Clinical trial NCT05915832: Effects of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients With Ischemic Stroke
Official title: Effects of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients With Ischemic Stroke(RICCH-IS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

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.

Primary outcomes:
measure: Cerebral autoregulation at 7 days
timeFrame: 0 - 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
References: