Clinical trial NCT04980651: Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke
Official title: Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke: A Multicenter, Randomized, Parallel-controlled Clinical Trial
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: 2021-07-28
Enrollment: 2210
Sex: ALL
Minimum age (years): 18
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 for acute ischemic stroke.

Detailed description: In this study, 2210 cases of ischemic stroke in 72 hours were included in 10 centers in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 7 consecutive days. Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning in treating acute ischemic stroke.

Eligibility criteria: Inclusion Criteria:

* 1) Age≥18 years, regardless of sex.
* 2) Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 72 hours of stroke onset.
* 3) Baseline NIHSS ≥ 4, ≤ 24.
* 4) Baseline mRS ≤ 2;
* 5) Signed and dated informed consent is obtained.

Exclusion Criteria:

* 1) Patients who undergo thrombolytic therapy or endovascular treatment.
* 2) The patients who had 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.
* 3) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumors,s and other diseases involving the brain.
* 4) Pregnant or lactating women.
* 5) Previous remote ischemic conditioning therapy or similar treatment.
* 6) Severe hepatic and renal dysfunction.
* 7) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons.
* 8) Unwilling to be followed up or treated for poor compliance.
* 9) 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.
* 10) Other conditions that the researchers think are not suitable for the group.

Primary outcomes:
measure: Proportion of patients with modified Rankin Scale (mRS) Score 0-2.
timeFrame: 3 months
Secondary outcomes:
measure: National Institute of Health stroke scale (NIHSS) at 7 days, 30±3 days, 90±3 days from onset.
timeFrame: 7days, 30±3 days, 90±3 days
measure: modified Rankin Scale (mRS) Score at 7 days, 30±3 days, 90±3 days from onset.
timeFrame: 7days, 30±3 days, 90±3 days
measure: Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset.
timeFrame: 7days, 30±3 days, 90±3 days
measure: Proportion of patients with hemorrhagic transformation during hospitalization.
timeFrame: 7 days
measure: Frequency of adverse events during follow-up.
timeFrame: 90 days
Other outcomes:
measure: Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days.
timeFrame: 24 hours, 7 days, 30±3 days, 90±3 days
measure: heart rate at 24 hours, 7 days, 30±3 days, 90±3 days.
timeFrame: 24 hours, 7 days, 30±3 days, 90±3 days
measure: Numeric rating scales (NRS) score during intervention.
timeFrame: 7 days
measure: Proportion of patients with early withdrawal for safety or tolerability reasons.
timeFrame: 7 days
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References: