Acute Ischemic StrokeAURORANCT06009315
Prognostic Prediction Model of Patients With AcUte Stroke undeRgoing EndOvascular TheRApy (AURORA)
An observational study of Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Stroke is the leading cause of disability-adjusted life years (DALYs) in China, imposing a heavy burden on society and families. Endovascular therapy (EVT) has opened the 2.0 era of acute ischemic stroke (AIS) treatment, but still up to 1/3 of patients have poor neurological prognosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 949 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2024to 31 Dec 2026
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ischemic stroke caused by large undergoing endovascular therapy
Who may be able to join
- Age ≥18 years;
- NIHSS score ≥4;
- Image-confirmed (CTA/MRA/DSA) intracranial large artery occlusion;
- ASPECT (anterior circulation) or PC-ASPECT (posterior circulation) score ≥3;
- Endovascular treatment including arterial thrombolysis, mechanical thrombolysis, and angioplasty (onset to puncture time is recommended to be less than 8 hours for anterior circulation and less than 12 hours for posterior circulation; those exceeding the time window will be determined by the neurointerventionalist through imaging assessment);
- Signed informed consent by the patient or legal representative
Who cannot join
- Pre-stroke mRS score >2;
- Intracranial bleeding disorders: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
- presence of coagulation disorders, history of systemic bleeding, history of thrombocytopenia or neutropenia;
- Renal insufficiency with elevated blood creatinine (greater than 2 times the upper limit of normal);
- Presence of severe cardiopulmonary disease that, in the opinion of the investigator, makes participation in this study unsuitable; patients with a life expectancy of less than 3 months or otherwise unable to complete this study;
- Contraindication to DSA examination, severe contrast allergy or absolute contraindication to iodine contrast; women of childbearing age who have a negative pregnancy test but refuse to use effective contraception, are pregnant or breast feeding;
- Those who are unable to complete the study due to psychiatric disorders, cognitive or mood disorders;
- Other patients who, in the opinion of the investigator, are not suitable for enrollment in the study (specify reason).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Ruquan Han, M.D., Ph.D, 8610-59976660, ruquan.han@gmail.com
Ruquan Han, M.D., Ph.D
About this study
Official title: Development and Validation for Prognostic Prediction Model of Patients With AcUte Stroke undeRgoing EndOvascular TheRApy (AURORA)
Stroke is the leading cause of disability-adjusted life years (DALYs) in China, imposing a heavy burden on society and families. Endovascular therapy (EVT) has opened the 2.0 era of acute ischemic stroke (AIS) treatment, but still up to 1/3 of patients have poor neurological prognosis. The results of several studies at home and abroad and by our team indicate that anesthesia method and perioperative management are one of the key factors affecting the neurological prognosis of EVT treatment in AIS patients. Based on machine learning big data analysis methods, a prognostic model for EVT treatment of AIS patients can be established to guide individualized treatment decisions. Current prediction models only include patients' baseline variables, and lack the inclusion of intraoperative (anesthesia management and interventional process) and postoperative (intensive monitoring treatment) variables, which limits the clinical application of prediction tools. We will establish a large prospective cohort database including preoperative, intraoperative, and postoperative variables, integrate heterogeneous information from multiple sources based on artificial intelligence machine learning algorithms, and build prognostic prediction models with better clinical applicability and calibration, with the aim of optimizing perioperative management of endovascular therapy, guiding individualized clinical decision-making, and improving patients' clinical prognosis.
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke,, Anesthesia, Predictive Model, Endovascular therapy, Deep learning
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional independence at 90 days
modified Rankin Scale of 0-2
Measured: 90±7days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start23 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 949 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009315
- Sponsor's protocol ID
- LF20230819
- Acronym
- AURORA
- Status last verified
- Jul 2024
- First submitted
- 19 Aug 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang X, Liang F, Wu Y, Jia B, Wang A, Zhang X, Zhang K, Hou X, Jian M, Wang Y, Liu H, Miao Z, Han R. Development and Validation of a Two-step Model to Predict Outcomes After Endovascular Treatment for Patients With Acute Ischemic Stroke. J Neurosurg Anesthesiol. 2025 Jul 1;37(3):305-312. doi: 10.1097/ANA.0000000000001008. Epub 2024 Sep 18.
