Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

— SERICT-AIS  

Official title:

Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04027621
• Other study ID #: SERICT-AIS
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: July 20, 2020

Study information

• Verified date: June 2022
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 20, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• remote ischemic conditioning
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.
• sham 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Chang chun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes of hematological indicators	Hematological samples are collected at right before thrombolysis and 24 hours after thrombolysis, and changes of hematological indicators related to hemorrhagic transformation (such as Axl, ANGPTL4) are compared between the two groups.	24 hours
Other	Changes of the function of dynamic cerebral autoregulation	The function of patients' dynamic cerebral autoregulation are tested 3 times within 10 days from onset and compared between the two groups.	10 days
Primary	Frequency of adverse events during hospitalization	All adverse events until day-7 or discharge (whichever is earlier)	7 days
Primary	Frequency of adverse events during follow-up	Severe adverse events through day-90 after the onset of acute ischemic stroke.	3 months
Secondary	National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge	National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge. Ranged from 0 to 42, a low value represents a better outcome.	7 days
Secondary	Proportion of patients with Modified Rankin Scale (mRS) Score 0-2	Proportion of patients with Modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.	3 months