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

Yi Yang

Status: Enrolling

Conditions: Acute Ischemic Stroke

Treatments: Procedure: Remote ischemic conditioning; Procedure: Sham remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05915832

RICCH-IS

Details and patient eligibility

About

The purpose of this study is to determine the impact of remote ischemic conditioning on cerebral hemodynamics in patients with ischemic stroke.

Full description

Current studies have shown that remote ischemic conditioning can activate neuronal signals and humoral factors, increase cerebral perfusion and promote neurological recovery in patients with ischemic stroke.The purpose of this study was to investigate the effect of remote ischemic conditioning on cerebral hemodynamics in patients with acute ischemic stroke.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

RIC

Active Comparator group

Description:

Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days.

Treatment:

Procedure: Remote ischemic conditioning

Sham RIC

Placebo Comparator group

Description:

Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days.

Treatment:

Procedure: Sham remote ischemic conditioning