Using ischemic post-conditioning to improve outcomes in stroke patients undergoing thrombectomy
Efficacy and Safety of Ischemic Post-conditioning in Patients with Acute Ischemic Stroke After Mechanical Thrombectomy
This study is testing if a new method called ischemic post-conditioning can help stroke patients recover better after a procedure to remove a blood clot.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Capital Medical University Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT05789823 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of ischemic post-conditioning as a neuroprotective strategy in patients with acute ischemic stroke undergoing mechanical thrombectomy. The study employs a dose-escalation approach to assess the tolerability of ischemic post-conditioning over a duration of 5 minutes across four cycles. By comparing outcomes between patients receiving both treatments and those receiving only mechanical thrombectomy, the trial aims to determine if the addition of ischemic post-conditioning can enhance recovery and reduce reperfusion injury. The trial is designed for patients who have experienced a stroke within the last 24 hours and meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced an acute ischemic stroke within 24 hours and meet specific clinical criteria.
Not a fit: Patients with confirmed cerebral vasculitis or those who have experienced complications during thrombectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for stroke patients undergoing thrombectomy.
How similar studies have performed: While ischemic post-conditioning has shown promise in animal models, this approach is still being evaluated in human subjects, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years; 2. Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture; 3. Previous mRS ≤ 2; 4. Baseline NIHSS ≥ 6; 5. Baseline ASPECTS ≥ 6; 6. Unilateral middle cerebral artery occlusion with or without ipsilateral internal carotid artery occlusion; 7. Successful recanalization after mechanical thrombectomy (eTICI 2b-3); 8. Written informed consent provided by the patients or their legal relatives. Exclusion Criteria: 1. Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia; 2. Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning; 3. Complications related to thrombectomy, such as contrast agent extravasation, vascular perforation/rupture, dissection, and escape of thrombus; 4. Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy; 5. \> 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy; 6. Patients with contraindications to MRI; 7. Other conditions that the investigator considered inappropriate for inclusion.
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Huanhu Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xunming Ji, MD
- Email: jixm@ccmu.edu.cn
- Phone: 010-83198952
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.