Impact of remote ischemic conditioning on blood flow in stroke patients

Effects of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients With Ischemic Stroke(RICCH-IS)

This study is testing if a special treatment that improves blood flow can help stroke patients recover better after their stroke.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Hospital of Jilin University (other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT05915832 on ClinicalTrials.gov

What this trial studies

This study investigates how remote ischemic conditioning affects cerebral hemodynamics in patients who have experienced an acute ischemic stroke. It aims to determine whether this intervention can enhance blood flow to the brain and support neurological recovery. Participants will be randomly assigned to receive either the remote ischemic conditioning treatment or a sham treatment within 72 hours of stroke onset. The study will assess changes in cerebral perfusion and neurological outcomes using established clinical scales.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have a confirmed diagnosis of acute ischemic stroke and can start treatment within 72 hours of symptom onset.

Not a fit: Patients who have undergone thrombolytic or endovascular therapy, or those with severe comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve recovery outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: Previous studies have shown promising results with remote ischemic conditioning in enhancing recovery in stroke patients, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years, \<80 years, both sex;
2. Patients with a clinically definite diagnosis of acute ischemic stroke who are able to commence RIC treatment within 72 hours of stroke onset;
3. Baseline National Institute of Health Stroke Scale (NIHSS) score\<25;
4. Pre-onset modified Rankin Scale (mRS) score ≤ 1;
5. Glasgow Coma Scale score ≥8;
6. Signed and dated informed consent is obtained.

Exclusion Criteria:

1. Patients who have undergone thrombolytic therapy or endovascular therapy;
2. Inability to cooperate sufficiently to complete the cerebral autoregulation examination (e.g., due to a condition such as agitation, drowsiness, arrhythmia, insufficient bilateral temporal bone windows, etc.) during the recording;
3. Presence of other intracranial lesions, such as cerebrovascular malformations, cerebral venous thrombosis, tumors, and other brain lesions;
4. severe hepatic and renal dysfunction or failure;
5. Patients with hematological disease, abnormal coagulation function, bleeding tendency, and platelet \<100×10\^9/L;
6. Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper extremities, venous thrombosis in the acute or subacute stage of upper extremities, arterial occlusive disease, subclavian artery stenosis ≥ 50%, or subclavian steal syndrome;
7. pregnant or lactating women;
8. Previous RIC treatment or similar treatment;
9. Patients with a life expectancy of less than 3 months or patients who are unable to complete the study for other reasons;
10. unwillingness to be followed up or poor treatment adherence;
11. Individuals who are participating in other clinical studies, have participated in other clinical studies within 3 months prior to enrollment, or have participated in this research;
12. Other conditions that the investigator considers inappropriate for enrollment.

Where this trial is running

Changchun, Jilin

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

Study contacts

• Study coordinator: Yi Yang, MD,PhD

Conditions: Acute Ischemic Stroke