PubMed 39291867
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation for Prognostic Prediction Model of Patients With AcUte Stroke undeRgoing EndOvascular TheRApy (AURORA)
- ClinicalTrials.gov ID
- NCT06009315
- Acronym / sponsor ID
- AURORA / LF20230819
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke,, Anesthesia, Predictive Model, Endovascular therapy, Deep learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 949 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Aug 2023 (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.
Stroke is the leading cause of disability-adjusted life years (DALYs) in China, imposing a heavy burden on society and families. Endovascular therapy (EVT) has opened the 2.0 era of acute ischemic stroke (AIS) treatment, but still up to 1/3 of patients have poor neurological prognosis. The results of several studies at home and abroad and by our team indicate that anesthesia method and perioperative management are one of the key factors affecting the neurological prognosis of EVT treatment in AIS patients. Based on machine learning big data analysis methods, a prognostic model for EVT treatment of AIS patients can be established to guide individualized treatment decisions. Current prediction models only include patients' baseline variables, and lack the inclusion of intraoperative (anesthesia management and interventional process) and postoperative (intensive monitoring treatment) variables, which limits the clinical application of prediction tools. We will establish a large prospective cohort database including preoperative, intraoperative, and postoperative variables, integrate heterogeneous information from multiple sources based on artificial intelligence machine learning algorithms, and build prognostic prediction models with better clinical applicability and calibration, with the aim of optimizing perioperative management of endovascular therapy, guiding individualized clinical decision-making, and improving patients' clinical prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke caused by large undergoing endovascular therapy
Key inclusion criteria (6 listed)
- Age ≥18 years;
- NIHSS score ≥4;
- Image-confirmed (CTA/MRA/DSA) intracranial large artery occlusion;
- ASPECT (anterior circulation) or PC-ASPECT (posterior circulation) score ≥3;
- Endovascular treatment including arterial thrombolysis, mechanical thrombolysis, and angioplasty (onset to puncture time is recommended to be less than 8 hours for anterior circulation and less than 12 hours for posterior circulation; those exceeding the time window will be determined by the neurointerventionalist through imaging assessment);
Key exclusion criteria (8 listed)
- Pre-stroke mRS score >2;
- Intracranial bleeding disorders: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
- presence of coagulation disorders, history of systemic bleeding, history of thrombocytopenia or neutropenia;
- Renal insufficiency with elevated blood creatinine (greater than 2 times the upper limit of normal);
- Presence of severe cardiopulmonary disease that, in the opinion of the investigator, makes participation in this study unsuitable; patients with a life expectancy of less than 3 months or otherwise unable to complete this study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional independence at 90 days
Time frame: 90±7days after treatment
modified Rankin Scale of 0-2
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 1 Aug 2024.
- Derived from this study: PubMed 39291867Wang X, Liang F, Wu Y, Jia B, Wang A, Zhang X, Zhang K, Hou X, Jian M, Wang Y, Liu H, Miao Z, Han R. Development and Validation of a Two-step Model to Predict Outcomes After Endovascular Treatment for Patients With Acute Ischemic Stroke. J Neurosurg Anesthesiol. 2025 Jul 1;37(3):305-312. doi: 10.1097/ANA.0000000000001008. Epub 2024 Sep 18.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 6 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: looking for participants now, as of the sponsor's last update on 1 Aug 2024. 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?
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 Ruquan Han (8610-59976660, ruquan.han@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional independence at 90 days (time frame: 90±7days after treatment). 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 NCT06009315, which also lists 1 linked publication.
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 1 Aug 2024.