Remote Ischemic Conditioning for Avoiding Recurrence of Symptomatic Intracranial Atherosclerotic Stenosis (sICAS)
NCT ID: NCT02534545
Last Updated: 2018-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
3000 participants
INTERVENTIONAL
2015-10-31
2019-09-30
Brief Summary
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After screening period, eligible patients will be randomly allocated into 2 groups. In addition, all participants receive an usual clinical therapy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Doctormate® (200mmHg)
Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 12 months
Doctormate® (200mmHg)
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
Doctormate® (60mmHg)
Patients will be treated with the Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 12 months
Doctormate® (60mmHg)
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.
Interventions
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Doctormate® (200mmHg)
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
Doctormate® (60mmHg)
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.
Eligibility Criteria
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Inclusion Criteria
2. Patients having an ischemic stroke or a TIA prior to randomization.
* Patient having an ischemic stroke within 30 days with mRS score≤4 at baseline.
* Patient having a TIA within 15 days with Oxfordshire Community Stroke Project on the basis of age, blood pressure (BP), clinical features, and duration of TIA symptoms (ABCD2) score≥4 at baseline.
3. The entry event is attributed to symptomatic atherosclerotic stenosis (50-99%) in an intracranial qualifying artery (carotid artery, middle cerebral artery (M1), vertebral artery, or basilar artery) that is documented by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA).
4. Informed consent obtained.
Exclusion Criteria
2. Progressive neurological signs within 24 hours prior to enrollment.
3. Cerebral venous thrombosis/stenosis.
4. Intracranial arterial stenosis due to arterial dissection, Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid (CSF) pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus.
5. Any of the following unequivocal cardiac source of embolism: rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with the participation.
6. Uncontrolled severe hypertension \[sitting systolic blood pressure (SBP) \>180 mmHg and/or sitting diastolic blood pressure (DBP) \>110 mmHg after medication\].
7. Patients with abnormal laboratory parameters: aspartate transaminase (AST) and/or alanine transaminase (ALT) \>3×upper limit of normal range; creatinine clearance \<0.6 ml/s and/or serum creatinine \>265 μmol/l (\>3.0 mg/dl); platelets \<100×109/L.
8. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) within 90 days prior to enrollment.
9. Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation.
10. Known retinal hemorrhage or visceral bleeding within 30 days prior to enrollment.
11. Severe hemostatic disorder or severe coagulation dysfunction.
12. Subclavian arterial stenosis≥50% or subclavian steal syndrome.
13. Extracranial stenosis ≥50%.
14. Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform one of these procedures within 12 months after enrollment.
15. Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within previous 30 days or scheduled in the 12 months after enrollment.
16. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
17. Life expectancy\<3 years.
18. Pregnant or breast-feeding women.
19. Unwilling to be followed up or poor compliance for treatment.
20. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
21. Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
40 Years
80 Years
ALL
No
Sponsors
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Ji Xunming,MD,PhD
OTHER
Responsible Party
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Ji Xunming,MD,PhD
VP, Professor
Principal Investigators
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Xunming Ji, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Xuanwu Hospital, Beijing
Locations
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Wuhu NO.2 People's Hospital
Wuhu, Anhui, China
The Hospital of Shunyi District Beijing
Beijing, Beijing Municipality, China
Beijing Huairou Hospital
Beijing, Beijing Municipality, China
Baoding No.1 Hospital
Baoding, Hebei, China
Cangzhou People Hospital
Cangzhou, Hebei, China
Hebei Province Cangzhou Hospital of Integrated Traditional and Western Medicine
Cangzhou, Hebei, China
Chengde Central Hospital
Chengde, Hebei, China
Handan First Hospital
Handan, Hebei, China
Hebei General Hospital
Shijiazhuang, Hebei, China
Shijiazhuang The First Hospital
Shijiazhuang, Hebei, China
Shijiazhuang The Third Hospital
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Third Houspital of Xingtai
Xingtai, Hebei, China
Xingtai People's Hospital
Xingtai, Hebei, China
The First Clinical Hospital affiliated to Harbin Medical University
Harbin, Heilongjiang, China
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Luohe Central Hospital
Luohe, Henan, China
Shangqiu First People's Hospital
Shangqiu, Henan, China
Xuchang Central Hospital
Xuchang, Henan, China
Zhumadian Ctentral Hospital
Zhumadian, Henan, China
Technology The Central Hospital of Wuhan
Wuhan, Hubei, China
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China
Changzhou NO.2 People's Hospital
Changzhou, Jiangsu, China
Anshanshi Changda The Hospital
Anshan, Liaoning, China
Chaoyang Central Hospital
Chaoyang, Liaoning, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, China
Jinzhou Central Hopital
Jinzhou, Liaoning, China
The Third Affiliated Hospital of Liaoning Medical College
Jinzhou, Liaoning, China
The First People's Hospital of Shenyang
Shenyang, Liaoning, China
The General Hospital of Shenyang Military
Shenyang, Liaoning, China
The Peoele's Hospital of Liaoning Province
Shenyang, Liaoning, China
Ankang City Central Hospital
Ankang, Shaanxi, China
Dezhou People's Hospital
Dezhou, Shandong, China
Shengli Oilfield Central Hospital
Dongying, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Rizhao Hospital of Traditional Chinese Medicine
Rizhao, Shandong, China
Affiliated Hospital of Weifang Medical University
Weifang, Shandong, China
Peace Hospital Affiliated to Changzhi Medical College Shanxi Province
Changzhi, Shanxi, China
Fenyang Hospital of Shanxi Medical Unversity
Fenyang, Shanxi, China
First Hospital of Shanxi Medical Unversity
Taiyuan, Shanxi, China
Shanxi College of Traditional Chinese Medicine Hospital
Taiyuan, Shanxi, China
Tianjin 4th Centre Hospital
Tianjin, Tianjin Municipality, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Shaoxing Central Hospital
Shaoxing, Zhejiang, China
Zhoushan Putuo Hospital
Zhoushan, Zhejiang, China
Xuanwu Hospital, Capital Medical University
Beijing, , China
Beijing Aerospace General Hospital
Beijing, , China
Beijing Luhe Hospital, Capital Medical University
Beijing, , China
Xiyuan Hospital, China Academy of Chinses Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Hongbo Pang
Role: primary
Quping Ouyang
Role: primary
Fuying Yu
Role: primary
Chunsheng Wang
Role: primary
Jie Huang
Role: primary
Zhiyong Wang
Role: primary
Haisong Du
Role: primary
Liping Cheng
Role: primary
Peiyuan Lu
Role: primary
Zhenquan Yan
Role: primary
Yunshu Zhang
Role: primary
Xueqin Song
Role: primary
Yuqing Wei
Role: primary
Peilin Hu
Role: primary
Guozhong Li
Role: primary
Zhuobo Zhang
Role: primary
Chunling Zheng
Role: primary
Yan Fang
Role: primary
Tao Li
Role: primary
Xuezhang Lai
Role: primary
Linhong Zhang
Role: primary
Runxiu Zhu
Role: primary
Zhuoyou Chen
Role: primary
Xiujie Han
Role: primary
Xiaomei He
Role: primary
Hong Wang
Role: primary
Dongyu Wang
Role: primary
Hui Zhang
Role: primary
Jin Zhou
Role: primary
Huisheng Chen
Role: primary
Xiaohong Chen
Role: primary
Kaifu Jiang
Role: primary
Shaohua Su
Role: primary
Zongen Gao
Role: primary
Hongxing Han
Role: primary
Wei Ding
Role: primary
Xianwei Zeng
Role: primary
Yufen Wang
Role: primary
Xueying Guo
Role: primary
Xiaoyuan Niu
Role: primary
Aimei Wang
Role: primary
Hongxin Wang
Role: primary
Wei Yue
Role: primary
Junwei Hao
Role: primary
Ke Shen
Role: primary
Ming Wang
Role: primary
Xunming Ji
Role: primary
Jilai Li
Role: primary
Huishan Du
Role: primary
Chenguang Tong
Role: primary
References
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Hou C, Lan J, Lin Y, Song H, Wang Y, Zhao W, Li S, Meng R, Hao J, Ding Y, Chimowitz MI, Fisher M, Hess DC, Liebeskind DS, Hausenloy DJ, Huang J, Li Z, Han X, Yang J, Zhou J, Chen P, Zhu X, Hu P, Pang H, Chen W, Chen H, Li G, Tao D, Yue W, Gao Z, Ji X; RICA investigators. Chronic remote ischaemic conditioning in patients with symptomatic intracranial atherosclerotic stenosis (the RICA trial): a multicentre, randomised, double-blind sham-controlled trial in China. Lancet Neurol. 2022 Dec;21(12):1089-1098. doi: 10.1016/S1474-4422(22)00335-0. Epub 2022 Oct 27.
Other Identifiers
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RICA
Identifier Type: -
Identifier Source: org_study_id
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