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Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Ischemic Stroke (SERIC-AIS)

Primary Purpose

Acute Ischemic Stroke

Status

Not yet 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 - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1）Age≥18 years, < 80 years, regardless of sex；
2）Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 12 hours of stroke onset
3）Baseline NIHSS score>5, and≤25 ；
4）GCS score ≥8；
5）Signed and dated informed consent is obtained

Exclusion Criteria:

1) Patients with suspected posterior circulation infarction；
2) Patients who undergo thrombolytic therapy or endovascular treatment；
3) mRS≥2 score before the onset of the disease；
4) Double upper limbs or lower limbs paralysis was found in this case；
5）Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on；
6) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain；
7) Treated blood pressure ≤90mmHg/60mmHg or≥180mmHg/100mmHg；
8) Severe organ dysfunction or failure；
9) Persons suffering from severe hematological diseases or severe coagulation disorder dysfunction；
10) Those who had a history of severe trauma or had major surgery within 6 months prior to admission；
11) 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；
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.

Sites / Locations

First Hospital of Jilin University

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 inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days. Additionally,the patients will be treated with standard medical treatment according to 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 inflations of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 days. Additionally,the patients will be treated with standard medical treatment according to 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

The primary outcome measure of efficacy is the modified Rankin Scale (mRS) dichotomized to define good functional outcome as mRS 0-2 at 90 days.score, dichotomized to define good functional outcome as mRS 0-2 at 90 days.

Secondary Outcome Measures

NIHSS Score at end of 7th day of treatment

mRS Score at end of 7th day of treatment

Barthel Index at end of 7th day of treatment

Changes of hematological indicators

The changes of hematological indicators (inflammatory cytokine,et al.) between the first 48h and end of 7th day of treatment.

Full Information

NCT ID

NCT03669653

First Posted

August 27, 2018

Last Updated

October 31, 2022

Sponsor

Yi Yang

1. Study Identification

Unique Protocol Identification Number

NCT03669653

Brief Title

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Ischemic Stroke

Acronym

SERIC-AIS

Official Title

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Ischemic Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 17, 2023 (Anticipated)

Primary Completion Date

September 20, 2024 (Anticipated)

Study Completion Date

September 20, 2025 (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

he purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for acute ischemic stroke.

Detailed Description

In this study, 912 cases of ischemic stroke in 48 hours were included in 5 centers in China according to the principle of random, double-blind 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, 7 days in a row . Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning therapy.

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

912 (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 inflations of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 days. Additionally,the patients will be treated with standard medical treatment according to 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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

NIHSS Score at end of 7th day of treatment

Description

NIHSS Score at end of 7th day of treatment

Time Frame

7 days

Title

mRS Score at end of 7th day of treatment

Description

mRS Score at end of 7th day of treatment

Time Frame

7 days

Title

Barthel Index at end of 7th day of treatment

Description

Barthel Index at end of 7th day of treatment

Time Frame

7 days

Title

Changes of hematological indicators

Description

The changes of hematological indicators (inflammatory cytokine,et al.) between the first 48h and end of 7th day of treatment.

Time Frame

48h; 7days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1）Age≥18 years, < 80 years, regardless of sex； 2）Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 12 hours of stroke onset 3）Baseline NIHSS score>5, and≤25 ； 4）GCS score ≥8； 5）Signed and dated informed consent is obtained Exclusion Criteria: 1) Patients with suspected posterior circulation infarction； 2) Patients who undergo thrombolytic therapy or endovascular treatment； 3) mRS≥2 score before the onset of the disease； 4) Double upper limbs or lower limbs paralysis was found in this case； 5）Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on； 6) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain； 7) Treated blood pressure ≤90mmHg/60mmHg or≥180mmHg/100mmHg； 8) Severe organ dysfunction or failure； 9) Persons suffering from severe hematological diseases or severe coagulation disorder dysfunction； 10) Those who had a history of severe trauma or had major surgery within 6 months prior to admission； 11) 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； 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.

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

Zhen-Ni Guo, MD

zhen1ni2@163.com

Facility Information:

Facility Name

First Hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130000

Country

China

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 in Patients With Acute Ischemic Stroke

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