Acute Ischemic StrokePICNICNCT05488392
Hypothermia With Intrajugular Cooling in Acute Ischemic Stroke Thrombectomy
A study testing Hypothermia with intrajugular cooling in people with Acute Ischemic Stroke, run by Capital Medical University.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Hypothermia with intrajugular cooling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Tolerability of Intrajugular Cooling in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Hypothermia with intrajugular cooling
- Keywords
- acute ischemic stroke, hypothermia, thrombectomy, intrajugular cooling
- Medical subject headings
- Ischemic Stroke, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothermia with intrajugular coolingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intrajugular cooling group | Experimental | The safety and tolerability of hypothermia with intrajugular cooling will be investigated using 3+3 dose-escalation trial design. Receives: Procedure: Hypothermia with intrajugular cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours after hypothermia with intrajugular cooling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488392
- Sponsor's protocol ID
- PICNIC
- Acronym
- PICNIC
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Intrajugular Cooling in Patients With Acute Ischemic Stroke After Mechanical Thrombectomy
- ClinicalTrials.gov ID
- NCT05488392
- Acronym / sponsor ID
- PICNIC / PICNIC
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, hypothermia, thrombectomy, intrajugular cooling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrajugular cooling group | Experimental | Procedure: Hypothermia with intrajugular coolingThe safety and tolerability of hypothermia with intrajugular cooling will be investigated using 3+3 dose-escalation trial design. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypothermia with intrajugular coolingHypothermia 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. | Procedure or surgery | Intrajugular cooling group |
Primary outcome
Number of participants with major response
Time frame: Within 24 hours after hypothermia with intrajugular cooling
Major response is any of the following: 1. Cerebral venous system damage; 2. Cerebral venous thrombosis; 3. Huge hematoma at the puncture site requiring surgical intervention; 4. Malignant arrhythmia within 24 hours; 5. Cardiac arrest within 24 hours; 6. Myocardial infarction within 24 hours; 7. 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: Yes. Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothermia with intrajugular cooling in people with Acute Ischemic Stroke, run by Capital Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji, M.D. (010-83198952, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with major response (time frame: Within 24 hours after hypothermia with intrajugular cooling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.