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

Capital Medical University

Status: Not yet enrolling

Conditions: Acute Ischemic Stroke

Treatments: Procedure: Hypothermia with intrajugular cooling

Study type: Interventional

Funder types: Other

Identifiers

NCT05488392

PICNIC

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Intrajugular cooling group

Experimental group

Description:

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

Treatment:

Procedure: Hypothermia with intrajugular cooling