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

Aneurysm, Ruptured Clinical Trial

— NEAT-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03561311
• Other study ID #: 2017-NEAT-2
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 6, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: November 2018
• Source: Capital Medical University
• Contact: Xunming Ji, MD
• Phone: 008601083198930
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 30, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Ruptured
• Coiling Therapy
• Rupture

Intervention

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 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

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	Shengli Oilfield Central Hospital	Dongying	Shandong
China	The Second People's Hospital of Liaocheng	Liaocheng
China	Nanyang City Center Hospital	Nanyang
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurrence of adverse events and serious adverse events	Occurrence of adverse events and serious adverse events	30 days
Primary	The presence of =1 new brain lesions on DWI	Assessed by DWI	within 72 hours after endovascular treatment
Secondary	Number of new ischemic lesions		within 72 hours after endovascular treatment
Secondary	Volume of new ischemic lesions		within 72 hours after endovascular treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	Modified Rankin Scale	Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).	30 days