PICNIC: Hypothermia With Intrajugular Cooling in Acute Ischemic Stroke Thrombectomy

Sponsor

Capital Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05488392

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Procedure: Hypothermia with intrajugular cooling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Tolerability of Intrajugular Cooling in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intrajugular cooling group The safety and tolerability of hypothermia with intrajugular cooling will be investigated using 3+3 dose-escalation trial design.	Procedure: Hypothermia with intrajugular cooling 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.

Arm

Intervention/Treatment

Experimental: Intrajugular cooling group

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

Procedure: Hypothermia with intrajugular cooling

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.

Outcome Measures

Primary Outcome Measures

Number of participants with major response [Within 24 hours after hypothermia with intrajugular cooling]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.