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Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke (RICAMIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03740971
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Hui-Sheng Chen, General Hospital of Shenyang Military Region

Tracking Information
First Submitted Date  ICMJE November 12, 2018
First Posted Date  ICMJE November 14, 2018
Last Update Posted Date May 5, 2021
Actual Study Start Date  ICMJE December 26, 2018
Actual Primary Completion Date April 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
Proportion of mRS (0-1) [ Time Frame: 90±7 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
  • 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 ]
  • change in NIHSS score compared with baseline [ Time Frame: 24 hours ]
  • occurrence of stroke or other vascular events [ Time Frame: 90±7 days ]
  • proportion of death of any cause [ Time Frame: 90±7 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke
Official Title  ICMJE Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke (RICAMIS): a Prospective, Random, Open Label, Blinded End Point, Multi-center Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Device: Remote Ischemic Conditioning treatment
    Remote Ischemic Conditioning is given twice a day with 200mmHg pressure.
  • Drug: Guideline-based therapy
    Guideline-based therapy
Study Arms  ICMJE
  • Experimental: Guideline-based therapy+RIC
    RIC is given twice a day with 200mmHg pressure.
    Intervention: Device: Remote Ischemic Conditioning treatment
  • Active Comparator: Guideline-based therapy
    Intervention: Drug: Guideline-based therapy
Publications * Chen HS, Cui Y, Li XQ, Wang XH, Ma YT, Zhao Y, Han J, Deng CQ, Hong M, Bao Y, Zhao LH, Yan TG, Zou RL, Wang H, Li Z, Wan LS, Zhang L, Wang LQ, Guo LY, Li MN, Wang DQ, Zhang Q, Chang DW, Zhang HL, Sun J, Meng C, Zhang ZH, Shen LY, Ma L, Wang GC, Li RH, Zhang L, Bi C, Wang LY, Wang DL; RICAMIS Investigators. Effect of Remote Ischemic Conditioning vs Usual Care on Neurologic Function in Patients With Acute Moderate Ischemic Stroke: The RICAMIS Randomized Clinical Trial. JAMA. 2022 Aug 16;328(7):627-636. doi: 10.1001/jama.2022.13123.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2018)
1800
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 19, 2021
Actual Primary Completion Date April 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03740971
Other Study ID Numbers  ICMJE k(2018)43
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hui-Sheng Chen, General Hospital of Shenyang Military Region
Original Responsible Party Same as current
Current Study Sponsor  ICMJE General Hospital of Shenyang Military Region
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Huisheng Chen, Doctor Neurology Department
PRS Account General Hospital of Shenyang Military Region
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP