Back to resultsDynamic Cerebral Autoregulation of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (CARIC-IVT)
Primary Purpose
Remote Ischemic Conditioning
Status
Completed
Phase
Not Applicable
Locations
China
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, Dynamic Cerebral Autoregulation
Eligibility Criteria
Inclusion Criteria:
- Age≥18 years, < 80 years, regardless of sex;
- Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
- Baseline NIHSS >= 5, and <= 25;
- Baseline GCS ≥8;
- Signed and dated informed consent is obtained
Exclusion Criteria:
- Patients who undergo endovascular treatment;
- mRS ≥ 2 before the onset of the disease;
- Severe organ dysfunction or failure;
- Those who have a history of atrial fibrillation;
- 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;
- Pregnant or lactating women;
- Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
- 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;
- 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 mmHg. RIC will be conducted twice within 6 to 24 hours 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg. RIC will be conducted twice twice within 6 to 24 hours from thrombolysis.
Outcomes
Primary Outcome Measures
Dynamic cerebral autoregulation of affected sides measured by phase difference(PD) in Degree
A dynamic cerebral auto-regulation parameter 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
Dynamic cerebral autoregulation of unaffected sides measured by phase difference(PD) in Degree
A dynamic cerebral auto-regulation parameter 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.
Dynamic cerebral autoregulation of affected sides measured by phase difference(PD) in Degree
A dynamic cerebral auto-regulation parameter 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.
Dynamic cerebral autoregulation of unaffected sides measured by phase difference(PD) in Degree
A dynamic cerebral auto-regulation parameter 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.
Hematology related indicators
Blood samples were collected before and 24 hours after intravenous thrombolysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05125861
Brief Title
Dynamic Cerebral Autoregulation of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
Acronym
CARIC-IVT
Official Title
Dynamic Cerebral Autoregulation of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
November 4, 2021 (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
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 impact of remote ischemic conditioning on dynamic cerebral autoregulation in patients with acute ischemic stroke receiving intravenous thrombolysis.
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 . Both groups underwent dynamic cerebral autoregulation measurements at days 1 to 2 and 7 to 10 of onset and recorded the relevant indexes, and blood samples were collected before and 24 hours after intravenous thrombolysis, we aimed to determine the impact of remote ischemic conditioning combined with intravenous thrombolysis on dynamic cerebral autoregulation in acute ischemic stroke patients. We hypothesized that remote ischemic conditioning would improve dynamic cerebral autoregulation in patients with acute ischemic stroke receiving 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, Dynamic Cerebral Autoregulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RIC group
Arm Type
Active Comparator
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 mmHg. RIC will be conducted twice within 6 to 24 hours from thrombolysis.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
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 mmHg. RIC will be conducted twice twice within 6 to 24 hours from 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg. All patients underwent dynamic cerebral autoregulation on days 1-2 and 7-10 after onset, and intravenous blood was collected by a nurse and stored in the laboratory 0-6 hours after thrombolysis and 24 hours after thrombolysis.
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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg. All patients underwent dynamic cerebral autoregulation on days 1-2 and 7-10 after onset, and intravenous blood was collected by a nurse and stored in the laboratory 0-6 hours after thrombolysis and 24 hours after thrombolysis.
Primary Outcome Measure Information:
Title
Dynamic cerebral autoregulation of affected sides measured by phase difference(PD) in Degree
Description
A dynamic cerebral auto-regulation parameter 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.
Time Frame
1-2 days
Secondary Outcome Measure Information:
Title
Dynamic cerebral autoregulation of unaffected sides measured by phase difference(PD) in Degree
Description
A dynamic cerebral auto-regulation parameter 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.
Time Frame
1-2 days
Title
Dynamic cerebral autoregulation of affected sides measured by phase difference(PD) in Degree
Description
A dynamic cerebral auto-regulation parameter 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.
Time Frame
7-10 days
Title
Dynamic cerebral autoregulation of unaffected sides measured by phase difference(PD) in Degree
Description
A dynamic cerebral auto-regulation parameter 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.
Time Frame
7-10 days
Title
Hematology related indicators
Description
Blood samples were collected before and 24 hours after intravenous thrombolysis
Time Frame
before and 24 hours after intravenous thrombolysis
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 years, < 80 years, regardless of sex;
Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
Baseline NIHSS >= 5, and <= 25;
Baseline GCS ≥8;
Signed and dated informed consent is obtained
Exclusion Criteria:
Patients who undergo endovascular treatment;
mRS ≥ 2 before the onset of the disease;
Severe organ dysfunction or failure;
Those who have a history of atrial fibrillation;
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;
Pregnant or lactating women;
Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
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;
Other conditions that the researchers think are not suitable for the group.
Facility Information:
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Dynamic Cerebral Autoregulation of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
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