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Effect of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Patients With Intravenous Thrombolysis (SRICDCA-IVT) (SRICDCA-IVT)

Primary Purpose

Acute Ischemic Stroke

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Remote ischemic conditioning

Sham remote ischemic conditioning

Standard medical treatment

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 undergo intravenous thrombolysis with alteplase in 4.5 hours;
3) Baseline mRs 2-5; and Premorbid mRS ≤ 1；
4) Baseline NIHSS>= 4, and <= 24;
5) Signed and dated informed consent is obtained;

Exclusion Criteria:

1) Patients who have the contraindication of intravenous thrombolysis with alteplase;
2) Patients with consciousness disorder or restlessness who cannot cooperate with dynamic cerebral autoregulation;
3) Patients whose stable cerebral blood flow velocity envelope cannot be obtained by transcranial Doppler ultrasound or whose cerevral blood vessels have not been detected;
4) 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;
5) Pregnant or lactating women;
6) Previous remote ischemic conditioning therapy or similar treatment;
7) Laboratory indicators are not qualified: Alanine transaminase (ALT) or glutamic-oxalacetic transaminase (AST) continued to rise more than 3 times the upper limit of normal, Serum creatinine > 265 umol/l (> 3.0 mg/dl);
8) Previous history of atrial fibrillation or ECG showing atrial fibrillation or arrhythmia;
9) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
10) Unwilling to be followed up or treated for poor compliance;
11) 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;
12) 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.

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.

Outcomes

Primary Outcome Measures

Dynamic cerebral autoregulation parameter

Dynamic cerebral auto-regulation parameters derived from transfer function analysis. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.

Secondary Outcome Measures

National Institute of Health stroke scale (NIHSS)

National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.

modified Rankin Scale (mRS)

modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

Full Information

NCT ID

NCT05550103

First Posted

September 19, 2022

Last Updated

October 25, 2022

Sponsor

Yi Yang

1. Study Identification

Unique Protocol Identification Number

NCT05550103

Brief Title

Effect of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Patients With Intravenous Thrombolysis (SRICDCA-IVT)

Acronym

SRICDCA-IVT

Official Title

Effect of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Patients With Intravenous Thrombolysis (SRICDCA-IVT)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

February 1, 2023 (Anticipated)

Study Completion Date

May 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

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 effect of serial remote ischemic conditioning on dynamic cerebral autoregulation in patients with intravenous thrombolysis with alteplase.

Detailed Description

In this study, cases of ischemic stroke who undergo intravenous thrombolysis with alteplase within 4.5 hours from the onset are included 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. Both groups underwent dynamic cerebral autoregulation measurements at days 1,3,and 7 of onset and recorded the relevant indexes. We aimed to determine the effect of serial remote ischemic conditioning on dynamic cerebral autoregulation in patients with intravenous thrombolysis with alteplase.

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

60 (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

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.

Intervention Type

Other

Intervention Name(s)

Standard medical treatment

Intervention Description

Standard medical treatment

Primary Outcome Measure Information:

Title

Dynamic cerebral autoregulation parameter

Description

Time Frame

0-7 days

Secondary Outcome Measure Information:

Title

National Institute of Health stroke scale (NIHSS)

Description

National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.

Time Frame

0-7 days

Title

modified Rankin Scale (mRS)

Description

modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

Time Frame

0-90 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 undergo intravenous thrombolysis with alteplase in 4.5 hours; 3) Baseline mRs 2-5; and Premorbid mRS ≤ 1； 4) Baseline NIHSS>= 4, and <= 24; 5) Signed and dated informed consent is obtained; Exclusion Criteria: 1) Patients who have the contraindication of intravenous thrombolysis with alteplase; 2) Patients with consciousness disorder or restlessness who cannot cooperate with dynamic cerebral autoregulation; 3) Patients whose stable cerebral blood flow velocity envelope cannot be obtained by transcranial Doppler ultrasound or whose cerevral blood vessels have not been detected; 4) 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; 5) Pregnant or lactating women; 6) Previous remote ischemic conditioning therapy or similar treatment; 7) Laboratory indicators are not qualified: Alanine transaminase (ALT) or glutamic-oxalacetic transaminase (AST) continued to rise more than 3 times the upper limit of normal, Serum creatinine > 265 umol/l (> 3.0 mg/dl); 8) Previous history of atrial fibrillation or ECG showing atrial fibrillation or arrhythmia; 9) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons; 10) Unwilling to be followed up or treated for poor compliance; 11) 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; 12) 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

doctoryangyi@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

doctoryangyi@163.com

12. IPD Sharing Statement

Learn more about this trial

Effect of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Patients With Intravenous Thrombolysis (SRICDCA-IVT)

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