The Neuroprotective Effect of Remote Ischemic Conditioning in Aneurysm Coiling Therapy

Phase 2

• Conditions: Aneurysm
• Interventions: Device: remote ischemic conditioning; Device: sham remote ischemic conditioning

• Registration Number: NCT03496415
• Lead Sponsor: Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-12
• Study Start: 2018-05-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-21
• Last Update Posted: 2018-11-23
• Primary Completion: 2018-12-01
• Study Completion: 2019-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote ischemic conditioning	remote ischemic conditioning	-
Sham remote ischemic conditioning	sham remote ischemic conditioning	-

Primary Outcome Measures

Name	Time	Method
The presence of ≥1 new brain lesions on DWI	within 72 hours after endovascular treatment	Assessed by DWI

Secondary Outcome Measures

Name	Time	Method
Number of new ischemic lesions	within 72 hours after endovascular treatment
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.
Volume of new ischemic lesions	within 72 hours after endovascular treatment
Cerebrovascular events	30 days	Cerebrovascular events included ischemic stroke, hemorrhagic stroke, and TIA.
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
Modified Rankin Scale	30 days	Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).

Trial Locations

Locations (6)

Suzhou Municipal Hoapital; 🇨🇳 Suzhou, An Hui, China

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine; 🇨🇳 Zhengzhou, Henan, China

Shengli Oilfield Center Hospital; 🇨🇳 Dongying, Shandong, China

Nanyang City Center Hospital; 🇨🇳 Nanyang, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China