NEAT-2: The Neuroprotective Effect of Remote Ischemic Conditioning in Ruptured Aneurysm Coiling Therapy

• Sponsor: Capital Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03561311
• Collaborator: (none)
• Enrollment: 210
• Locations: 5
• Arms: 2
• Anticipated Duration (Months): 8.8
• Patients Per Site: 42
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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, Ruptured; Coiling Therapy	Device: remote ischemic conditioning; Device: sham remote ischemic conditioning	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Neuroprotective Effect of Remote Ischemic Conditioning in Ruptured Aneurysm Coiling Therapy
• Actual Study Start Date: Oct 6, 2018
• Anticipated Primary Completion Date: May 31, 2019
• Anticipated Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remote ischemic conditioning group	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 group	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

Primary Outcome Measures

1. The presence of ≥1 new brain lesions on DWI [within 72 hours after endovascular treatment]

   Assessed by DWI

Secondary Outcome Measures

1. Number of new ischemic lesions [within 72 hours after endovascular treatment]

2. Volume of new ischemic lesions [within 72 hours after endovascular treatment]

3. 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.

4. Composite of Cerebrovascular events [30 days]

   This is a composited endpoint.Cerebrovascular events included ischemic stroke, hemorrhagic stroke, and TIA. The present subarachnoid hemorrhage isn't included.

5. 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 The present subarachnoid hemorrhage isn't included.

6. Modified Rankin Scale [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 [30 days]

   Occurrence of adverse events and serious adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 years or older

• Ruptured 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

• Renal insufficiency with creatinine ≥ 265 umol/L

• 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

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu Hospital, Capital Medical University	Beijing	Beijing	China	100053
2	Shengli Oilfield Central Hospital	Dongying	Shandong	China
3	The Second People's Hospital of Liaocheng	Liaocheng		China
4	Nanyang City Center Hospital	Nanyang		China
5	The First Affiliated Hospital of Zhengzhou University	Zhengzhou		China

Sponsors and Collaborators

• Capital Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ji Xunming,MD,PhD, Principal Investigator, Capital Medical University
• ClinicalTrials.gov Identifier: NCT03561311
• Other Study ID Numbers: 2017-NEAT-2
• First Posted: Jun 19, 2018
• Last Update Posted: Nov 23, 2018
• Last Verified: Nov 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aneurysm; Aneurysm, Ruptured

Study Results

No Results Posted as of Nov 23, 2018