Stroke, Acute IschemicCOOLINGNCT06109376
Role of Hypothermia in Endovascular Stroke Thrombectomy
A study testing hypothermia and thrombectomy in people with Stroke, Acute Ischemic, run by Xinqiao Hospital of Chongqing.
Trial summary
Reducing or suspending the increase of the infarcted core, i.e., "freezing" the ischemic penumbra, may help improve the efficacy of mechanical thrombectomy. Hypothermia effectively reduces the metabolic level of brain tissue, may prolong the time window for recanalization therapy, and its multi-target therapeutic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic
- What is being tested?
- hypothermia and thrombectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years or more;
- acute ischemic stroke within 24 hours from onset to randomization;
- NIHSS ≥6 points before randomization;
- Internal carotid artery, or the middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA/DSA;
- Baseline ASPECTS score ≥ 3 and ≤8, or cerebral infarction core volume < 100ml;
- The patient decides to undergo endovascular therapy;
- The patient or patient's representative signs a written informed consent form.
Who cannot join
- CT or MR evidence of hemorrhage;
- Currently pregnant or lactating (women patients);
- Allergy to radiographic contrast agents, or nitinol devices;
- Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
- Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);
- Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
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- Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
- Brain tumors with mass effect (except meningiomas) that are radiographically pleasant;
- Intracranial aneurysm, arteriovenous malformation;
- Any terminal illness with life expectancy less than 6 months;
- Participating in other clinical trials.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Endovascular Thrombectomy With Versus Without Hypothermia in Acute Large Vessel Occlusion Stroke: a Randomized Controlled Trial
Reducing or suspending the increase of the infarcted core, i.e., "freezing" the ischemic penumbra, may help improve the efficacy of mechanical thrombectomy. Hypothermia effectively reduces the metabolic level of brain tissue, may prolong the time window for recanalization therapy, and its multi-target therapeutic effect make it one of the most promising neuro-protection approach.
In recent years, hypothermia has been increasingly used to treat acute ischemic stroke. However, its role in acute ischemic stroke is unclear.
The objective of this trial is to investigate whether hypothermia combined with endovascular thrombectomy could add additional benefit without increasing the risk of adverse events such as pneumonia, intracerebral hemorrhage, and mortality.
- Conditions
- Stroke, Acute Ischemic
- Being tested
- hypothermia, thrombectomy
- Keywords
- endovascular thrombectomy, hypothermia, large vessel occlusion, randomized controlled trial
- 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.
hypothermiaProcedure or surgery
In this trial, intra-arterial select cooling infusion is used to reduce brain tissue temperature to 33-35°C.
thrombectomyProcedure or surgery
Thrombectomy includes treatment with stent retrievers and/or thromboaspiration, balloon angioplasty, stenting, intra-arterial thrombolysis, or the various combinations of these approaches.
| Study group | Role | What they receive |
|---|---|---|
| Hypothermia | Experimental | Patients in Hypothermia group received hypothermia combined with endovascular thrombectomy. Receives: Procedure: hypothermia; Procedure: thrombectomy |
| Control | Active comparator | Patients in Control group received endovascular thrombectomy alone. Receives: Procedure: thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin scale score (mRS)
Modified Rankin scale score (mRS): scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
Measured: 90 days post-randomization
Secondary outcomes (15)
Excellent outcome
Score of 0-1 on the modified Rankin scale
Measured: 90 days post-randomization
Functional independence
Score of 0-2 on the modified Rankin scale
Measured: 90 days post-randomization
Moderate outcome
Score of 0-3 on the modified Rankin scale
Measured: 90 days post-randomization
Early neurological improvement
Compared with baseline NIHSS, the 72h NIHSS score is reduced by 8 points or more, or the 72h NIHSS is 0~1 point
Measured: 72 hours post-randomization
EQ-5D-5L scale score
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: 90 days post-randomization
Successful reperfusion at final angiogram
Successful reperfusion was defined as grade 2b to 3 on the extended Thrombectomy in the Cerebral Ischemia system.
Measured: At the end of angiography or procedure
Difference between baseline and within 48h after procedure of infarction core volume (ml)
Measured: 48 hours post-randomization
Reperfusion on follow-up CT or MR angiography
Measured: 48 hours post-randomization
Incidence of symptomatic intracranial hemorrhage (SICH)
using Heidelberg criteria to assess SICH
Measured: 48 hours post-randomization
incidence of any intracranial hemorrhage (any ICH)
Measured: 48 hours post-randomization
90-day mortality
Measured: 90 days post-randomization
Difference of hematocrit between baseline and 24-hour post-randomization
Measured: 24-hour post-randomization
Non-hemorrhagic serious adverse event rate
including pneumonia, respiratory failure, circulatory failure, cerebral herniation, secondary epilepsy, sepsis, renal failure, acute coronary syndrome, venous thrombosis, etc.
