Aneurysm Clinical Trial
— NEATOfficial title:
The Neuroprotective Effect of Remote Ischemic Conditioning in Aneurysm Coiling
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.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | January 1, 2019 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Xuanwu Hospital, Capital Medical University | Beijing | Beijing |
China | Shengli Oilfield Center Hospital | Dongying | Shandong |
China | Nanyang City Center Hospital | Nanyang | |
China | Suzhou Municipal Hoapital | Suzhou | An Hui |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | |
China | The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Capital Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Occurrence of adverse events and serious adverse events | Occurrence of adverse events and serious adverse events | 30 days | |
Primary | The presence of =1 new brain lesions on DWI | Assessed by DWI | within 72 hours after endovascular treatment | |
Secondary | Number of new ischemic lesions | within 72 hours after endovascular treatment | ||
Secondary | Volume of new ischemic lesions | within 72 hours after endovascular treatment | ||
Secondary | 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 | |
Secondary | Cerebrovascular events | Cerebrovascular events included ischemic stroke, hemorrhagic stroke, and TIA. | 30 days | |
Secondary | 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 | 30 days | |
Secondary | Modified Rankin Scale | Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death). | 30 days |
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