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Safety and Efficacy of Remote Ischemic Conditioning 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

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 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.

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

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. 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.

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. 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 0-2.

Proportion of patients with modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.

Secondary Outcome Measures

National Institute of Health stroke scale (NIHSS) at 7 days, 30±3 days, 90±3 days from onset.

National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 42, a low value represents a better outcome.

modified Rankin Scale (mRS) Score at 7 days, 30±3 days, 90±3 days from onset.

modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 6, a low value represents a better outcome.

Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset.

Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 100, a high value represents a better outcome.

Proportion of patients with hemorrhagic transformation during hospitalization.

Frequency of adverse events during follow-up.

Severe adverse events through day-90 after the onset of acute ischemic stroke.

Full Information

NCT ID

NCT04980651

First Posted

July 13, 2021

Last Updated

October 31, 2022

Sponsor

Yi Yang

1. Study Identification

Unique Protocol Identification Number

NCT04980651

Brief Title

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

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

October 1, 2024 (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

Studies a U.S. FDA-regulated Device Product

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 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.

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

2210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RIC+Standard medical treatment

Arm Type

Active Comparator

Arm Description

Arm Title

Sham RIC+Standard medical treatment

Arm Type

Placebo Comparator

Arm 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 inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days. 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

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 inflation of a blood pressure cuff to 60 mm Hg.

Primary Outcome Measure Information:

Title

Proportion of patients with modified Rankin Scale (mRS) Score 0-2.

Description

Proportion of patients with modified Rankin Scale (mRS) Score 0-2. 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 7 days, 30±3 days, 90±3 days from onset.

Description

National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 42, a low value represents a better outcome.

Time Frame

7days, 30±3 days, 90±3 days

Title

modified Rankin Scale (mRS) Score at 7 days, 30±3 days, 90±3 days from onset.

Description

modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 6, a low value represents a better outcome.

Time Frame

7days, 30±3 days, 90±3 days

Title

Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset.

Description

Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 100, a high value represents a better outcome.

Time Frame

7days, 30±3 days, 90±3 days

Title

Proportion of patients with hemorrhagic transformation during hospitalization.

Description

Proportion of patients with hemorrhagic transformation during hospitalization.

Time Frame

7 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

Other Pre-specified Outcome Measures:

Title

Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days.

Description

Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days.

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.

Description

heart rate at 24 hours, 7 days, 30±3 days, 90±3 days.

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

Proportion of patients with early withdrawal for safety or tolerability reasons.

Description

Proportion of patients with 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

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yi Yang, MD, PhD

Phone

0086-13756661217

doctor_yangyi@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhenni Guo, MD, PhD

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

doctor_yangyi@163.com

12. IPD Sharing Statement

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Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke

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