Using remote ischemic conditioning to treat acute ischemic stroke

Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke: A Multicenter, Randomized, Parallel-controlled Clinical Trial

This study is testing if a new treatment called remote ischemic conditioning can help people recovering from an acute ischemic stroke feel better and improve their safety.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 2210 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Hospital of Jilin University (other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT04980651 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of remote ischemic conditioning (RIC) in patients with acute ischemic stroke. A total of 2210 patients will be randomly assigned to either an experimental group receiving RIC at 200mmHg or a control group receiving sham treatment at 60mmHg, both administered twice daily for seven days. The study will follow participants for 90 days to assess treatment outcomes. The aim is to determine if RIC can improve recovery and safety in stroke patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of acute ischemic stroke who can start treatment within 72 hours of symptom onset.

Not a fit: Patients who have undergone thrombolytic therapy or have contraindications to remote ischemic conditioning will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients suffering from acute ischemic stroke.

How similar studies have performed: While remote ischemic conditioning has been explored in other contexts, this specific application for acute ischemic stroke is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 1) Age≥18 years, regardless of sex.
* 2) Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 72 hours of stroke onset.
* 3) Baseline NIHSS ≥ 4, ≤ 24.
* 4) Baseline mRS ≤ 2;
* 5) Signed and dated informed consent is obtained.

Exclusion Criteria:

* 1) Patients who undergo thrombolytic therapy or endovascular treatment.
* 2) The patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture, or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
* 3) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumors,s and other diseases involving the brain.
* 4) Pregnant or lactating women.
* 5) Previous remote ischemic conditioning therapy or similar treatment.
* 6) Severe hepatic and renal dysfunction.
* 7) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons.
* 8) Unwilling to be followed up or treated for poor compliance.
* 9) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission.
* 10) Other conditions that the researchers think are not suitable for the group.

Where this trial is running

Changchun, Jilin

• The First Hospital of Jilin University — Changchun, Jilin, China (RECRUITING)

Study contacts

• Study coordinator: Yi Yang, MD, PhD

Conditions: Acute Ischemic Stroke