Safety and Efficacy of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

Safety and Efficacy of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke: A Multicenter, Randomized, Parallel-controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980625
• Other study ID #: SERIC-IVT
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: May 11, 2023

Study information

• Verified date: March 2024
• 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, 558 cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from the onset are included in 13 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: May 11, 2023
• Est. primary completion date: May 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) Baseline NIHSS >= 4, and <= 24;
• 4) Baseline 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. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
• 3) Pregnant or lactating women.
• 4) Previous remote ischemic conditioning therapy or similar treatment;
• 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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Remote 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.
• 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 reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mm Hg.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.	Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.	24 hours, 7 days, 30±3 days, 90±3 days
Other	heart rate at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.	heart rate at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.	24 hours, 7 days, 30±3 days, 90±3 days
Other	Numeric rating scales (NRS) score during intervention.	Numeric rating scales (NRS) score during intervention. Ranged from 0 to 10, a low value represents a less pain.	7 days
Other	The number of early withdrawal for safety or tolerability reasons	The number of early withdrawal for safety or tolerability reasons	7 days
Primary	Proportion of patients with Modified Rankin Scale (mRS) Score 0-1	Proportion of patients with Modified Rankin Scale (mRS) Score 0-1. Ranged from 0 to 6, a low value represents a better outcome.	3 months
Secondary	National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.	National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days after IVT. Ranged from 0 to 42, a low value represents a better outcome.	24 hours, 7 days, 30±3 days, 90±3 days
Secondary	Barthel Index (BI) at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.	Barthel Index (BI) at 24 hours, 7 days, 30±3 days, 90±3 days after IVT. Ranged from 0 to 100, a high value represents a better outcome.	24 hours, 7 days, 30±3 days, 90±3 days
Secondary	modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.	modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days after IVT. Ranged from 0 to 6, a low value represents a better outcome.	24 hours, 7 days, 30±3 days, 90±3 days
Secondary	Proportion of patients with modified Rankin Scale (mRS) Score 0-2, NIHSS score 0-1, Barthel Index (BI) =95 at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.	Proportion of patients with modified Rankin Scale (mRS) Score 0-2, NIHSS score 0-1, Barthel Index (BI) =95 at 24 hours, 7 days, 30±3 days, 90±3 days after IVT. mRS: Ranged from 0 to 100, a high value represents a better outcome. NIHSS: Ranged from 0 to 42, a low value represents a better outcome. BI: Ranged from 0 to 100, a high value represents a better outcome.	24 hours, 7 days, 30±3 days, 90±3 days
Secondary	Frequency of adverse events during follow-up	Severe adverse events through day-90 after the onset of acute ischemic stroke.	90 days
Secondary	Frequency of Hemorrhagic transformation during hospitalization	Frequency of Hemorrhagic transformation during hospitalization	7 days