Stroke, Acute Ischemic
Conditions
Keywords
endovascular thrombectomy, hypothermia, large vessel occlusion, randomized controlled trial
Brief 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 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.
Interventions
PROCEDUREhypothermia
In this trial, intra-arterial select cooling infusion is used to reduce brain tissue temperature to 33-35°C.
PROCEDUREthrombectomy
Thrombectomy includes treatment with stent retrievers and/or thromboaspiration, balloon angioplasty, stenting, intra-arterial thrombolysis, or the various combinations of these approaches.
Sponsors
Xiangtan Central Hospital
Xinqiao Hospital of Chongqing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥ 18 years or more; 2. acute ischemic stroke within 24 hours from onset to randomization; 3. NIHSS ≥6 points before randomization; 4. Internal carotid artery, or the middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA/DSA; 5. Baseline ASPECTS score ≥ 3 and ≤8, or cerebral infarction core volume \< 100ml; 6. The patient decides to undergo endovascular therapy; 7. The patient or patient's representative signs a written informed consent form.
Exclusion criteria
1. CT or MR evidence of hemorrhage; 2. Currently pregnant or lactating (women patients); 3. Allergy to radiographic contrast agents, or nitinol devices; 4. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel; 5. Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation); 6. Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; 7. Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis; 8. Brain tumors with mass effect (except meningiomas) that are radiographically pleasant; 9. Intracranial aneurysm, arteriovenous malformation; 10. Any terminal illness with life expectancy less than 6 months; 11. Participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin scale score (mRS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Excellent outcome | 90 days post-randomization | Score of 0-1 on the modified Rankin scale |
| Functional independence | 90 days post-randomization | Score of 0-2 on the modified Rankin scale |
| Moderate outcome | 90 days post-randomization | Score of 0-3 on the modified Rankin scale |
| Early neurological improvement | 72 hours post-randomization | Compared with baseline NIHSS, the 72h NIHSS score is reduced by 8 points or more, or the 72h NIHSS is 0\ 1 point |
| EQ-5D-5L scale score | 90 days post-randomization | 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. |
| Other serious adverse events | 90 days post-randomization | — |
| Successful reperfusion at final angiogram | At the end of angiography or procedure | Successful reperfusion was defined as grade 2b to 3 on the extended Thrombectomy in the Cerebral Ischemia system. |
| Complications related to operation and device | 90 days post-randomization | vasospasm, arterial rupture, arterial dissection, vascular puncture point complications, etc. |
| Reperfusion on follow-up CT or MR angiography | 48 hours post-randomization | — |
| Incidence of symptomatic intracranial hemorrhage (SICH) | 48 hours post-randomization | using Heidelberg criteria to assess SICH |
| incidence of any intracranial hemorrhage (any ICH) | 48 hours post-randomization | — |
| 90-day mortality | 90 days post-randomization | — |
| Difference of hematocrit between baseline and 24-hour post-randomization | 24-hour post-randomization | — |
| Non-hemorrhagic serious adverse event rate | 90 days post-randomization | including pneumonia, respiratory failure, circulatory failure, cerebral herniation, secondary epilepsy, sepsis, renal failure, acute coronary syndrome, venous thrombosis, etc. |
| Difference between baseline and within 48h after procedure of infarction core volume (ml) | 48 hours post-randomization | — |
Contacts
Primary ContactGuangxiong Yuan, M.S.
Outcome results
None listed