Clinical trial NCT04027621: Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke
Official title: Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 50
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 efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

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 . Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

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) Double upper limbs or lower limbs paralysis was found in this case;
* 4) Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on;
* 5) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain;
* 6) Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
* 7) Severe organ dysfunction or failure;
* 8) Patients suffering from severe hematological diseases or severe coagulation disorder dysfunction
* 9) Those who have a history of severe trauma or had major surgery within 6 months prior to admission;
* 10) Those who have a history of atrial fibrillation;
* 11) 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;
* 12) Pregnant or lactating women;
* 13) Previous remote ischemic conditioning therapy or similar treatment;
* 14) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
* 15) Severe hepatic and renal dysfunction;
* 16) Unwilling to be followed up or treated for poor compliance;
* 17) 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;
* 18) Other conditions that the researchers think are not suitable for the group.

Primary outcomes:
measure: Frequency of adverse events during hospitalization
timeFrame: 7 days
measure: Frequency of adverse events during follow-up
timeFrame: 3 months
Secondary outcomes:
measure: National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge
timeFrame: 7 days
measure: Proportion of patients with Modified Rankin Scale (mRS) Score 0-2
timeFrame: 3 months
Other outcomes:
measure: Changes of hematological indicators
timeFrame: 24 hours
measure: Changes of the function of dynamic cerebral autoregulation
timeFrame: 10 days
Locations:
city: Chang chun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References: