Using remote ischemic conditioning to treat acute moderate posterior ischemic stroke

Remote Ischemic Conditioning for Acute Moderate Posterior Ischemic Stroke (RICAMIS2): a Prospective, Random, Open Label, Blinded End Point, Multi-center Study

This study is testing if a new treatment called remote ischemic conditioning can help people who have had an acute moderate posterior ischemic stroke recover better in the days following their stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 960 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (Academic / other)
• Locations: 1 site (Shenyang)
• Trial ID: NCT06931535 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of remote ischemic conditioning (RIC) on patients suffering from acute moderate posterior ischemic stroke. The approach involves administering RIC within 48 hours of stroke onset to potentially improve neurological outcomes. Previous studies have shown safety and some efficacy of RIC, but this trial aims to provide more robust evidence specifically for posterior circulation strokes. Participants will be monitored for improvements in their neurological status over a 90-day period following treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced their first posterior circulation ischemic stroke within 48 hours and have a specific range of neurological deficits.

Not a fit: Patients with severe hypertension, intracerebral hemorrhage, or other significant contraindications will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance recovery outcomes for patients with acute moderate posterior ischemic stroke.

How similar studies have performed: Previous studies have shown promising results for remote ischemic conditioning in ischemic stroke, but this specific approach for posterior circulation strokes is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years;
* Time from onset to treatment: ≤48 hours;
* Posterior circulation ischemic stroke confirmed by CT or MRI, including patients who have received intravenous thrombolysis or endovascular therapy;
* NIHSS score at randomization: 6-16, with an item 1a (level of consciousness) score of 0-1;
* First-ever stroke or prior stroke without significant residual disability (modified Rankin Scale score ≤1);
* Signed informed consent.

Exclusion Criteria:

* intracerebral hemorrhage or subarachnoid hemorrhage；
* Uncontrolled severe hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg despite antihypertensive therapy)；
* Subclavian artery stenosis ≥ 50% or subclavian steal syndrome;
* Intracranial tumor, arteriovenous malformation or aneurysm;
* Severe abnormalities in coagulation;
* Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc.;
* Participating in other clinical trials within 3 months;
* Comorbidity with any serious diseases and life expectancy is less than half a year;
* Patients not suitable for this clinical studies considered by researcher;

Where this trial is running

Shenyang

• Department of Neurology, General Hospital of Northern Theater Command — Shenyang, China (Recruiting)

Conditions Ischemic Stroke; posterior circulation stroke; remote ischemic conditioning