Early Neurological Deterioration in Recent Small Subcortical Infarction

NCT05679986 | Unknown

• 1 other identifier: 2022-KY-1334-002
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Infarction; Subcortical Infarction; Deterioration, Clinical; Progression

Keywords

Early Neurological Deterioration; Recent Small Subcortical Infarction

Outcome Measures

Primary Outcomes (1)

• Early Neurological Deterioration

  any increase of ≥ 2 points in the total NIHSS score or ≥ 1 point on the motor items of the NIHSS within 7 days after admission

  within 7 days after admission

Secondary Outcomes (6)

• Percentage of patients with favorable functional recovery

  12 months

• Percentage of patients with new vascular events

  12 months

• Percentage of patients with new clinical vascular events

  12 months

• Severe bleeding

  12 months

• All-cause mortality

  12 months

Study Arms (1)

Recent small subcortical infarction within 72 hours from stroke onset to admission

Recent small subcortical infarction (RSSI) is defined as small deep infarctions in the territory of perforating arteries with maximum axial diameters (MAD) of less than 20 mm. In this study, RSSIs in the territories of lenticulostriate area, pons are enrolled.

Other: no intervention

Interventions

no intervention OTHER

no intervention

Recent small subcortical infarction within 72 hours from stroke onset to admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

prospectively enroll consecutive patients with acute RSSI within 72 hours of onset January 2015 to January 2024.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuan Gao: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Cerebral Infarction; Clinical Deterioration; Disease Progression

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Disease Attributes

Study Officials

• Yuan Gao, doctor

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Gao, doctor

CONTACT

13949113087; fccgaoy1@zzu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 25, 2022
• First Posted: January 11, 2023
• Study Start: January 1, 2015
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

CN (1)