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The Neuroprotective Effect of Remote Ischemic Conditioning in Aneurysm Coiling Therapy (NEAT)

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ClinicalTrials.gov Identifier: NCT03496415
Recruitment Status : Unknown
Verified November 2018 by Ji Xunming,MD,PhD, Capital Medical University.
Recruitment status was:  Recruiting
First Posted : April 12, 2018
Last Update Posted : November 23, 2018
Sponsor:
Information provided by (Responsible Party):
Ji Xunming,MD,PhD, Capital Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aneurysm Device: remote ischemic conditioning Device: sham remote ischemic conditioning Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Neuroprotective Effect of Remote Ischemic Conditioning in Aneurysm Coiling
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arms and Interventions
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Arm Intervention/treatment
Experimental: Remote ischemic conditioning Device: 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 Comparator: Sham remote ischemic conditioning Device: 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


Outcome Measures
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Primary Outcome Measures :
  1. The presence of ≥1 new brain lesions on DWI [ Time Frame: within 72 hours after endovascular treatment ]
    Assessed by DWI


Secondary Outcome Measures :
  1. Number of new ischemic lesions [ Time Frame: within 72 hours after endovascular treatment ]
  2. Volume of new ischemic lesions [ Time Frame: within 72 hours after endovascular treatment ]
  3. National Institutes of Health Stroke Scale [ Time Frame: 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.

  4. Cerebrovascular events [ Time Frame: 30 days ]
    Cerebrovascular events included ischemic stroke, hemorrhagic stroke, and TIA.

  5. Nondisabling events [ Time Frame: 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

  6. Modified Rankin Scale [ Time Frame: 30 days ]
    Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).


Other Outcome Measures:
  1. Occurrence of adverse events and serious adverse events [ Time Frame: 30 days ]
    Occurrence of adverse events and serious adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496415


Contacts
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Contact: Xunming Ji, MD 008601083198930 jixm@ccmu.edu.cn

Locations
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China, An Hui
Suzhou Municipal Hoapital Recruiting
Suzhou, An Hui, China
Contact: Zhengfei Ma, MD         
China, Beijing
Xuanwu Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100053
Contact: Xunming Ji         
Principal Investigator: Xunming Ji         
China, Henan
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine Not yet recruiting
Zhengzhou, Henan, China
Contact: Dongsheng Guan         
China, Shandong
Shengli Oilfield Center Hospital Recruiting
Dongying, Shandong, China, 257034
Contact: Zongen Gao, MD    8613854669979    gaozongen@126.com   
Contact: Tianping Tang, MD    8618678662921    18678662921@163.com   
China
Nanyang City Center Hospital Recruiting
Nanyang, China
Contact: Changming Wen         
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, China
Contact: Yajun Lian         
Sponsors and Collaborators
Capital Medical University
More Information
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Responsible Party: Ji Xunming,MD,PhD, MD, Capital Medical University
ClinicalTrials.gov Identifier: NCT03496415    
Other Study ID Numbers: 2017-NEAT
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Vascular Diseases
Cardiovascular Diseases