Efficacy Study II on Remote Ischemic Conditioning for the Prevention of Stroke-Associated Pneumonia
NCT ID: NCT05982015
Last Updated: 2024-12-27
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
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COMPLETED
NA
1651 participants
INTERVENTIONAL
2024-01-22
2024-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intervention group
Remote ischemic conditioning (RIC) -200mmHg and best medical management
Remote ischemic conditioning
The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.
Sham group
Remote ischemic conditioning (RIC) -60mmHg and best medical management
Sham remote ischemic conditioning
The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 60 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.
Interventions
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Remote ischemic conditioning
The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.
Sham remote ischemic conditioning
The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 60 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of acute ischemic stroke;
* Remote ischemic conditioning or sham-remote ischemic conditioning can be treated within 24 hours after stroke onset
* NIHSS score≥4;
* Subject or his or her legally authorized representative was able to provide informed consent.
Exclusion Criteria
* Evidence of lung infection, urinary tract infection or other infectious diseases during the screening period
* Expected lifespan less than 7 days
* Mechanical ventilation is expected to be required within 7 days;
* Anti-infective drug were used within 7 days prior to stroke;
* Uncontrolled hypertension with medication (defined as systolic blood pressure ≥200 mmHg and/or diastolic blood pressure ≥110 mmHg);
* There are contraindications for remote ischemic conditioning (such as skin and soft tissue injury, fractures, peripheral arterial disease, etc. in the upper limbs);
* History of autoimmune disease or malignancies;
* Use of immunosuppressive drug within the preceding 3 months;
* Pregnant or lactating, or pregnancy test positive;
* Current participation in another investigational trial;
* Other conditions are not suitable for this trial as evaluated by researchers.
18 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Ji Xunming,MD,PhD
Professor
Principal Investigators
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Chuanjie Wu, M.D.
Role: STUDY_DIRECTOR
Xuanwu Hospital of Capital Medical University
Locations
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Xuanwu Hospital, Capital Medical University
Beijing, , China
Countries
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References
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Westendorp WF, Vermeij JD, Zock E, Hooijenga IJ, Kruyt ND, Bosboom HJ, Kwa VI, Weisfelt M, Remmers MJ, ten Houten R, Schreuder AH, Vermeer SE, van Dijk EJ, Dippel DW, Dijkgraaf MG, Spanjaard L, Vermeulen M, van der Poll T, Prins JM, Vermeij FH, Roos YB, Kleyweg RP, Kerkhoff H, Brouwer MC, Zwinderman AH, van de Beek D, Nederkoorn PJ; PASS investigators. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial. Lancet. 2015 Apr 18;385(9977):1519-26. doi: 10.1016/S0140-6736(14)62456-9. Epub 2015 Jan 20.
Kalra L, Irshad S, Hodsoll J, Simpson M, Gulliford M, Smithard D, Patel A, Rebollo-Mesa I; STROKE-INF Investigators. Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial. Lancet. 2015 Nov 7;386(10006):1835-44. doi: 10.1016/S0140-6736(15)00126-9. Epub 2015 Sep 3.
Hoffmann S, Harms H, Ulm L, Nabavi DG, Mackert BM, Schmehl I, Jungehulsing GJ, Montaner J, Bustamante A, Hermans M, Hamilton F, Gohler J, Malzahn U, Malsch C, Heuschmann PU, Meisel C, Meisel A; PREDICT Investigators. Stroke-induced immunodepression and dysphagia independently predict stroke-associated pneumonia - The PREDICT study. J Cereb Blood Flow Metab. 2017 Dec;37(12):3671-3682. doi: 10.1177/0271678X16671964. Epub 2016 Oct 14.
Chamorro A, Meisel A, Planas AM, Urra X, van de Beek D, Veltkamp R. The immunology of acute stroke. Nat Rev Neurol. 2012 Jun 5;8(7):401-10. doi: 10.1038/nrneurol.2012.98.
Iadecola C, Anrather J. The immunology of stroke: from mechanisms to translation. Nat Med. 2011 Jul 7;17(7):796-808. doi: 10.1038/nm.2399.
Chamorro A, Urra X, Planas AM. Infection after acute ischemic stroke: a manifestation of brain-induced immunodepression. Stroke. 2007 Mar;38(3):1097-103. doi: 10.1161/01.STR.0000258346.68966.9d. Epub 2007 Jan 25.
Randhawa PK, Bali A, Jaggi AS. RIPC for multiorgan salvage in clinical settings: evolution of concept, evidences and mechanisms. Eur J Pharmacol. 2015 Jan 5;746:317-32. doi: 10.1016/j.ejphar.2014.08.016. Epub 2014 Aug 28.
Jia L, Hou C, Mei Q, Zhang B, Zhao W, Zhao H, Shang S, Guo X, Ma Q, Song H, Li C, Meng R, Xu W, Wang Y, Xu G, Wu C, Ji X, Investigators FTR. Remote ischemic conditioning for the prevention of stroke-associated pneumonia (RICA-2): protocol for a multicenter, prospective, randomized, double-blind, sham-controlled phase III trial. Trials. 2025 Oct 16;26(1):419. doi: 10.1186/s13063-025-09140-x.
Other Identifiers
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RICA-2
Identifier Type: -
Identifier Source: org_study_id