Clinical trial NCT03561311: The Neuroprotective Effect of Remote Ischemic Conditioning in Ruptured Aneurysm Coiling Therapy
Official title: The Neuroprotective Effect of Remote Ischemic Conditioning in Ruptured Aneurysm Coiling Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Aneurysm, Ruptured
Coiling Therapy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The presence of ≥1 new brain lesions on DWI
timeFrame: within 72 hours after endovascular treatment
Secondary outcomes:
measure: Number of new ischemic lesions
timeFrame: within 72 hours after endovascular treatment
measure: Volume of new ischemic lesions
timeFrame: within 72 hours after endovascular treatment
measure: National Institutes of Health Stroke Scale
timeFrame: 7 days or discharge
measure: Composite of Cerebrovascular events
timeFrame: 30 days
measure: Nondisabling events
timeFrame: 30 days
measure: Modified Rankin Scale
timeFrame: 30 days
Other outcomes:
measure: Occurrence of adverse events and serious adverse events
timeFrame: 30 days
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Dongying
country: China
facility: Shengli Oilfield Central Hospital
state: Shandong
city: Liaocheng
country: China
facility: The Second People's Hospital of Liaocheng
city: Nanyang
country: China
facility: Nanyang City Center Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
References: