Optimized Remote Ischemic Conditioning (RIC) Treatment for Patients With Chronic Cerebral Ischemia
NCT ID: NCT03105141
Last Updated: 2017-12-05
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2/PHASE3
600 participants
INTERVENTIONAL
2017-06-01
2020-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
RIC is a novel therapeutic approach whereby repetitive, transient, non-lethal ischemia intervened by reperfusion employed on a distant organ or tissue confers protection to targeted organs against subsequent major ischemic attack. Preclinical experimental studies have demonstrated the neuroprotective effects of RIC in ischemic stroke models. Meanwhile, small-scale, proof of concept clinical trials revealed that long-term RIC was able to lower the stroke recurrence and enhance the cerebral reperfusion, without inducing adverse events in patients with ICAS. Nevertheless, current protocol of RIC utilited in this scenario was mainly based on previous animal studies or cardiovascular clinical trials. Whether modifying the ischemic pressure, numbers of cycles, duration of ischemia as well as the method for application can lead to different outcomes remain to be settled. In this study, 600 patients satisfied with the inclusion criteria will be recruited and randomly allocated into four substudies to receive RIC treatment (Doctormate®) under different algorithms. The most optimal algorithm of RIC on patients with ICAS related CCI would be determined according to clinical endpoints. Other medical managements are guaranteed based on the best medical judgment from clinical practitioners.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RIC substudy 1
A total of 120 patients in this substudy will receive standard medical therapy and bilateral upper limb remote ischemic conditioning intervention (Doctormate®) (200 mmHg or 40 mmHg above systolic pressure) twice daily for 12 months.
Remote ischemic conditioning
Remote ischemic conditioning is composed of 5 cycles of 5-min bilateral upper limb ischemia intervened by 5-min reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to a given pressure followed by deflation, twice daily for 12 months.
Two different magnitude of limb ischemia pressure will be set: 200 mmHg and 40 mmHg above systolic pressure (60 patients for each).
Optimal inflating pressure will be determined based on the results.
RIC substudy 2
A total of 180 patients in this substudy will receive standard medical therapy and bilateral upper limb remote ischemic conditioning intervention (Doctormate®) (200 mmHg) twice daily for 12 months.
Remote ischemic conditioning
Remote ischemic conditioning is composed of a given cycle of 5-min bilateral upper limb ischemia intervened by 5-min reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to 200 mmHg pressure followed by deflation, twice daily for 12 months.
The number of cycles of limb ischemia will be set as: 4, 5 and 6 (60 patients for each).
Optimal cycles for application will be determined based on the results.
RIC substudy 3
A total of 180 patients in this substudy will receive standard medical therapy and bilateral upper limb remote ischemic conditioning intervention (Doctormate®) (200 mmHg) twice daily for 12 months.
Remote ischemic conditioning
Remote ischemic conditioning is composed of 5 cycles of a given duration of bilateral upper limb ischemia intervened by reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to 200 mmHg pressure followed by deflation, twice daily for 12 months.
The duration of each cycle for limb ischemia will be set as: 4, 5 and 6-min (60 patients for each).
Ischemia duration algorithm will be determined based on the results.
RIC substudy 4
A total of 120 patients in this substudy will receive standard medical therapy and bilateral upper limb remote ischemic conditioning intervention (Doctormate®) (200 mmHg) once or twice daily for 12 months.
Remote ischemic conditioning
Remote ischemic conditioning is composed of 5 cycles of 5-min bilateral upper limb ischemia intervened by reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to 200 mmHg pressure followed by deflation, once or twice daily for 12 months.
The method for application will be set as: once daily for 12 months and twice daily for 12 months (60 patients for each).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Remote ischemic conditioning
Remote ischemic conditioning is composed of 5 cycles of 5-min bilateral upper limb ischemia intervened by 5-min reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to a given pressure followed by deflation, twice daily for 12 months.
Two different magnitude of limb ischemia pressure will be set: 200 mmHg and 40 mmHg above systolic pressure (60 patients for each).
Optimal inflating pressure will be determined based on the results.
Remote ischemic conditioning
Remote ischemic conditioning is composed of a given cycle of 5-min bilateral upper limb ischemia intervened by 5-min reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to 200 mmHg pressure followed by deflation, twice daily for 12 months.
The number of cycles of limb ischemia will be set as: 4, 5 and 6 (60 patients for each).
Optimal cycles for application will be determined based on the results.
Remote ischemic conditioning
Remote ischemic conditioning is composed of 5 cycles of a given duration of bilateral upper limb ischemia intervened by reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to 200 mmHg pressure followed by deflation, twice daily for 12 months.
The duration of each cycle for limb ischemia will be set as: 4, 5 and 6-min (60 patients for each).
Ischemia duration algorithm will be determined based on the results.
Remote ischemic conditioning
Remote ischemic conditioning is composed of 5 cycles of 5-min bilateral upper limb ischemia intervened by reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to 200 mmHg pressure followed by deflation, once or twice daily for 12 months.
