Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke
- Conditions
- Acute Ischemic StrokeHypothermia
- Interventions
- Procedure: Selective Intra-arterial Cooling Infusion (IA-SCI)
- Registration Number
- NCT06485427
- Lead Sponsor
- Beijing Shijitan Hospital, Capital Medical University
- Brief Summary
This is a multicenter, randomized, controlled, subject- and assessor-blinded clinical trial. The research objective is to evaluate the safety and efficacy of selective intra-arterial cooling infusion combined with endovascular therapy in the treatment of acute anterior circulation large vessel occlusion stroke. This trial aims to enroll 258 subjects. Patients assigned to the control group will receive best medical management (BMM) and endovascular therapy (EVT). Those in the selective intra-arterial cooling infusion group (IA-SCI group) will undergo selective intra-arterial cold saline infusion, in addition to BMM and EVT. Subjects will be interviewed face-to-face at randomization, 24±6 hours, 48±6 hours after randomization, 7±2 days/discharge. Telephone interviews/ face-to face interviews will be performed at 30±3 days and 90±7 days after randomization. The primary outcome is the distribution of Modified Rankin Score at 90±7days after randomization.
- Detailed Description
Acute ischemic stroke (AIS) is the leading cause of death and disability in China. Randomized trials involving patients with acute stroke due to large-artery occlusion in the anterior circulation have shown a benefit of endovascular therapy (EVT). Although EVT achieves successful recanalization in over 80% of patients, only 46% of patients are functionally independent (mRS 0-2) after the intervention . Therefore, new ancillary therapeutic strategies are needed to further improve the clinical outcomes.
Therapeutic systemic hypothermia has been suggested to be one such potential approach offering a viable neuroprotective strategy. However, several adverse events associated with the systematic hypothermia treatment have been reported. Those offset the therapeutic benefits of systemic hypothermia. Selective intra-arterial cooling infusion (IA-SCI) targets precisely the ischemic brain tissue with the infusion of hypothermic solutions. This approach induces a state of mild hypothermia in the ischemic region without causing substantial drops in core body temperature, thereby minimizing the incidence of systemic side effects. Previous studies have shown that IA-SCI with cold saline combined with EVT in AIS is safe and feasible.
Hence, the investigators design a multicenter, randomized, controlled, subject- and assessor-blinded clinical trial. The objective of this trial is to further explore the safety and efficacy of selective intra-arterial cooling infusion combined with EVT in the treatment of acute anterior circulation large vessel occlusion stroke, and 258 subjects will be enrolled. Subjects assigned to the control group will receive best medical management (BMM) and endovascular therapy (EVT). Those in the selective intra-arterial cooling infusion group (IA-SCI group) will undergo selective intra-arterial cold saline infusion, in addition to BMM and EVT. Subjects will be interviewed face-to-face at randomization, 24±6 hours, 48±6 hours after randomization, 7±2 days/discharge. Telephone interviews/ face-to face interviews will be performed at 30±3 days and 90±7 days after randomization. The primary outcome is the distribution of Modified Rankin Score at 90±7days after randomization.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 258
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IA-SCI group Selective Intra-arterial Cooling Infusion (IA-SCI) Subjects randomized to the IA-SCI group will receive selective intra-arterial cooling infusion plus BMM and EVT.
- Primary Outcome Measures
Name Time Method Distribution of Modified Rankin scale 90 ±7days the distribution of Modified Rankin scale (mRS) \[ranging from 0 (normal) to 6 (death)\]
- Secondary Outcome Measures
Name Time Method Percentage of functional independence (mRS scale 0-2) 90 ±7days the percentage of mRS scale 0-2 (Modified Rankin scale \[ranging from 0 (normal) to 6 (death)\])
Percentage of favorable outcome (mRS scale 0-1) 90 ±7days the percentage of mRS scale 0-1(Modified Rankin scale \[ranging from 0 (normal) to 6 (death)\])
Final infarction volume 7±2 days/discharge A plain computed tomography (CT) scan will be performed. The infarct area is defined as the low-density area. The infarct area is semi-automatically delineated by the software. The infarct volume= the sum of the infarct area of each layer × layer thickness (5mm).
