Prognostic Prediction Model of Patients With AcUte Stroke undeRgoing EndOvascular TheRApy (AURORA)

Acute Ischemic Stroke Clinical Trial

— AURORA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06009315
• Other study ID #: LF20230819
• Status: Not yet recruiting
• Start date: September 10, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: Beijing Tiantan Hospital
• Contact: Ruquan Han
• Phone: 8610-59976660
• Email: ruquan.han[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 949
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional independence at 90 days	modified Rankin Scale of 0-2	90±7days after treatment