Hypothermia With Intrajugular Cooling in Acute Ischemic Stroke Thrombectomy

Acute Ischemic Stroke Clinical Trial

— PICNIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05488392
• Other study ID #: PICNIC
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: August 2022
• Source: Capital Medical University
• Contact: Xunming Ji, M.D.
• Phone: 010-83198952
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: February 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 24 hours after hypothermia with intrajugular cooling