. The 2023 Dutch PRECIOUS study used metoclopramide, ceftriaxone and acetaminophen to prevent aspiration, infection and fever in elderly patients with acute stroke. The results showed that there was no significant difference in acute 90-day good functional outcomes and reduced mortality. The INTERACT3 trial results showed that for patients with acute cerebral hemorrhage, compared with conventional medical care, the use of a new combination management plan, namely early intensive blood pressure management, strict control of blood sugar elevation, body temperature control and anticoagulation therapy, can significantly reduce the risk of 6-month adverse functional prognosis in patients, improve the survival rate and quality of life of patients, and the possibility of patients being discharged within 7 days. Therefore, the use of a new combination management plan, including improving the efficiency of reperfusion therapy, reducing the occurrence of stroke complications, and carrying out precise etiological treatment, may reduce the mortality rate of patients.
The Zhejiang Stroke Online Platform can monitor the comprehensive information of treatment and management in the process of clinical doctors receiving AIS patients in real time. According to the self-feedback of each unit of the online platform, the provincial center conducts multi-level new combined management intervention on it. The purpose of this study is to explore whether the new combined management intervention measures can reduce the mortality rate of AIS patients on the basis of the implementation of stroke online platform monitoring.
Detailed description
Ischemic stroke, also known as cerebral infarction, accounts for as high as 60% to 80% of all stroke cases, and it is characterized by high morbidity, high disability rate, and high mortality rate. In recent years, acute ischemic stroke (AIS) has risen to the top of the list of causes of death in Chinese people, bringing a heavy burden on families, society and the country. In the process of continuous accumulation of evidence-based evidence, the management of stroke has gradually become systematic, and the demand for multi-disciplinary collaboration has become increasingly prominent, thus the concept of organized medical care has emerged.
Improving the prognosis of stroke faces multiple challenges, including timely identification of stroke patients, intravenous thrombolysis after clinical doctors evaluate indications and contraindications, reducing in-hospital stroke complications, accurately diagnosing the cause of stroke and implementing precise prevention. In the past, there were relatively few clinical trials on reducing mortality. The 2023 Dutch PRECIOUS study used metoclopramide, ceftriaxone and acetaminophen to prevent aspiration, infection and fever in elderly patients with acute stroke. The results showed that there was no significant difference in acute 90-day good functional outcomes and reduced mortality. The INTERACT3 trial results showed that for patients with acute cerebral hemorrhage, compared with conventional medical care, the use of a new combination management plan, namely early intensive blood pressure management, strict control of blood sugar elevation, body temperature control and anticoagulation therapy, can significantly reduce the risk of 6-month adverse functional prognosis in patients, improve the survival rate and quality of life of patients, and the possibility of patients being discharged within 7 days. Therefore, the use of a new combination management plan, including improving the efficiency of reperfusion therapy, reducing the occurrence of stroke complications, and carrying out precise etiological treatment, may reduce the mortality rate of patients.
The Zhejiang Stroke Online Platform can monitor the comprehensive information of treatment and management in the process of clinical doctors receiving AIS patients in real time. According to the self-feedback of each unit of the online platform, the provincial center conducts multi-level new combined management intervention on it. The purpose of this study is to explore whether the new combined management intervention measures can reduce the mortality rate of AIS patients on the basis of the implementation of stroke online platform monitoring.
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 |
|---|---|---|
| Experimental Arm | Experimental | Radiation: The Intensive Care Bundle with Mortality ReductionHospitals assigned to the experimental group will receive a combined management intervention based on self-feedback from the online platform, including: a continuous automated medical quality monitoring and feedback system on the online platform, self-feedback and teamwork based on video conferencing, multidisciplinary online education, offline on-site supervision, and standardized intervention in the behavior of medical actors in the process of stroke treatment. |
| No intervention | No intervention | –Hospitals in the control group only received self-feedback from the online platform in the neurology department, without receiving combined management intervention. / The neurology department of the control group hospitals only received self-feedback from the online platform, without receiving combined management intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of onset ≥ 18 years old;
- AIS patients admitted to the hospital within 7 days of onset;
- Obtain the informed consent of the patient or his/her family.
Key exclusion criteria (1 listed)
- -
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 Intensive Care Bundle with Mortality Reductiona continuous automated medical quality monitoring and feedback system on the online platform, self-feedback and teamwork based on video conferencing, multidisciplinary online education, offline on-site supervision, and standardized intervention in the behavior of medical actors in the process of stroke treatment. | Radiation | Experimental Arm |
Primary outcome
Modified rankin scale (mRS) scores of 4-6 at 1 year after acute stroke therapy
Time frame: 1 year
Modified rankin scale (mRS) scores of 4-6 at 1 year after acute stroke therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing The Intensive Care Bundle with Mortality Reduction in people with Acute Ischemic Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Lou, PhD, MD (86057187783777, lm99@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified rankin scale (mRS) scores of 4-6 at 1 year after acute stroke therapy (time frame: 1 year). 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 8 Oct 2024.