NCT06009315 Prognostic Prediction Model of Patients With AcUte Stroke undeRgoing EndOvascular TheRApy (AURORA)
| NCT ID | NCT06009315 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Acute Ischemic Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 949 participants |
| Start Date | 2024-02-23 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 949 participants in total. It began in 2024-02-23 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06009315 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06009315 currently recruiting?
Yes, NCT06009315 is actively recruiting participants. Contact the research team at ruquan.han@gmail.com for enrollment information.
Where is the NCT06009315 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06009315 clinical trial?
NCT06009315 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 949 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.