Clinical trial NCT05125861: Dynamic Cerebral Autoregulation of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
Official title: Dynamic Cerebral Autoregulation of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Remote Ischemic Conditioning
Keywords: Remote Ischemic Conditioning
Dynamic Cerebral Autoregulation
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 80
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 dynamic cerebral autoregulation in patients with acute ischemic stroke receiving intravenous thrombolysis.

Detailed description: In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times within 6 hours to 24 hours from thrombolysis . Both groups underwent dynamic cerebral autoregulation measurements at days 1 to 2 and 7 to 10 of onset and recorded the relevant indexes, and blood samples were collected before and 24 hours after intravenous thrombolysis, we aimed to determine the impact of remote ischemic conditioning combined with intravenous thrombolysis on dynamic cerebral autoregulation in acute ischemic stroke patients. We hypothesized that remote ischemic conditioning would improve dynamic cerebral autoregulation in patients with acute ischemic stroke receiving intravenous thrombolysis.

Eligibility criteria: Inclusion Criteria:

1. Age≥18 years, \< 80 years, regardless of sex;
2. Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
3. Baseline NIHSS \>= 5, and \<= 25;
4. Baseline GCS ≥8;
5. Signed and dated informed consent is obtained

Exclusion Criteria:

1. Patients who undergo endovascular treatment;
2. mRS ≥ 2 before the onset of the disease;
3. Severe organ dysfunction or failure;
4. Those who have a history of atrial fibrillation;
5. The patients who have 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;
6. Pregnant or lactating women;
7. Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
8. 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;
9. Other conditions that the researchers think are not suitable for the group.

Primary outcomes:
measure: Dynamic cerebral autoregulation of affected sides measured by phase difference(PD) in Degree
timeFrame: 1-2 days
Secondary outcomes:
measure: Dynamic cerebral autoregulation of unaffected sides measured by phase difference(PD) in Degree
timeFrame: 1-2 days
measure: Dynamic cerebral autoregulation of affected sides measured by phase difference(PD) in Degree
timeFrame: 7-10 days
measure: Dynamic cerebral autoregulation of unaffected sides measured by phase difference(PD) in Degree
timeFrame: 7-10 days
measure: Hematology related indicators
timeFrame: before and 24 hours after intravenous thrombolysis
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References: