Remote Ischemic Conditioning for Avoiding Recurrence of Symptomatic Intracranial Atherosclerotic Stenosis (sICAS)
1 other identifier
interventional
3,000
1 country
50
Brief Summary
The primary objective of the study will be to determine whether remote limb ischemic conditioning (RLIC) compared with sham RLIC (placebo) treatment reduces the 12-month risk of recurrent IS in patients with a recent TIA or IS caused by stenosis of a major intracranial artery. After screening period, eligible patients will be randomly allocated into 2 groups. In addition, all participants receive an usual clinical therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2015
CompletedFirst Posted
Study publicly available on registry
August 27, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMay 24, 2018
May 1, 2018
3.9 years
August 23, 2015
May 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The time from randomization to the first occurrence of fatal or non-fatal ischemic stroke.
During the first 12 months from randomization.
Secondary Outcomes (3)
The time from randomization to the first occurrence of a composite of fatal or non-fatal stroke (ischemic and hemorrhagic), fatal or non-fatal myocardial infarction, and transient ischemic attack (TIA) .
During the first 12 months from randomization.
The time from randomization to the first occurrence of each component of the composite of fatal or non-fatal stroke (ischemic and hemorrhagic), fatal or non-fatal myocardial infarction, and TIA.
During the first 12 months from randomization.
Time to death from all causes from randomization.
During the first 12 months from randomization.
Other Outcomes (5)
Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
During the first 12 months from randomization.
Scores assessed by modified Rankin Scale(mRS)
During the first 12 months from randomization.
Scores assessed by Barthel Index(BI).
During the first 12 months from randomization.
- +2 more other outcomes
Study Arms (2)
Doctormate® (200mmHg)
EXPERIMENTALPatients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 12 months
Doctormate® (60mmHg)
SHAM COMPARATORPatients will be treated with the Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 12 months
Interventions
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.
Eligibility Criteria
You may qualify if:
- Male or female with age from 40 to 80 years old.
- 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.
- 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).
- Informed consent obtained.
You may not qualify if:
- Thrombolytic therapy within 24 hours prior to enrollment.
- Progressive neurological signs within 24 hours prior to enrollment.
- Cerebral venous thrombosis/stenosis.
- 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.
- 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.
- Uncontrolled severe hypertension \[sitting systolic blood pressure (SBP) \>180 mmHg and/or sitting diastolic blood pressure (DBP) \>110 mmHg after medication\].
- 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.
- Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) within 90 days prior to enrollment.
- Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation.
- Known retinal hemorrhage or visceral bleeding within 30 days prior to enrollment.
- Severe hemostatic disorder or severe coagulation dysfunction.
- Subclavian arterial stenosis≥50% or subclavian steal syndrome.
- Extracranial stenosis ≥50%.
- 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.
- Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within previous 30 days or scheduled in the 12 months after enrollment.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Wuhu NO.2 People's Hospital
Wuhu, Anhui, China
The Hospital of Shunyi District Beijing
Beijing, Beijing Municipality, 101300, 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, 100053, 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
Related Publications (1)
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.
PMID: 36354026DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xunming Ji, MD. PhD
Xuanwu Hospital, Beijing
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- VP, Professor
Study Record Dates
First Submitted
August 23, 2015
First Posted
August 27, 2015
Study Start
October 1, 2015
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
May 24, 2018
Record last verified: 2018-05