Aneurysm
Conditions
Brief summary
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.
Interventions
DEVICEremote ischemic conditioning
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)
DEVICEsham remote ischemic conditioning
sham remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 60 mm Hg
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Unruptured 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The presence of ≥1 new brain lesions on DWI | within 72 hours after endovascular treatment | Assessed by DWI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 7 days or discharge | Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits. |
| Nondisabling events | 30 days | 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 |
| Modified Rankin Scale | 30 days | Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death). |
| Cerebrovascular events | 30 days | Cerebrovascular events included ischemic stroke, hemorrhagic stroke, and TIA. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of adverse events and serious adverse events | 30 days | Occurrence of adverse events and serious adverse events |
Countries
China
Contacts
Primary ContactXunming Ji, MD
Outcome results
None listed