The Neuroprotective Effect of Remote Ischemic Conditioning in Ruptured Aneurysm Coiling Therapy

Study Overview
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Brief Summary
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The overall incidence of DWI positive for thromboembolic events following endovascular treatment of intracranial aneurysms is proximately 50%. Whether remote ischemic conditioning was safe and effective to reduce ischemic brain lesions on DWI after endovascular treatment of intracranial aneurysms is still unclear. The investigators' hypothesis is that remote ischemic conditioning is a safe and effective strategy to reduce new ischemic lesions in intracranial aneurysms patients undergoing endovascular treatment.

Official Title
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The Neuroprotective Effect of Remote Ischemic Conditioning in Ruptured Aneurysm Coiling Therapy

Conditions
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Aneurysm, Ruptured, Coiling Therapy

Intervention / Treatment
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* Device: remote ischemic conditioning
* Device: sham remote ischemic conditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Ruptured brain aneurysm deemed suitable for neuroendovascular repair Normal baseline brain MRI Female subjects of childbearing potential have a negative pregnancy test. Signed informed consent prior to entering study Exclusion Criteria: Dissecting or mycotic brain aneurysm. Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment Renal insufficiency with creatinine ≥ 265 umol/L Severe, sustained hypertension (SBP > 185 mmHg or DBP > 110 mmHg) Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs Pre-morbid modified Rankin scale score of greater than 1 Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations Patients who are unable to have an MRI scan for any reason. Currently participating or previously participated in any investigational drug or device study within 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote ischemic conditioning group<br> | Device: remote ischemic conditioning<br>* Remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mm Hg during the ischemic period (Patent No. CN200820123637.X, China)<br>|
| Sham Comparator: Sham remote ischemic conditioning group<br> | Device: sham remote ischemic conditioning<br>* Sham remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 60 mm Hg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of ≥1 new brain lesions on DWI | Assessed by DWI | within 72 hours after endovascular treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of new ischemic lesions |  | within 72 hours after endovascular treatment | 
| Volume of new ischemic lesions |  | within 72 hours after endovascular treatment | 
| National Institutes of Health Stroke Scale | Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits. | 7 days or discharge | 
| Composite of Cerebrovascular events | This is a composited endpoint.Cerebrovascular events included ischemic stroke, hemorrhagic stroke, and TIA. The present subarachnoid hemorrhage isn't included. | 30 days | 
| Nondisabling events | Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.National Institutes of Health Stroke Scale ≤3 or TIA is defined as nondisabling events The present subarachnoid hemorrhage isn't included. | 30 days | 
| Modified Rankin Scale | Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death). | 30 days |