Acute Ischemic Stroke
Conditions
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, 558 cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from the onset are included in 18 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 combined with intravenous thrombolysis in treating acute ischemic stroke.
Interventions
PROCEDURERemote ischemic conditioning
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 inflations of a blood pressure cuff to 200 mm Hg.
PROCEDURESham remote ischemic conditioning
Sham 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 inflations of a blood pressure cuff to 60 mm Hg.
Sponsors
Yi Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\) Age≥18 years, regardless of sex; * 2\) Patients with a clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis with alteplase; * 3\) Pre-thrombolysis NIHSS \>= 4, and \<= 24; * 4\) Premorbid mRS 0-1; * 5\) Signed and dated informed consent is obtained;
Exclusion criteria
* 1\) Patients who have the contraindication of intravenous thrombolysis with alteplase. * 2\) 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. * 3\) Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc. * 4\) Pregnant or lactating women. * 5\) Severe hepatic and renal dysfunction. * 6\) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons. * 7\) Unwilling to be followed up or treated for poor compliance. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with Modified Rankin Scale (mRS) Score 0-1 | 3 months | Proportion of patients with Modified Rankin Scale (mRS) Score 0-1. Ranged from 0 to 6, a low value represents a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barthel Index (BI) at 24 hours, and 7 days after IVT. | 24 hours, 7 days | Barthel Index (BI) at 24 hours, and 7 days after IVT. Ranged from 0 to 100, a high value represents a better outcome. |
| Proportion of patients with modified Rankin Scale (mRS) Score 0-2 at 90±3 days after IVT. | 90±3 days | Proportion of patients with modified Rankin Scale (mRS) Score 0-2 at 90±3 days after IVT. mRS: Ranged from 0 to 6, a low value represents a better outcome. |
| Frequency of adverse events during follow-up | 90 days | All adverse events through 90 days. |
| National Institute of Health stroke scale (NIHSS) at 24 hours, and 7 days after IVT. | 24 hours, 7 days | National Institute of Health stroke scale (NIHSS) at 24 hours, and 7 days after IVT. Ranged from 0 to 42, a low value represents a better outcome. |
| Mortality within 90 days. | 90 days | Mortality within 90 days. |
| Stroke recurrence rate within 90 days. | 90 days | Stroke recurrence rate within 90 days. |
| Frequency of Hemorrhagic transformation within 24 hours after IVT. | 24 hours | Frequency of Hemorrhagic transformation within 24 hours after IVT. |
Countries
China
Outcome results
None listed