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

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.

Study Overview

• Status: Unknown
• Conditions: Aneurysm, Ruptured; Coiling Therapy
• Intervention / Treatment: Device: remote ischemic conditioning; Device: sham remote ischemic conditioning

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Liaocheng, China
    • Recruiting
    • The Second People's Hospital of Liaocheng
    • Contact: Wansheng Chang
  • Nanyang, China
    • Recruiting
    • Nanyang City Center Hospital
  • Zhengzhou, China
    • Recruiting
    • The First Affiliated Hospital of Zhengzhou University
  • Beijing
    • Beijing, Beijing, China, 100053
      • Not yet recruiting
      • Xuanwu Hospital, Capital Medical University
  • Shandong
    • Dongying, Shandong, China
      • Recruiting
      • Shengli Oilfield Central Hospital
      • Contact: Zongen Gao
      • Principal Investigator: Zongen Gao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The presence of ≥1 new brain lesions on DWI	Assessed by DWI	within 72 hours after endovascular treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of new ischemic lesions		within 72 hours after endovascular treatment
Volume of new ischemic lesions		within 72 hours after endovascular treatment
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.	7 days or discharge
Modified Rankin Scale	Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).	30 days
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.	30 days
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.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse events and serious adverse events	Occurrence of adverse events and serious adverse events	30 days

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2018
• Primary Completion (Anticipated): May 31, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 16, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Ruptured
• Other Study ID Numbers: 2017-NEAT-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No