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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aneurysm | Device: remote ischemic conditioning Device: sham remote ischemic conditioning | Phase 2 Phase 3 |
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 |
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 |
- The presence of ≥1 new brain lesions on DWI [ Time Frame: within 72 hours after endovascular treatment ]Assessed by DWI
- Number of new ischemic lesions [ Time Frame: within 72 hours after endovascular treatment ]
- Volume of new ischemic lesions [ Time Frame: within 72 hours after endovascular treatment ]
- 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.
- Cerebrovascular events [ Time Frame: 30 days ]Cerebrovascular events included ischemic stroke, hemorrhagic stroke, and TIA.
- 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
- Modified Rankin Scale [ Time Frame: 30 days ]Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).
- Occurrence of adverse events and serious adverse events [ Time Frame: 30 days ]Occurrence of adverse events and serious adverse events

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

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
Contact: Xunming Ji, MD | 008601083198930 | jixm@ccmu.edu.cn |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Aneurysm Vascular Diseases Cardiovascular Diseases |