Using MRI to Select Patients for Endovascular Treatment After Stroke
Patient Selection Based on Penumbra-core Mismatch Using MR With Non-Perfusion Imaging for Endovascular Treatment Within 6 to 24 Hours: Rationale and Trial Design
This study is testing if using MRI results can help doctors choose the right patients for a specific stroke treatment called endovascular thrombectomy when they arrive at the hospital 6 to 24 hours after their symptoms start.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 352 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tianjin Huanhu Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT05735301 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of patient selection for endovascular thrombectomy (EVT) based on MRI findings in patients who present 6 to 24 hours after stroke symptom onset. Participants will be randomly assigned to either a Non-perfusion group, where EVT is administered based on specific MRI criteria indicating penumbra-core mismatch, or a Perfusion group, where EVT is based on perfusion mismatch criteria. Both groups will receive guideline-based medical treatment if they do not qualify for EVT. The study seeks to refine patient selection criteria to improve outcomes in late-presenting stroke patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced an anterior circulation large vessel occlusion and meet specific imaging and clinical criteria.
Not a fit: Patients who are pregnant, have severe allergies to contrast media, or have uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the selection of patients who are most likely to benefit from endovascular treatment, potentially improving recovery outcomes after stroke.
How similar studies have performed: Other studies have explored similar imaging-based patient selection strategies for EVT, showing promising results, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age of 18 years or older； * Anterior circulation LVO (internal carotid artery, or middle cerebral arteries (MCA)M1, M2 proximal segment) confirmed by computed tomographic angiography (CTA)/magnetic resonance angiography (MRA)； * NIHSS score ≥6 at the time of randomization； * ASPECTS score ≥ 6 on NCCT； * Time from stroke onset to randomization within 6-24 hours； * Pre-stroke mRS score 0-2； * Completed MRI and perfusion imaging or enable to complete MRI and/or perfusion imaging； * Signed informed consent Exclusion Criteria: * Pregnancy, or those potential with positive urine or serum beta Human Chorionic Gonadotrop in test； * A history of severe allergy to contrast media； * Uncontrolled hypertension (SBP \>185mmHg; DBP\>110mmHg)； * Hereditary or acquired bleeding tendency, coagulation factor deficiency, recent anticoagulant medication (A platelet count of less than 100 x 109 /L；INR\>3 or PPT more than 3 times normal)； * Active hemorrhage or preexisting tendency to hemorrhage； * Presence of signs of cardiac, hepatic or renal failure； * Baseline blood glucose\<50mg/dL (2.78mmol) or \>400mg/dL (22.20mmol)； * Participation in other interventional randomized clinical trials that may confound the outcome assessment of the trial； * Life expectancy \< 1 year； * Patients who are unable to complete the 90-day follow-up； * A stroke attack with epilepsy that prevents an accurate NIHSS score from being obtained； * Other circumstances that the investigator considers inappropriate for participation in the trial(such as violation of guidelines or institutional processing principles during the screening process).
Where this trial is running
Tianjin, Tianjin Municipality
- TianJinHH — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Ming Wei, doctorate — Tianjin Huanhu Hospital
- Study coordinator: Ming Wei, doctorate
- Email: drweiming@163.com
- Phone: 13502182903
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.