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Recruiting NCT05679986

Early Neurological Deterioration in Recent Small Subcortical Infarction

Conditions: Cerebral Infarction, Subcortical Infarction, Deterioration, Clinical, Progression

Sex: All
Ages: 18 Years – N/A
Enrollment: 1000
Sponsor: Yuan Gao

Location: China

Summary

Recent small subcortical infarction (RSSI) is defined as a small deep infarction in the territory of a perforating artery with maximum axial diameters (MAD) of less than 20 mm. Although RSSI is generally considered to be of a relatively favorable prognosis, about 13.5% to 43% of RSSI patients experience early neurological deterioration (END) in the acute phase, which often bring adverse effects on long-term outcomes. Although a number of risk factors for END have been identified previously, however, the risk factors of END and the underlying etiological mechanism are still ambiguous, and also the relevant intervention measures lack sufficient evidences, which is a thorny problem that clinicians have to face.In this multicenter, large-sample prospective registry study, we ought to investigate the natural course of END in patients with RSSI. Exploring the risk factors and potential mechanism of its occurrence and development, and trying to establish a comprehensive predictive model for END that integrates multi-dimensional information including clinical symptom, demographic data, biochemical biomarker and image data, and so as to provide a valuable tool for clinical evaluation and early management. Simultaneously, our study will provide information for the design of therapeutic randomized controlled trials in the future.

Eligibility Criteria

Inclusion Criteria:Age ≥ 18 years;Time from the last seen normal to enrollment ≤ 72 h.Completion of brain MRI (T1/T2/Flair/DWI sequences at least). The lesion belonged to the territory of the penetrating artery( lenticulostriate area and pons) on the DWI sequence and at least one of the vascular examinations such as MRA, CTA or DSA was completed.Exclusion Criteria:Patients with low imaging quality affecting the evaluation of the data;Vascular malformations, aneurysms, intracranial hemorrhagic diseases, brain abscesses, malignant space occupying lesions or other non-ischemic intracranial lesions;Patients with combined malignancy, hematological disease and other systemic diseases with possible hypercoagulable state;pre-stroke mRS ≥2 ;END occurred before the completion of brain MRI after admission;Acute endovascular treatment had been received or was planed to be done;Pregnant or lactating women;Participating in another ongoing study;Refused to participate in the study.

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Source: ClinicalTrials.gov (NCT05679986). StuddyBuddy aggregates publicly available trial information.