Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke (RICAMIS)
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|ClinicalTrials.gov Identifier: NCT03740971|
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : May 29, 2020
The current treatment based on evidence-based medicine for acute ischemic stroke mainly includes reperfusion (intravenous thrombolysis, mechanical thrombolysis), anti-platelet and stroke units. About 1/3 patients can obtain good prognosis through intravenous thrombolysis. Good prognosis can be gotten from about 50 percent of patients with big artery disease by mechanical embolization. However, only a small proportion of the population can be treated with restoration perfusion in the time window. The main purpose of antiplatelet therapy is to prevent the recurrence and progression of stroke, and stroke unit is a kind of management mode. How to improve the neurological function of patients has been a hot and difficult problem in clinical practice.
A large number of basic and clinical studies have proved that remote ischemic conditioning (RIC) has protective effect on ischemic stroke. Hahn et al showed that RIC could play a neuroprotective role in cerebral ischemia-reperfusion injury in MCAO model. Other studies have also confirmed that preconditioning RIC has a neuroprotective effect on cerebral ischemia in animal models. One open label study by Hougaard et al shows that RIC can improve the NIHSS score in acute ischemic stroke patients. One recent study found that 300 consecutive days RIC therapy for the patients with symptomatic intracranial atherosclerotic stenosis significantly reduced the recurrence rate of stroke, improved the mRS score and recovered the blood flow in the lesion site. Furthermore, several studies have also shown that RIC can not only improve the neurological function of patients with cerebral infarction after intravenous thrombolysis and mechanical thrombolysis, but also protect the secondary brain injury after carotid stenting. These results suggest that RIC has a neuroprotective effect on ischemic stroke and deserves further study.
Based on the above discussion, this study aims to explore the efficacy and safety of RIC in the treatment of acute moderate ischemic stroke.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Remote Ischemic Conditioning treatment Drug: Guideline-based therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke (RICAMIS): a Prospective, Random, Open Label, Blinded End Point, Multi-center Study|
|Actual Study Start Date :||December 26, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Guideline-based therapy+RIC
RIC is given twice a day with 200mmHg pressure.
Device: Remote Ischemic Conditioning treatment
Remote Ischemic Conditioning is given twice a day with 200mmHg pressure.
|Active Comparator: Guideline-based therapy||
Drug: Guideline-based therapy
- Proportion of mRS (0-1） [ Time Frame: 90±7 days ]
- Proportion of mRS (0-2） [ Time Frame: 90±7 days ]
- Incidence of early neurological deterioration [ Time Frame: 7 days ]more than 4 NIHSS score increase compared with baseline
- Incidence of stroke associated pneumonia [ Time Frame: 12±2 days ]
- occurrence of stroke or other vascular events [ Time Frame: 90±7 days ]
- proportion of death of any cause [ Time Frame: 90±7 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740971
|Contact: Xinhong Wang, Doctor||15309885658 ext firstname.lastname@example.org|
|Contact: Yu Cui, Master||18842398646 ext email@example.com|
|General Hospital of ShenYang Military Region||Recruiting|
|Contact: Xin-Hong wang firstname.lastname@example.org|
|Study Chair:||Huisheng Chen, Doctor||Neurology Department|