Measured: 90 days post-randomization
Complications related to operation and device
vasospasm, arterial rupture, arterial dissection, vascular puncture point complications, etc.
Measured: 90 days post-randomization
Other serious adverse events
Measured: 90 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Acute IschemicStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangtan Central Hospital
- Responsible party
- Principal investigator, Zhongming Qiu, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109376
- Sponsor's protocol ID
- COOLING
- Acronym
- COOLING
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, and Analytic Code will be shared after approval of a proposal from principal investigator 3 years after the trial results are revealed.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Endovascular Thrombectomy With Versus Without Hypothermia in Acute Large Vessel Occlusion Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06109376
- Acronym / sponsor ID
- COOLING / COOLING
- Conditions
- Stroke, Acute Ischemic
- Keywords
- endovascular thrombectomy, hypothermia, large vessel occlusion, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- Xiangtan Central Hospital
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 31 Oct 2023 (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.
Reducing or suspending the increase of the infarcted core, i.e., "freezing" the ischemic penumbra, may help improve the efficacy of mechanical thrombectomy. Hypothermia effectively reduces the metabolic level of brain tissue, may prolong the time window for recanalization therapy, and its multi-target therapeutic effect make it one of the most promising neuro-protection approach.
In recent years, hypothermia has been increasingly used to treat acute ischemic stroke. However, its role in acute ischemic stroke is unclear.
The objective of this trial is to investigate whether hypothermia combined with endovascular thrombectomy could add additional benefit without increasing the risk of adverse events such as pneumonia, intracerebral hemorrhage, and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothermia | Experimental | Procedure: hypothermia, Procedure: thrombectomyPatients in Hypothermia group received hypothermia combined with endovascular thrombectomy. |
| Control | Active comparator | Procedure: thrombectomyPatients in Control group received endovascular thrombectomy alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥ 18 years or more;
- acute ischemic stroke within 24 hours from onset to randomization;
- NIHSS ≥6 points before randomization;
- Internal carotid artery, or the middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA/DSA;
- Baseline ASPECTS score ≥ 3 and ≤8, or cerebral infarction core volume < 100ml;
Key exclusion criteria (11 listed)
- CT or MR evidence of hemorrhage;
- Currently pregnant or lactating (women patients);
- Allergy to radiographic contrast agents, or nitinol devices;
- Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
- Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);
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 |
|---|---|---|
| hypothermiaIn this trial, intra-arterial select cooling infusion is used to reduce brain tissue temperature to 33-35°C. | Procedure or surgery | Hypothermia |
| thrombectomyThrombectomy includes treatment with stent retrievers and/or thromboaspiration, balloon angioplasty, stenting, intra-arterial thrombolysis, or the various combinations of these approaches. | Procedure or surgery | Control, Hypothermia |
Primary outcome
Modified Rankin scale score (mRS)
Time frame: 90 days post-randomization
Modified Rankin scale score (mRS): scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
15 secondary outcomes
Excellent outcome
Time frame: 90 days post-randomization
Functional independence
Time frame: 90 days post-randomization
Moderate outcome
Time frame: 90 days post-randomization
Early neurological improvement
Time frame: 72 hours post-randomization
EQ-5D-5L scale score
Time frame: 90 days post-randomization
Successful reperfusion at final angiogram
Time frame: At the end of angiography or procedure
Difference between baseline and within 48h after procedure of infarction core volume (ml)
Time frame: 48 hours post-randomization
Reperfusion on follow-up CT or MR angiography
Time frame: 48 hours post-randomization
Incidence of symptomatic intracranial hemorrhage (SICH)
Time frame: 48 hours post-randomization
incidence of any intracranial hemorrhage (any ICH)
Time frame: 48 hours post-randomization
90-day mortality
Time frame: 90 days post-randomization
Difference of hematocrit between baseline and 24-hour post-randomization
Time frame: 24-hour post-randomization
Non-hemorrhagic serious adverse event rate
Time frame: 90 days post-randomization
Complications related to operation and device
Time frame: 90 days post-randomization
Other serious adverse events
Time frame: 90 days post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, and Analytic Code will be shared after approval of a proposal from principal investigator 3 years after the trial results are revealed.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing hypothermia and thrombectomy in people with Stroke, Acute Ischemic, run by Xinqiao Hospital of Chongqing.
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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 31 Oct 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guangxiong Yuan, M.S. (18973223018, yuanguangxiong74@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin scale score (mRS) (time frame: 90 days post-randomization). 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 31 Oct 2023.