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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 : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hui-Sheng Chen, General Hospital of Shenyang Military Region

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
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
Guideline-based therapy




Primary Outcome Measures :
  1. Proportion of mRS (0-1) [ Time Frame: 90±7 days ]

Secondary Outcome Measures :
  1. Proportion of mRS (0-2) [ Time Frame: 90±7 days ]
  2. Incidence of early neurological deterioration [ Time Frame: 7 days ]
    more than 4 NIHSS score increase compared with baseline

  3. Incidence of stroke associated pneumonia [ Time Frame: 12±2 days ]
  4. occurrence of stroke or other vascular events [ Time Frame: 90±7 days ]
  5. proportion of death of any cause [ Time Frame: 90±7 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient age ≥18 years;
  2. From onset to treatment ≤ 48 hours;
  3. Ischemic stroke confirmed by head CT or MRI;
  4. 6≤NIHSS score ≤ 16;
  5. Premorbid mRS ≤ 1;
  6. Signed informed consent.

Exclusion Criteria:

  1. Serious neurological deficits before onset ( mRS ≥ 2);
  2. The aetiology of cardiogenic embolism, such as rheumatic mitral or aortic stenosis, artificial heart valve, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, left ventricular wall thrombus or valve neoplasm, congestive heart failure, bacterial endocarditis, etc;
  3. Uncontrolled severe hypertension (Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg after drug treatment);
  4. Subclavian artery stenosis ≥ 50% or subclavian steal syndrome;
  5. Intracranial tumor, arteriovenous malformation or aneurysm;
  6. Severe abnormalities in coagulation;
  7. Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc.;
  8. Comorbidity with any serious diseases and life expectancy is less than half a year;
  9. Participating in other clinical trials within 3 months;
  10. Patients not suitable for this clinical studies considered by researcher;

Information from the National Library of Medicine

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): NCT03740971


Contacts
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Contact: Xinhong Wang, Doctor 15309885658 ext 024-28897512 450341972@qq.com
Contact: Yu Cui, Master 18842398646 ext 024-28897512 314486939@qq.com

Locations
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China
General Hospital of ShenYang Military Region Recruiting
ShenYang, China
Contact: Xin-Hong wang       450341972@qq.com   
Sponsors and Collaborators
General Hospital of Shenyang Military Region
Investigators
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Study Chair: Huisheng Chen, Doctor Neurology Department

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Responsible Party: Hui-Sheng Chen, Department director, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT03740971     History of Changes
Other Study ID Numbers: k(2018)43
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases