The Neuroprotective Effect of Remote Ischemic Conditioning in Aneurysm Coiling Therapy

NCT ID: NCT03496415

Last Updated: 2018-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-03

Study Completion Date

2019-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aneurysm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Remote ischemic conditioning

Group Type EXPERIMENTAL

remote ischemic conditioning

Intervention Type DEVICE

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

Group Type SHAM_COMPARATOR

sham remote ischemic conditioning

Intervention Type DEVICE

sham remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 60 mm Hg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ji Xunming,MD,PhD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Suzhou Municipal Hoapital

Suzhou, Anhui, China

Site Status RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

Shengli Oilfield Center Hospital

Dongying, Shandong, China

Site Status RECRUITING

Nanyang City Center Hospital

Nanyang, , China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xunming Ji, MD

Role: CONTACT

008601083198930

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhengfei Ma, MD

Role: primary

Xunming Ji

Role: primary

Dongsheng Guan

Role: primary

Zongen Gao, MD

Role: primary

8613854669979

Tianping Tang, MD

Role: backup

8618678662921

Changming Wen

Role: primary

Yajun Lian

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-NEAT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.