Prognostic prediction model for patients with acute stroke undergoing endovascular therapy

Development and Validation for Prognostic Prediction Model of Patients With AcUte Stroke undeRgoing EndOvascular TheRApy (AURORA)

This study is trying to create a tool that helps doctors predict how well patients with acute stroke will do after they receive a specific treatment called endovascular therapy.

Quick facts

• Study type: Observational
• Enrollment: 949 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06009315 on ClinicalTrials.gov

What this trial studies

This observational study aims to develop a prognostic prediction model for patients with acute ischemic stroke who are undergoing endovascular therapy. It will utilize machine learning techniques to analyze a large dataset, incorporating not only baseline patient variables but also intraoperative and postoperative factors that may influence neurological outcomes. The goal is to create a more comprehensive tool that can guide individualized treatment decisions and improve patient prognoses. The study will include patients with confirmed intracranial large artery occlusion and will focus on optimizing perioperative management.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a NIHSS score of 4 or higher and confirmed intracranial large artery occlusion.

Not a fit: Patients with pre-stroke mRS scores greater than 2 or those with significant bleeding disorders or renal insufficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this model could significantly enhance the ability to predict patient outcomes after endovascular therapy for acute ischemic stroke.

How similar studies have performed: While there have been studies on predictive models for stroke outcomes, this approach incorporating comprehensive perioperative data is relatively novel.

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).

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ruquan Han

Conditions Acute Ischemic Stroke; Acute ischemic stroke,; Anesthesia; Predictive Model; Endovascular therapy; Deep learning