Identifying factors for better outcomes in stroke treatment
Predictors of Good Outcomes in Thrombectomy for Stroke Patients Within 24 Hours From Symptom Onset With Large Infarct Core
This study is trying to find out what factors can help people with severe strokes do better after receiving a specific treatment called mechanical thrombectomy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | 115 People's Hospital Government |
| Locations | 4 sites (Cần Thơ and 3 other locations) |
| Trial ID | NCT06016348 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify predictors of favorable clinical outcomes in patients with acute ischemic stroke and large core infarcts who undergo endovascular treatment within 24 hours of symptom onset. The study will analyze data from patients treated with mechanical thrombectomy, focusing on imaging criteria and clinical outcomes. By evaluating the effectiveness and safety of this intervention in a setting where it has not been widely implemented, the study seeks to improve treatment protocols and patient care for stroke victims in Vietnam.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who present with acute ischemic stroke within 24 hours and meet specific imaging criteria for large vessel occlusion and core infarct volume.
Not a fit: Patients who present with acute ischemic stroke more than 24 hours after onset or have significant pre-existing disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies for acute ischemic stroke, potentially improving recovery rates and reducing disability and mortality.
How similar studies have performed: Previous studies have shown the effectiveness of endovascular interventions in similar patient populations, but this specific approach in Vietnam is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Age ≥ 18-year-old
* Patients presenting with acute ischaemic stroke within 24 hours of stroke onset
* Received mechanical thrombectomy within 24 hours of stroke onset
* Imaging criteria include:
* Large vessel occlusion on CT Angiography or MR Angiography (MRA) including tandem occlusion of the internal carotid artery and middle cerebral artery or internal carotid artery.
* Core infarct criteria:
1. ASPECTS ≤5 on non-contrast CT or diffusion-weighted imaging (DWI).
2. ASPECTS score \>5 and core infarct volume of 50-150 ml on CT perfusion (CTP) or reduced cerebral blood flow (rCBF) \<30% on CTP or apparent diffusion coefficient (ADC) \<620 × 10-6 mm2/s on DWI.
Exclusion Criteria:
* Patients presenting with acute ischaemic stroke \>24 hours of stroke onset
* Intracranial hemorrhage identified by CT or MRI
* Pre-stroke modified Rankin Score (mRS) score of \>2 (indicating previous disability)
* Any terminal illness such that the patient has a life expectancy of less than 1 year.
* Patients with active cancer and undergoing treatment for cancer are excluded,
* Pregnancy
Where this trial is running
Cần Thơ and 3 other locations
- Can Tho Central General Hospital — Cần Thơ, Vietnam (Recruiting)
- Da Nang Stroke Center — Da Nang, Vietnam (Recruiting)
- 115 PEOPLE's HOSPITAL — Ho Chi Minh City, Vietnam (Recruiting)
- University Medical Center — Ho Chi Minh City, Vietnam (Recruiting)
Study contacts
- Study coordinator: Quoc-Trung Nguyen, M.D
- Email: quoctrungyds09@gmail.com
- Phone: +84938477516
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.