The Neuroprotective Effect of Remote Ischemic Conditioning in Aneurysm Coiling Therapy
NCT ID: NCT03496415
Last Updated: 2018-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
210 participants
INTERVENTIONAL
2018-05-03
2019-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Remote ischemic conditioning
remote 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)
Sham remote ischemic conditioning
sham 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
Interventions
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remote 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)
sham 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Ji Xunming,MD,PhD
MD
Locations
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Suzhou Municipal Hoapital
Suzhou, Anhui, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China
Shengli Oilfield Center Hospital
Dongying, Shandong, China
Nanyang City Center Hospital
Nanyang, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Zhengfei Ma, MD
Role: primary
Xunming Ji
Role: primary
Dongsheng Guan
Role: primary
Changming Wen
Role: primary
Yajun Lian
Role: primary
Other Identifiers
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2017-NEAT
Identifier Type: -
Identifier Source: org_study_id
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