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Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke (SERICT-AIS)

Primary Purpose

Acute Ischemic Stroke

Status

Completed

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 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.

Sites / Locations

The First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

RIC group

control group

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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice twice within 6 to 24 hours from thrombolysis. 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

Frequency of adverse events during hospitalization

All adverse events until day-7 or discharge (whichever is earlier)

Frequency of adverse events during follow-up

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

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04027621

First Posted

July 14, 2019

Last Updated

June 27, 2022

Sponsor

Yi Yang

1. Study Identification

Unique Protocol Identification Number

NCT04027621

Brief Title

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

Acronym

SERICT-AIS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

July 1, 2020 (Actual)

Study Completion Date

July 20, 2020 (Actual)

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 combined with intravenous thrombolysis in treating acute ischemic stroke.

Detailed 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.

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

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RIC group

Arm Type

Active Comparator

Arm Description

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.

Intervention Type

Device

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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.

Primary Outcome Measure Information:

Title

Frequency of adverse events during hospitalization

Description

All adverse events until day-7 or discharge (whichever is earlier)

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

3 months

Secondary Outcome Measure Information:

Title

National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge

Description

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.

Time Frame

7 days

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

Other Pre-specified Outcome Measures:

Title

Changes of hematological indicators

Description

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.

Time Frame

24 hours

Title

Changes of the function of dynamic cerebral autoregulation

Description

The function of patients' dynamic cerebral autoregulation are tested 3 times within 10 days from onset and compared between the two groups.

Time Frame

10 days

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 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.

Facility Information:

Facility Name

The First Hospital of Jilin University

City

Chang chun

State/Province

Jilin

ZIP/Postal Code

130000

Country

China

12. IPD Sharing Statement

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

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