Clinical trial NCT02323425: Effects of Limb Ischemic Postconditioning in Young sICAS
Official title: Effects of Upper Limb Ischemic Postconditioning on Collateral Circulation in Young Symptomatic Intracranial Atherosclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
Remote ischemic postconditioning
symptomatic atherosclerotic intracranial arterial stenosis
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
First posted: 2014-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the protective effects of upper limb ischemic postconditioning on collateral circulationin young symptomatic intracranial atherosclerosis and the baseline characteristics of trial participants, as an open, randomized controlled, prospective controlled trial.

Detailed description: Stroke is a common cardia-cerebrovascular disease with high morbidity, disability and mortality rate. And more and more young patients account for the increasing morbidity. Among them, Symptomatic intracranial atherosclerotic stenosis（sICAS）is a major cause, especially in Asians.

Currently, traditional therapeutic methods present reluctant achievements on reducing stroke recurrence and pose threat on patients'health because of invasive operation and severe side effects. Therefore, other treatment methods are called for urgently. Remote ischemic post-conditioning refers to local or distal ischemia treatment after the occurrence of cerebral ischemia. Prior research has shown that repeatedly ischemic reperfusion have protective effect on lowering the occurrence rate of ischemic events of patients with carotid stenosis. However, in-depth research on cerebral protection and correlation with collateral circulation has not been proven in an open, definitive clinical trial.

Thus, the EPIC-sICAS trial will provide important information on the protective effects of upper limb ischemic post-conditioning on collateral circulation after cerebral Infarction. Hopefully to present us a very meaningful way to improve the patient's quality of life.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 to 45 Years old;
2. Symptomatic intracranial atherosclerotic stenosis (sICAS): cranial CTA/MRA/TCD/DSA confirm the diagnosis, patients got ischemic stroke or transient ischemic attack in the brain region supplied by the stenosis artery;
3. National Institutes of Health Stroke Scale(NIHSS) score 0-15
4. Written informed consent was signed.

Exclusion Criteria:

1. Cerebral hemorrhage and other parts of the active bleeding disease;
2. Severe aphasia, unable to express himself;
3. A history of brain tumor, brain trauma, cerebral embolism or other brain lesions;
4. Severe lesions of severe cardiac, liver or kidney disease, malignancy or other systemic organ dysfunction;
5. Blood Pressure\< 90 mmHg/60 mmHg or \>200 mmHg/110 mmHg after treatment;
6. Dementia and mental illness;
7. Using angiotensin-converting enzyme inhibitors;
8. A history of major surgery or trauma 4 weeks prior to admission;
9. Without informed consent.

Elimination Criteria：

1. Patients with poor compliance，refuse to take regular treatment and examination;
2. patients' condition get exacerbated, with NIHSS score elevate for more than 4.

Primary outcomes:
measure: Mean Change of Collateral Circulation from Baseline and at 6 months
timeFrame: Baseline and at 6 months
Secondary outcomes:
measure: Mean Change of Symptomatic Recovery
timeFrame: Baseline and at 14 days, 1 month, 6 months, and 1 year
measure: Mean Change of serum vascular endothelial growth factor (VEGF) and basic Fibroblast Growth Factor (bFGF) from Baseline and at 10 days.
timeFrame: Baseline and at 10 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: GuoGang Luo, M.D/Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Capital Medical University
name: Xunming Ji, M.D/Ph.D
role: STUDY_DIRECTOR
References: