search
Back to results

Remote Ischemic Conditioning for Stroke-associated Pneumonia (RICA-2)

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sham remote ischemic conditioning
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age≥18 years old; 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: During the screening period, body temperature ≥ 38 ℃; 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Intervention group

    Sham group

    Arm Description

    Remote ischemic conditioning (RIC) -200mmHg and best medical management

    Remote ischemic conditioning (RIC) -60mmHg and best medical management

    Outcomes

    Primary Outcome Measures

    Stroke-associated pneumonia
    Stroke-associated pneumonia incidence rate

    Secondary Outcome Measures

    Physician diagnosed pneumonia
    Physician diagnosed pneumonia incidence rate
    Physician diagnosed pneumonia
    Physician diagnosed pneumonia incidence rate
    Modified Rankin scale 0-1
    defined by 0-1 of the modified Rankin Scale (mRS)
    Modified Rankin scale 0-2
    defined by 0-2 of the modified Rankin Scale (mRS)
    Modified Rankin scale
    Shift analysis
    EQ-5D-5L
    The score of EQ-5D-5L
    NIHSS stroke scale
    The score of NIHSS stroke scale
    NIHSS stroke scale
    The score of NIHSS stroke scale
    Urinary tract infections
    Urinary tract infections incidence rate
    Infections
    Infections incidence rate
    All-cause mortality
    All-cause mortality incidence rate
    Inpatient days
    Total inpatient days

    Full Information

    First Posted
    August 1, 2023
    Last Updated
    August 1, 2023
    Sponsor
    Capital Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05982015
    Brief Title
    Remote Ischemic Conditioning for Stroke-associated Pneumonia
    Acronym
    RICA-2
    Official Title
    The Preventive Effect of Remote Ischemic Conditioning in Reducing Stroke-Associated Pneumonia: an Investigator-initiated, Multicenter, Randomized, Double-blind, Sham-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2025 (Anticipated)
    Study Completion Date
    September 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Capital Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Verifying whether remote ischemic adaptation can reduce the occurrence of stroke related pneumonia in acute stroke patients within 24 hours of onset
    Detailed Description
    Verifying whether remote ischemic adaptation can reduce the occurrence and safety of stroke related pneumonia in acute stroke patients within 24 hours of onset

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1650 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Remote ischemic conditioning (RIC) -200mmHg and best medical management
    Arm Title
    Sham group
    Arm Type
    Sham Comparator
    Arm Description
    Remote ischemic conditioning (RIC) -60mmHg and best medical management
    Intervention Type
    Device
    Intervention Name(s)
    Remote ischemic conditioning
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Sham remote ischemic conditioning
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Stroke-associated pneumonia
    Description
    Stroke-associated pneumonia incidence rate
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Physician diagnosed pneumonia
    Description
    Physician diagnosed pneumonia incidence rate
    Time Frame
    7 days
    Title
    Physician diagnosed pneumonia
    Description
    Physician diagnosed pneumonia incidence rate
    Time Frame
    8-90 days
    Title
    Modified Rankin scale 0-1
    Description
    defined by 0-1 of the modified Rankin Scale (mRS)
    Time Frame
    90 days after the onset of symptoms
    Title
    Modified Rankin scale 0-2
    Description
    defined by 0-2 of the modified Rankin Scale (mRS)
    Time Frame
    90 days
    Title
    Modified Rankin scale
    Description
    Shift analysis
    Time Frame
    90 days
    Title
    EQ-5D-5L
    Description
    The score of EQ-5D-5L
    Time Frame
    90 days
    Title
    NIHSS stroke scale
    Description
    The score of NIHSS stroke scale
    Time Frame
    24 hours
    Title
    NIHSS stroke scale
    Description
    The score of NIHSS stroke scale
    Time Frame
    7 days
    Title
    Urinary tract infections
    Description
    Urinary tract infections incidence rate
    Time Frame
    7 days
    Title
    Infections
    Description
    Infections incidence rate
    Time Frame
    7 days
    Title
    All-cause mortality
    Description
    All-cause mortality incidence rate
    Time Frame
    90 days
    Title
    Inpatient days
    Description
    Total inpatient days
    Time Frame
    90 days
    Other Pre-specified Outcome Measures:
    Title
    Spots of skin bleeding within 7 days
    Description
    Number of subjects who have skin bleeding points within 7 days
    Time Frame
    7 days
    Title
    Red or swollen arms within 7 days
    Description
    Number of subjects who have red or swollen arms within 7 days
    Time Frame
    7 days
    Title
    Dizziness within 7 days
    Description
    Number of subjects who have dizziness within 7 days
    Time Frame
    7 days
    Title
    Nausea within 7 days
    Description
    Number of subjects who have nausea within 7 days
    Time Frame
    7 days
    Title
    Palpitations within 7 days.
    Description
    Number of subjects who have palpitations within 7 days.
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age≥18 years old; 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: During the screening period, body temperature ≥ 38 ℃; 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xunming Ji, M.D. Ph.D
    Phone
    861013120136877
    Email
    jixunming@vip.163.com; 1730812302@qq.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lina Jia, M.D.
    Phone
    +8615901588600
    Email
    1730812302@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chuanjie Wu, M.D.
    Organizational Affiliation
    Xuanwu Hospital of Capital Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25612858
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26343840
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27733675
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22664787
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21738161
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17255542
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25176179
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Remote Ischemic Conditioning for Stroke-associated Pneumonia

    We'll reach out to this number within 24 hrs