CARIC-IVT: Dynamic Cerebral Autoregulation of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the impact of remote ischemic conditioning on dynamic cerebral autoregulation and related hematology indexes in patients with acute ischemic stroke receiving intravenous thrombolysis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 at days 1 to 2, 4 to 6, and 7 to 10 of onset, and recorded the relevant indexes， 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: RIC group 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. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014. Within 24 hours after IVT, the patient was given nerve nutrition and lipid stabilization treatment. 24 hours after IVT, the patient was given the appropriate treatment, including anti-platelet aggregation and circulation improvement drugs, according to the results of the rechecked head CT. |
Procedure: remote ischemic conditioning
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, 3-4, 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.
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| Placebo Comparator: control group 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. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014. Within 24 hours after IVT, the patient was given nerve nutrition and lipid stabilization treatment. 24 hours after IVT, the patient was given the appropriate treatment, including anti-platelet aggregation and circulation improvement drugs, according to the results of the rechecked head CT. |
Procedure: sham remote ischemic conditioning
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, 3-4, 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.
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Outcome Measures
Primary Outcome Measures
- Dynamic cerebral autoregulation parameter: Phase Difference(PD) in Degree [1-2 days, 4-6 days, 7-10 days]
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. The results of dynamic brain autoregulation were recorded 1-2 days, 4-6 days and 7-10 days after the onset of the disease.
- Dynamic cerebral autoregulation parameter: Gain in cm/s/mmHg [1-2 days, 4-6 days, 7-10 days]
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. The results of dynamic brain autoregulation were recorded 1-2 days, 4-6 days and 7-10 days after the onset of the disease.
Secondary Outcome Measures
- Hematology related indicators [0-6 hours, 24hours]
Detection of relevant blood samples taken 0-6 hours and 24 hours after intravenous thrombolysis.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age≥18 years, < 80 years, regardless of sex;
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Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
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Baseline NIHSS >= 5, and <= 25;
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Baseline GCS ≥8;
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Signed and dated informed consent is obtained
Exclusion Criteria:
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Patients who undergo endovascular treatment;
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mRS ≥ 2 before the onset of the disease;
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Double upper limbs or lower limbs paralysis was found in this case;
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Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on;
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Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain;
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Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
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Severe organ dysfunction or failure;
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Patients suffering from severe hematological diseases or severe coagulation disorder dysfunction
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Those who have a history of severe trauma or had major surgery within 6 months prior to admission;
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Those who have a history of atrial fibrillation;
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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;
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Pregnant or lactating women;
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Previous remote ischemic conditioning therapy or similar treatment;
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Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
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Severe hepatic and renal dysfunction;
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Unwilling to be followed up or treated for poor compliance;
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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;
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Other conditions that the researchers think are not suitable for the group.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Hospital of Jilin University | Changchun | Jilin | China | 130000 |
Sponsors and Collaborators
- Yi Yang
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CARIC-IVT