Back to resultsEffect of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients After Intravenous Thrombolysis (RICCH-IVT)
Primary Purpose
Remote Ischemic Conditioning
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sham remote ischemic conditioning
Sponsored by
About this trial
This is an interventional treatment trial for Remote Ischemic Conditioning focused on measuring Remote Ischemic Conditioning, Intravenous Thrombolysis, Cerebral Hemodynamics, Cerebral Autoregulation, Cerebral Blood Flow Velocity
Eligibility Criteria
Inclusion Criteria:
- age ≥ 18 and < 80 years, both sexes;
- a clear clinical diagnosis of acute ischemic stroke and treatment with standard rt-PA (0.9 mg/kg) IVT within 4.5 h of stroke onset;
- pre-onset modified Rankin Scale (mRS) score ≤1;
- baseline National Institute of Health Stroke Scale (NIHSS) score ≥5 and ≤25;
- Glasgow Coma Scale score ≥8.
Exclusion Criteria:
- having received bridging therapy (IVT plus mechanical thrombectomy);
- previous history of atrial fibrillation or electrocardiographic evidence of atrial fibrillation;
- contraindications to RIC treatment or previous RIC treatment or similar treatment;
- pregnancy or breastfeeding;
- life expectancy of ≤3 months or inability to complete the study for other reasons;
- unwillingness to be followed up or poor treatment compliance or participation in other clinical studies;
- had insufficient bilateral temporal bone windows for insonation of the middle cerebral artery.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
RIC group
Sham-RIC group
Arm 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. RIC will be conducted at 6 and 18-24 hours after intravenous thrombolysis.
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 at 6 and 18-24 hours after intravenous thrombolysis.
Outcomes
Primary Outcome Measures
Cerebral autoregulation parameter
Cerebral autoregulation 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 parameter.
Secondary Outcome Measures
Cerebral blood flow velocity
Cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05598658
Brief Title
Effect of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients After Intravenous Thrombolysis (RICCH-IVT)
Official Title
Effect of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients After Intravenous Thrombolysis (RICCH-IVT)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 30, 2023 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
September 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 effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis
Detailed Description
In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The RIC group receive basic treatment and remote ischemic conditioning for 200mmHg at 6 and 18-24 hours after intravenous thrombolysis. The sham-RIC group receive basic treatment and remote ischemic conditioning for 60mmHg at 6 and 18-24 hours after intravenous thrombolysis. Both groups underwent cerebral hemodynamics after RIC and recorded the relevant indexes. The investigators aimed to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Remote Ischemic Conditioning
Keywords
Remote Ischemic Conditioning, Intravenous Thrombolysis, Cerebral Hemodynamics, Cerebral Autoregulation, Cerebral Blood Flow Velocity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RIC group
Arm Type
Active Comparator
Arm 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. RIC will be conducted at 6 and 18-24 hours after intravenous thrombolysis.
Arm Title
Sham-RIC group
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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted at 6 and 18-24 hours after intravenous thrombolysis.
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
Cerebral autoregulation parameter
Description
Cerebral autoregulation 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 parameter.
Time Frame
1-10 days
Secondary Outcome Measure Information:
Title
Cerebral blood flow velocity
Description
Cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler.
Time Frame
1-10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥ 18 and < 80 years, both sexes;
a clear clinical diagnosis of acute ischemic stroke and treatment with standard rt-PA (0.9 mg/kg) IVT within 4.5 h of stroke onset;
pre-onset modified Rankin Scale (mRS) score ≤1;
baseline National Institute of Health Stroke Scale (NIHSS) score ≥5 and ≤25;
Glasgow Coma Scale score ≥8.
Exclusion Criteria:
having received bridging therapy (IVT plus mechanical thrombectomy);
previous history of atrial fibrillation or electrocardiographic evidence of atrial fibrillation;
contraindications to RIC treatment or previous RIC treatment or similar treatment;
pregnancy or breastfeeding;
life expectancy of ≤3 months or inability to complete the study for other reasons;
unwillingness to be followed up or poor treatment compliance or participation in other clinical studies;
had insufficient bilateral temporal bone windows for insonation of the middle cerebral artery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Yang, MD,PhD
Phone
0086-13756661217
Email
doctoryangyi@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenni Guo, MD,PhD
Email
zhen1ni2@163.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients After Intravenous Thrombolysis (RICCH-IVT)
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