The method for application will be set as: once daily for 12 months and twice daily for 12 months (60 patients for each).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2\. Patients diagnosed with an ischemic stroke or TIA before admission and the following requirements should be satisfied as well:
1. The occurrence of an ischemic stroke within 30 days and with a baseline modified Rankin Scale (mRS) score≤4.
2. The occurrence of an TIA within 15 days and with a baseline Oxfordshire Community Stroke Project on the basis of age, blood pressure (BP), clinical features, and duration of TIA symptoms (ABCD2) score≥4.
3\. Patients with symptomatic intracranial atherosclerotic stenosis (sIAS) that is attributed to at least 50% stenosis of the diameter of a major intracranial artery (carotid artery, or middle cerebral artery (M1)) verified by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA).
4\. Informed consent obtained patients or health care proxy, as appropriate, able to cooperate and participate follow-up visits.
Exclusion Criteria
2\. Progressive deterioration of neurological manifestations within 24 hours prior to inclusion.
3\. Intracranial arterial stenosis due to any of the following non-atherosclerotic etiologies, for instance, moyamoya disease, artery dissection, any known vasculitic disease, any intracranial infection, radiation induced vasculopathy, cerebrospinal fluid (CSF) pleocytosis associated intraarterial stenosis, genetic or developmental abnormalities such as fibromuscular dysplasia, neurofibromatosis, sickle cell disease, and mitochondrial encephalopathy, intracranial granulomatous arteritis, postpartum angiopathy, suspected vasospasm or embolism, iatrogenic trauma.
4\. Intracranial abnormalities such as tumor, abscess, vascular malformation, cerebral venous sinus stenosis or thrombosis.
5\. Any hemorrhagic transformation or large area of cerebral infarction (more than 1/3 of middle cerebral artery perfusion territory).
6\. Any type of intracranial hemorrhage within 90 days prior to inclusion.
7\. Potential cardiac source of embolism such as rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial flutter, atrial fibrillation, left atrial myxoma, sick sinus syndrome, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, and bacterial endocarditis.
8\. Previous stent, angioplasty, or other mechanical device in the target lesion, or plan to receive any of the above procedures within 12 months after inclusion.
9\. Refractory hypertension (systolic blood pressure (SBP) \>180 mmHg; diastolic blood pressure (DBP) \>110 mmHg) that cannot be controlled by medical intervention.
10\. Above 50% stenosis of extracranial artery (carotid artery or vertebral artery).
11\. Above 50% stenosis of subclavian artery or subclavian steal syndrome.
12\. Retinal hemorrhage or visceral bleeding within 30 days prior to inclusion.
13\. Myocardial infarction within previous 30 days prior to inclusion.
14\. Previous history of major surgery within 30 days prior to inclusion, or arranged for any of the procedure within 12 months after inclusion.
15\. Severe hemostatic or coagulation disorders (Haemoglobin \<10 g/dL, blood platelet count \< 100 × 109/L).
16\. Hepatic or renal dysfunctions (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)).
17\. Current or having a history of chronic physical diseases or mental disorders.
18\. Life expectancy \< 3 years due to concomitant life-threatening illness.
19\. Contraindications for remote ischemic conditioning: significant peripheral arterial disease, soft tissue or vascular injury, wounds, and fracture affecting the upper limbs.
20\. Pregnant or lactating women.
21\. Patients unlikely to be compliant with intervention or return for follow-up visits.
22\. No consent obtained from the patient or available legally authorized representatives.
23\. Patients recruited into another clinical investigation with medication or device, which is likely to impact the outcome of this study.
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Capital Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ji Xunming
Vice President, Professor, Xuanwu Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xuming Ji, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Xuanwu Hospital, Beijing
Ran Meng, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Xuanwu Hospital, Beijing
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Xuanwu Hospital, Capital Medical University
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Xunming Ji
Role: primary
Ran Meng, MD, PhD
Role: primary
Da Zhou, MD, PhD Candidate
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3.
Meng R, Ding Y, Asmaro K, Brogan D, Meng L, Sui M, Shi J, Duan Y, Sun Z, Yu Y, Jia J, Ji X. Ischemic Conditioning Is Safe and Effective for Octo- and Nonagenarians in Stroke Prevention and Treatment. Neurotherapeutics. 2015 Jul;12(3):667-77. doi: 10.1007/s13311-015-0358-6.
Wang Y, Zhao X, Liu L, Soo YO, Pu Y, Pan Y, Wang Y, Zou X, Leung TW, Cai Y, Bai Q, Wu Y, Wang C, Pan X, Luo B, Wong KS; CICAS Study Group. Prevalence and outcomes of symptomatic intracranial large artery stenoses and occlusions in China: the Chinese Intracranial Atherosclerosis (CICAS) Study. Stroke. 2014 Mar;45(3):663-9. doi: 10.1161/STROKEAHA.113.003508. Epub 2014 Jan 30.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RIC2017-CCI
Identifier Type: -
Identifier Source: org_study_id