Effects of Limb Ischemic Postconditioning in Young sICAS (EPIC-sICAS)
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|ClinicalTrials.gov Identifier: NCT02323425|
Recruitment Status : Unknown
Verified January 2017 by Meng Wei, Health Science Center of Xi'an Jiaotong University.
Recruitment status was: Recruiting
First Posted : December 23, 2014
Last Update Posted : February 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Remote ischemic postconditioning||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Upper Limb Ischemic Postconditioning on Collateral Circulation in Young Symptomatic Intracranial Atherosclerosis|
|Actual Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Experimental: Remote Ischemic Postconditioning
remote ischemic postconditioning（RIPC） treatment was performed by the inflating a cuff around bilateral arms to 180 mmHg with 5 cycles of 3 min inflation and 5 min relax alternation twice a day for the total of 180 consecutive days.
Device: Remote ischemic postconditioning
Remote ischemic postconditioning（RIPC）treatment was performed by the inflating a cuff around bilateral arms to 180 mmHg with 5 cycles of 3 min inflation and 5 min relax alternation automatically.
Other Name: limb ischemic postconditioning
No Intervention: Control
Patients in control group will receive foundation treatment. Foundation treatment: including blood vessel expansion、free radical elimination etc during acute phase and aspirin (100-300 mg/d), and atorvastatin (20 mg/d) till the end of the study (180 consecutive days).
- Mean Change of Collateral Circulation from Baseline and at 6 months [ Time Frame: Baseline and at 6 months ]Collateral circulation measured in iconography test: Magnetic Resonance Angiography (MRA)、 Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)、Arterial spin-labeled (ASL) perfusion magnetic resonance、Transcranial Cerebral Doppler (TCD)、single photon emission computed tomography（SPECT） Baseline was defined as the onset of stroke within 48h. A higher score represents better collateral circulation status functioning.
- Mean Change of Symptomatic Recovery [ Time Frame: Baseline and at 14 days, 1 month, 6 months, and 1 year ]Functional test: National Institute of Health stroke scale（NIHSS）scores、Activity of Daily Living Scale (ADL) For NIHSS scores, a lower score represents better functioning. For ADL scores, a higher score represents better functioning.
- Mean Change of serum vascular endothelial growth factor (VEGF) and basic Fibroblast Growth Factor (bFGF) from Baseline and at 10 days. [ Time Frame: Baseline and at 10 days ]A higher amount represents a better outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323425
|Contact: Meng Wei, Masteremail@example.com|
|Contact: GuoGang Luo, M.D/Ph.Dfirstname.lastname@example.org|
|The First Affiliated Hospital of Xi'an Jiaotong University||Recruiting|
|Xi'an, Shaanxi, China, 710061|
|Contact: Meng Wei, graduate +8613572516964 email@example.com|
|Contact: GuoGang Luo, M.D/Ph.D +8618991232449 firstname.lastname@example.org|
|Principal Investigator: GuoGang Luo, M.D/Ph.D|
|Principal Investigator: XunMing Ji, M.D/Ph.D|
|Principal Investigator:||GuoGang Luo, M.D/Ph.D||First Affiliated Hospital Xi'an Jiaotong University|
|Study Director:||Xunming Ji, M.D/Ph.D||Capital Medical University|