Evaluating the effects of direct ischemic post-conditioning on acute stroke patients

Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion: A Randomized Controlled Pilot Trial

This study is testing if adding a special treatment called direct ischemic post-conditioning to standard stroke therapy can help reduce brain damage in patients who have just had a stroke.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Huanhu Hospital (other)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06545734 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of direct ischemic post-conditioning (IPostC) in reducing ischemic-reperfusion injury in acute stroke patients who have undergone endovascular thrombectomy. Participants will be randomly assigned to receive either endovascular therapy alone or endovascular therapy combined with direct IPostC, which involves mechanical interruptions of reperfusion. The study will assess outcomes such as infarct volume and clinical parameters, while also exploring the biological mechanisms behind direct IPostC through multi-omics analysis.

Who should consider this trial

Good fit: Ideal candidates include patients with ischemic stroke confirmed by imaging and large vessel occlusion who are eligible for endovascular thrombectomy.

Not a fit: Patients with conditions that interfere with neurological assessment or those with serious, advanced, or terminal illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for acute stroke patients with large vessel occlusion.

How similar studies have performed: While the approach of direct ischemic post-conditioning is innovative, similar studies have shown promise in neuroprotection strategies for stroke, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Ischemic stroke confirmed by CT or MRI.
2. Large vessel occlusion confirmed by CTA or MRA, including the intracranial internal 3. carotid artery (ICA) and middle cerebral artery (MCA M1/M2).

4\. Recanalization of the occluded vessel at eTICI grade 2b/3, confirmed by DSA after thrombectomy.

5\. The patient or legally authorized representative has signed an informed consent form.

Exclusion Criteria:

1. Inability to perform an MRI or CT scan for any reason.
2. Presence of any condition that would interfere with neurological assessment or any psychiatric disorders.
3. Stroke onset accompanied by seizures, resulting in the inability to obtain an accurate NIHSS baseline.
4. Pregnancy.
5. Presence of other serious, advanced, or terminal illnesses.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Huanhu Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Ming Wei, MD, PhD

Conditions: Stroke, Acute, Neuroprotection, Ischemic Conditioning, Large Vessel Occlusion