Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke
NCT Number: NCT06485427
Acronym: FOCUS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Ischemic Stroke|Hypothermia
Interventions: PROCEDURE: Selective Intra-arterial Cooling Infusion (IA-SCI)
Sponsor: Beijing Shijitan Hospital, Capital Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 258
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-03
Completion Date: 2026-08-01
Locations: 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

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.

Primary Outcome Measures: Distribution of Modified Rankin scale, the distribution of Modified Rankin scale (mRS) \[ranging from 0 (normal) to 6 (death)\], 90 ±7days
Secondary Outcome Measures: Percentage of functional independence (mRS scale 0-2), the percentage of mRS scale 0-2 (Modified Rankin scale \[ranging from 0 (normal) to 6 (death)\]), 90 ±7days|Percentage of favorable outcome (mRS scale 0-1), the percentage of mRS scale 0-1(Modified Rankin scale \[ranging from 0 (normal) to 6 (death)\]), 90 ±7days|Final infarction volume, 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)., 7±2 days/discharge|The changes of infarction volume, the changes of infarction volume between baseline and 7±2 days/discharge assessed by CT, 7±2 days/discharge|National Institute of Health stroke scale (NIHSS) score, National Institute of Health stroke scale (NIHSS) score \[ranging from 0 to 42 points, with higher numbers indicating greater severity\], 7±2 days/discharge|Barthel Index score, the Barthel Index score \[the sum of the score ranging from 0 to 100, with 100 being the most independent level of function\], 7±2 days/discharge|Rapid neurologic improvement, 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., 24±6 hours|Changes in ipsilateral tympanic membrane temperature, Changes in ipsilateral tympanic membrane temperature before and after intra-arterial cooling infusion in the IA-SCI group., during surgery.|Power spectral density (PSD) assessed by continuous electroencephalogram (EEG), PSD is estimated using Welch's periodogram from EEG., within 7±2 days/discharge|(delta+theta)/(alpha+beta) power ratio (DTABR) assessed by continuous electroencephalogram (EEG), DTABR is calculated using the absolute power for each of spectral band on EEG., within 7±2 days/discharge|Delta/alpha power ratio (DAR) assessed by continuous electroencephalogram (EEG), DAR is calculated using the absolute power for each of spectral band on EEG., within 7±2 days/discharge|Brain symmetry index (BSI) assessed by continuous electroencephalogram (EEG), BSI is calculated using the power values from both left and right hemispheres from EEG., within 7±2 days/discharge|Symptomatic intracranial hemorrhage, 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., 24±6 hours|Any intracranial hemorrhage, any intracranial hemorrhage assessed by CT, 24±6 hours|Intracranial arterial vasospasm after IA-SCI that requires further therapeutic intervention., Patients with vasospasm confirmed by DSA and requiring further therapeutic intervention, during operation|Proportion of subjects with pulmonary, urinary tract infection and gastroenteritis, 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., 7±2 days/discharge|Proportion of subjects with coagulation abnormalities, Defined as abnormal coagulation function, 24±6 hours|Proportion of subjects with electrolyte imbalance, Defined as any abnormal findings, including hypernatremia, hyponatremia, hyperkalemia, or hypokalemia., 24±6 hours|Changes in core temperature before and after intra-arterial cooling infusion in the IA-SCI group., Changes in rectal temperature before and after intra-arterial cooling infusion in the IA-SCI group., During operation|any death, any death, 90±7 days|other AE/SAE, other adverse events/ serious adverse events, 90±7 days