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

Primary Purpose

Acute Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sham remote ischemic conditioning
Sponsored by
Yi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

RIC+Standard medical treatment

Sham RIC+Standard medical treatment

Arm Description

RIC+Standard medical treatment 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 inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days from thrombolysis. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.

Sham RIC+Standard medical treatment 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 inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days from thrombolysis. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Frequency of adverse events during follow-up
Severe adverse events through day-90 after the onset of acute ischemic stroke.
Frequency of Hemorrhagic transformation during hospitalization
Frequency of Hemorrhagic transformation during hospitalization

Full Information

First Posted
July 13, 2021
Last Updated
October 31, 2022
Sponsor
Yi Yang
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1. Study Identification

Unique Protocol Identification Number
NCT04980625
Brief Title
Safety and Efficacy of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
Official Title
Safety and Efficacy of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke: A Multicenter, Randomized, Parallel-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yi Yang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
558 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIC+Standard medical treatment
Arm Type
Active Comparator
Arm Description
RIC+Standard medical treatment 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 inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days from thrombolysis. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.
Arm Title
Sham RIC+Standard medical treatment
Arm Type
Placebo Comparator
Arm Description
Sham RIC+Standard medical treatment 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 inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days from thrombolysis. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic conditioning
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham remote ischemic conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients with Modified Rankin Scale (mRS) Score 0-1
Description
Proportion of patients with Modified Rankin Scale (mRS) Score 0-1. Ranged from 0 to 6, a low value represents a better outcome.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.
Description
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.
Time Frame
24 hours, 7 days, 30±3 days, 90±3 days
Title
Barthel Index (BI) at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.
Description
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.
Time Frame
24 hours, 7 days, 30±3 days, 90±3 days
Title
modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.
Description
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.
Time Frame
24 hours, 7 days, 30±3 days, 90±3 days
Title
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.
Description
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.
Time Frame
24 hours, 7 days, 30±3 days, 90±3 days
Title
Frequency of adverse events during follow-up
Description
Severe adverse events through day-90 after the onset of acute ischemic stroke.
Time Frame
90 days
Title
Frequency of Hemorrhagic transformation during hospitalization
Description
Frequency of Hemorrhagic transformation during hospitalization
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.
Description
Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.
Time Frame
24 hours, 7 days, 30±3 days, 90±3 days
Title
heart rate at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.
Description
heart rate at 24 hours, 7 days, 30±3 days, 90±3 days after IVT.
Time Frame
24 hours, 7 days, 30±3 days, 90±3 days
Title
Numeric rating scales (NRS) score during intervention.
Description
Numeric rating scales (NRS) score during intervention. Ranged from 0 to 10, a low value represents a less pain.
Time Frame
7 days
Title
The number of early withdrawal for safety or tolerability reasons
Description
The number of early withdrawal for safety or tolerability reasons
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Yang, MD, PhD
Phone
0086-13756661217
Email
doctor_yangyi@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenni Guo, MD, PhD
Email
zhen1ni2@163.com
Facility Information:
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Yang, MD, PhD
Email
doctor_yangyi@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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