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Hypothermia With Intrajugular Cooling in Acute Ischemic Stroke Thrombectomy (PICNIC)

Primary Purpose

Acute Ischemic Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypothermia with intrajugular cooling
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring acute ischemic stroke, hypothermia, thrombectomy, intrajugular cooling

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-80 years;
  2. Acute ischemic stroke caused by unilateral internal carotid artery terminal segment/middle cerebral artery M1 segment occlusion;
  3. In line with the indications for mechanical thrombectomy without contraindications;
  4. Successful recanalization (mTICI 2b/3) after mechanical thrombectomy that confirmed by digital subtraction angiography;
  5. Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria:

  1. Suffering from cerebral venous system diseases such as cerebral venous thrombosis/stenosis/dysplasia;
  2. Suffering from heart diseases such as ventricular arrhythmia/myocardial infarction/congestive heart failure;
  3. Imaging examination after mechanical thrombectomy shows intracranial hemorrhage/contrast extravasation;
  4. Difficulty in reaching the designated position of the device used for intrajugular cooling;
  5. Difficulty in complying with intrajugular cooling or other conditions that the investigator considered inappropriate for inclusion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intrajugular cooling group

    Arm Description

    The safety and tolerability of hypothermia with intrajugular cooling will be investigated using 3+3 dose-escalation trial design.

    Outcomes

    Primary Outcome Measures

    Number of participants with major response
    Major response is any of the following: Cerebral venous system damage; Cerebral venous thrombosis; Huge hematoma at the puncture site requiring surgical intervention; Malignant arrhythmia within 24 hours; Cardiac arrest within 24 hours; Myocardial infarction within 24 hours; Congestive heart failure within 24 hours. In the 3 + 3 design, 3 subjects are recruited for a given intrajugular cooling dose level. The trial is stopped if ≥ 2 of 3 subjects at a given dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next dose level. Maximum tolerable dose will be the dose at the level before stopping of the trial. The schedule of advancing duration is 10 min, 15 min, 20 min, 25 min, and 30 min.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 3, 2022
    Last Updated
    August 3, 2022
    Sponsor
    Capital Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05488392
    Brief Title
    Hypothermia With Intrajugular Cooling in Acute Ischemic Stroke Thrombectomy
    Acronym
    PICNIC
    Official Title
    Safety and Tolerability of Intrajugular Cooling in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2022 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    February 1, 2024 (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
    Hypothermia with intrajugular cooling is a neuroprotective strategy that has been proven to minimize brain damage and maximize functional preservation in animal models of stroke. The purpose of this proof-of-concept study is to determine the safety and tolerability of intrajugular cooling in patients with acute ischemic stroke who are treated with mechanical thrombectomy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Ischemic Stroke
    Keywords
    acute ischemic stroke, hypothermia, thrombectomy, intrajugular cooling

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intrajugular cooling group
    Arm Type
    Experimental
    Arm Description
    The safety and tolerability of hypothermia with intrajugular cooling will be investigated using 3+3 dose-escalation trial design.
    Intervention Type
    Procedure
    Intervention Name(s)
    Hypothermia with intrajugular cooling
    Intervention Description
    Hypothermia with intrajugular cooling will be applied after successful recanalization of the culprit internal carotid artery/middle cerebral artery. The perfusion rate will be set at 30 ml/min. Low temperature saline will be infused into the internal jugular vein for 10 min, 15 min, 20 min, 25 min, and 30 min successively.
    Primary Outcome Measure Information:
    Title
    Number of participants with major response
    Description
    Major response is any of the following: Cerebral venous system damage; Cerebral venous thrombosis; Huge hematoma at the puncture site requiring surgical intervention; Malignant arrhythmia within 24 hours; Cardiac arrest within 24 hours; Myocardial infarction within 24 hours; Congestive heart failure within 24 hours. In the 3 + 3 design, 3 subjects are recruited for a given intrajugular cooling dose level. The trial is stopped if ≥ 2 of 3 subjects at a given dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next dose level. Maximum tolerable dose will be the dose at the level before stopping of the trial. The schedule of advancing duration is 10 min, 15 min, 20 min, 25 min, and 30 min.
    Time Frame
    Within 24 hours after hypothermia with intrajugular cooling

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-80 years; Acute ischemic stroke caused by unilateral internal carotid artery terminal segment/middle cerebral artery M1 segment occlusion; In line with the indications for mechanical thrombectomy without contraindications; Successful recanalization (mTICI 2b/3) after mechanical thrombectomy that confirmed by digital subtraction angiography; Written informed consent provided by the patients or their legal relatives. Exclusion Criteria: Suffering from cerebral venous system diseases such as cerebral venous thrombosis/stenosis/dysplasia; Suffering from heart diseases such as ventricular arrhythmia/myocardial infarction/congestive heart failure; Imaging examination after mechanical thrombectomy shows intracranial hemorrhage/contrast extravasation; Difficulty in reaching the designated position of the device used for intrajugular cooling; Difficulty in complying with intrajugular cooling or other conditions that the investigator considered inappropriate for inclusion.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xunming Ji, M.D.
    Phone
    010-83198952
    Email
    jixm@ccmu.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.

    Learn more about this trial

    Hypothermia With Intrajugular Cooling in Acute Ischemic Stroke Thrombectomy

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