Investigating early neurological deterioration in recent small subcortical infarction
Early Neurological Deterioration in Recent Small Subcortical Infarction：a Prospective Study
This study looks at how some patients with recent small strokes might get worse in their neurological condition and what factors could be involved in that change.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Zhengzhou University Academic / other |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT05679986 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the natural course of early neurological deterioration (END) in patients who have experienced recent small subcortical infarction (RSSI). Patients will be enrolled within 72 hours of stroke onset, and their clinical data will be collected through an electronic case report form. The study will monitor changes in neurological status using the NIHSS score and will investigate potential risk factors and mechanisms associated with END. Follow-up assessments will extend up to one year to evaluate long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who have experienced a recent small subcortical infarction within 72 hours.
Not a fit: Patients with significant pre-existing neurological impairment or those with conditions that may confound the results, such as vascular malformations or ongoing malignancies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of early neurological deterioration in patients with subcortical infarctions.
How similar studies have performed: While there have been studies on neurological deterioration in stroke patients, this specific focus on RSSI and its early deterioration is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years; 2. Time from the last seen normal to enrollment ≤ 72 h. 3. 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: 1. Patients with low imaging quality affecting the evaluation of the data; 2. Vascular malformations, aneurysms, intracranial hemorrhagic diseases, brain abscesses, malignant space occupying lesions or other non-ischemic intracranial lesions; 3. Patients with combined malignancy, hematological disease and other systemic diseases with possible hypercoagulable state; 4. pre-stroke mRS ≥2 ; 5. END occurred before the completion of brain MRI after admission; 6. Acute endovascular treatment had been received or was planed to be done; 7. Pregnant or lactating women; 8. Participating in another ongoing study; 9. Refused to participate in the study.
Where this trial is running
Zhengzhou, Henan
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Principal investigator: Yuan Gao, doctor — The First Affiliated Hospital of Zhengzhou University
- Study coordinator: Yuan Gao, doctor
- Email: fccgaoy1@zzu.edu.cn
- Phone: 13949113087
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.