The changes of infarction volume 7±2 days/discharge the changes of infarction volume between baseline and 7±2 days/discharge assessed by CT
National Institute of Health stroke scale (NIHSS) score 7±2 days/discharge National Institute of Health stroke scale (NIHSS) score \[ranging from 0 to 42 points, with higher numbers indicating greater severity\]
Barthel Index score 7±2 days/discharge the Barthel Index score \[the sum of the score ranging from 0 to 100, with 100 being the most independent level of function\]
Rapid neurologic improvement 24±12 hours Rapid neurologic improvement is defined as a reduction of ≥8 on the National Institutes of Health Stroke Scale \[ranging from 0 to 42 points, with higher numbers indicating greater severity\] or National Institutes of Health Stroke Scale zero to one 24 hours after thrombectomy.
Changes in ipsilateral tympanic membrane temperature during surgery. Changes in ipsilateral tympanic membrane temperature before and after intra-arterial cooling infusion in the IA-SCI group.
Power spectral density (PSD) assessed by continuous electroencephalogram (EEG) within 7±2 days/discharge PSD is estimated using Welch's periodogram from EEG.
(delta+theta)/(alpha+beta) power ratio (DTABR) assessed by continuous electroencephalogram (EEG) within 7±2 days/discharge DTABR is calculated using the absolute power for each of spectral band on EEG.
Delta/alpha power ratio (DAR) assessed by continuous electroencephalogram (EEG) within 7±2 days/discharge DAR is calculated using the absolute power for each of spectral band on EEG.
Brain symmetry index (BSI) assessed by continuous electroencephalogram (EEG) within 7±2 days/discharge BSI is calculated using the power values from both left and right hemispheres from EEG.
Symptomatic intracranial hemorrhage 24±12 hours Defined as any intracranial hemorrhage accompanied by neurological deterioration (NIHSS score increased by more than 4 points compared with the lowest NIHSS score at enrollment or during hospitalization) or death caused by any cerebral hemorrhage according to the ECASS III study.
Any intracranial hemorrhage 24±12 hours any intracranial hemorrhage assessed by CT
Intracranial arterial vasospasm after IA-SCI that requires further therapeutic intervention. during operation Patients with vasospasm confirmed by DSA and requiring further therapeutic intervention
Proportion of subjects with pulmonary, urinary tract infection and gastroenteritis 7±2 days/discharge the proportion of patients with pulmonary, urinary tract infection and gastroenteritis according to the Centers for Disease Control and Prevention (CDC)/ National Healthcare Safety Network (NHSN) criteria.
Proportion of subjects with coagulation abnormalities 24±12 hours Defined as abnormal coagulation function
Proportion of subjects with electrolyte imbalance 24±12 hours Defined as any abnormal findings, including hypernatremia, hyponatremia, hyperkalemia, or hypokalemia.
Changes in core temperature before and after intra-arterial cooling infusion in the IA-SCI group. During operation Changes in rectal temperature before and after intra-arterial cooling infusion in the IA-SCI group.
any death 90±7 days any death
other AE/SAE 90±7 days other adverse events/ serious adverse events
Trial Locations
- Locations (9)
The Second Hospital and Clinical Medical School, Lanzhou University
🇨🇳Lanzhou, Gan Su, China
Department of Neurosurgery, Nanshi Hospital of Nanyang
🇨🇳Nanyang, He Nan, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiang Su, China
Peking University Internation Hospital
🇨🇳Beijing, China
Beijing Shijitan Hospital, Capital Medical University
🇨🇳Beijing, China
967 Hospital of the Joint Logistics Support Force of PLA
🇨🇳Dalian, China
Dalian Municipal Central Hospital
🇨🇳Dalian, China
The First Affiliated Hospital of Harbin Medical University
🇨🇳Ha'erbin, China
Affiliated Hospital of Inner Mongolia University for the Nationalities
🇨🇳Tongliao, China