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

Primary Purpose

Aneurysm, Ruptured, Coiling Therapy

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
remote ischemic conditioning
sham remote ischemic conditioning
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aneurysm, Ruptured

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xuanwu Hospital, Capital Medical University
  • Shengli Oilfield Central HospitalRecruiting
  • The Second People's Hospital of LiaochengRecruiting
  • Nanyang City Center HospitalRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Remote ischemic conditioning group

Sham remote ischemic conditioning group

Arm Description

Outcomes

Primary Outcome Measures

The presence of ≥1 new brain lesions on DWI
Assessed by DWI

Secondary Outcome Measures

Number of new ischemic lesions
Volume of new ischemic lesions
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.
Composite of Cerebrovascular events
This is a composited endpoint.Cerebrovascular events included ischemic stroke, hemorrhagic stroke, and TIA. The present subarachnoid hemorrhage isn't included.
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 The present subarachnoid hemorrhage isn't included.
Modified Rankin Scale
Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).

Full Information

First Posted
May 23, 2018
Last Updated
November 21, 2018
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03561311
Brief Title
The Neuroprotective Effect of Remote Ischemic Conditioning in Ruptured Aneurysm Coiling Therapy
Acronym
NEAT-2
Official Title
The Neuroprotective Effect of Remote Ischemic Conditioning in Ruptured Aneurysm Coiling Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 6, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm, Ruptured, Coiling Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote ischemic conditioning group
Arm Type
Experimental
Arm Title
Sham remote ischemic conditioning group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
remote ischemic conditioning
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
sham remote ischemic conditioning
Intervention Description
Sham remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 60 mm Hg
Primary Outcome Measure Information:
Title
The presence of ≥1 new brain lesions on DWI
Description
Assessed by DWI
Time Frame
within 72 hours after endovascular treatment
Secondary Outcome Measure Information:
Title
Number of new ischemic lesions
Time Frame
within 72 hours after endovascular treatment
Title
Volume of new ischemic lesions
Time Frame
within 72 hours after endovascular treatment
Title
National Institutes of Health Stroke Scale
Description
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Time Frame
7 days or discharge
Title
Composite of Cerebrovascular events
Description
This is a composited endpoint.Cerebrovascular events included ischemic stroke, hemorrhagic stroke, and TIA. The present subarachnoid hemorrhage isn't included.
Time Frame
30 days
Title
Nondisabling events
Description
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.
Time Frame
30 days
Title
Modified Rankin Scale
Description
Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Occurrence of adverse events and serious adverse events
Description
Occurrence of adverse events and serious adverse events
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xunming Ji, MD
Phone
008601083198930
Email
jixm@ccmu.edu.cn
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xunming Ji
First Name & Middle Initial & Last Name & Degree
Xunming Ji
Facility Name
Shengli Oilfield Central Hospital
City
Dongying
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zongen Gao
First Name & Middle Initial & Last Name & Degree
Zongen Gao
Facility Name
The Second People's Hospital of Liaocheng
City
Liaocheng
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wansheng Chang
Facility Name
Nanyang City Center Hospital
City
Nanyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changming Wen
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yajun Lian

12. IPD Sharing Statement

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The Neuroprotective Effect of Remote Ischemic Conditioning in Ruptured Aneurysm Coiling Therapy

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