A Trial of Intravascular Hypothermia Therapy in Acute Ischemic Stroke Patients

NCT04695236 | Unknown DMC

• 1 other identifier: ASPIRE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Acute ischemic stroke (AIS) has been one of the major causes of global mortality and morbidity. The superiority of endovascular therapy (EVT) over standard medical therapy in treating AIS due to large vessel occlusion (LVO) in the anterior circulation has been widely accepted. However, a critical concern is that even with an extremely high rate of successful recanalization (the modified thrombolysis in cerebral infarction \[mTICI\] score 2b-3) around 90%, nearly half of the patients failed to benefit from EVT. So, adjunctive therapy of EVT for neuroprotection is required. From the previous domestic and foreign literatures, hypothermia can prevent and treat secondary injury caused by ischemia-reperfusion injury and cerebral edema of acute cerebral ischemia, so as to achieve the role of neuroprotection. In this study, intravascular cooling was performed as soon as possible with careful temperature control in patients receiving thrombectomy. The temperature was controlled at 33° C for 48-72 hours. This parallel controlled study is to systematically evaluate the feasibility and safety of adjunctive therapy using early intravascular hypothermia in AIS patients receiving mechanical thrombectomy. The results will clarify a potential modality for neuroprotection and hopefully provide new evidence in improving patient prognosis.

Conditions

Hypothermia; Reperfusion Injury; Ischemic Stroke; Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Intracranial hemorrhage conversion rate

  ICH

  7 days after thrombectomy operation or discharge

Secondary Outcomes (7)

• Modified Rankin scale (mRS)

  90 days

• The rate of functional independency (mRS 0-2)

  90 days

• The rate of mortality (mRS 6)

  90 days

• NIHSS

  24 hours, 7 days or discharge

• Rate of symptomatic intracranial hemorrhage (sICH)

  7 days after thrombectomy operation or discharge

Other Outcomes (1)

• Rate of any major adverse events

  7 days

Study Arms (2)

Study group

EXPERIMENTAL

Study Group: Intravascular hypothermia therapy group ZOLL Intravascular Temperature Management system, Quattro catheter will be used in study group

Device: ZOLL Intravascular Temperature Management system, Quattro catheter

Control group

PLACEBO COMPARATOR

Control group: Without intravascular hypothermia therapy group ZOLL Intravascular Temperature Management system, Quattro catheter will not be used in control group

Other: Standard Treatment

Interventions

ZOLL Intravascular Temperature Management system, Quattro catheter DEVICE

ZOLL Intravascular Temperature Management system, Quattro catheter

Study group

Standard Treatment OTHER

Standard Treatment for Ischemic Strokre

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years old
• Clinical signs consistent with acute ischemic stroke with large vessel occlusion in the anterior circulation (internal carotid artery, middle cerebral artery M1 or M2 segment)
• ASPECTS score 0-10
• Arterial puncture could be performed within 24 hours from symptom onset or LKN
• Baseline NIHSS (NIHSS) score prior to randomization ≥ 10 and NIHSS 1a ≥ 1
• Candidate for endovascular thrombectomy therapy in accordance with best practices per AHA standard stroke guidelines meeting all labeling requirements for EVT in the trial
• Successful recanalization of occluded vessel (mTICI 2b-3) after EVT
• No intracranial hemorrhage postoperative CT examinations immediately after recanalization. If the subject' recanalization of vessel could not achieve mTICI 2b-3, the subject could not enter the per-protocol analysis and will separate another group
• Informed consent form signed by subjects or their legal guardian

You may not qualify if:

• Subject who suffer serious infection (e.g. sepsis) or multiple organ failure
• Known presence of an IVC filter
• End stage renal disease on hemodialysis
• Known hypersensitivity to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics
• Known hypersensitivity to the components of the medical device
• Any known history of the following conditions: bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, will refuse blood transfusions or contraindication to heparin; history of genetically confirmed hypercoagulable syndrome
• Use of warfarin with INR \> 3
• Hemodynamically significant cardiac dysrhythmias (eg. QTc interval \>450 msec, bradycardia (heart rate less than 50), Mobitz Type II second degree AV block (or higher AV block), and severe ventricular dysrhythmias (sustained VT or VF)) which cause significant hypotension (SBP ≤ 120 mmHg requiring more than two pressor medications)
• Platelet count\<40×10\^9/L
• Blood glucose concentration \<2.7 or \> 22.2 mmol/L
• Hypertension uncontrollable by drug treatment (systolic blood pressure≥185 mmHg or diastolic blood pressure≥110mmhg)
• Expected life expectancy\<6 months
• Temperature \< 35°C on admission to Emergency Department
• With a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g., dementia or mental illness)
• Subject participating in a study involving an investigational drug or device that would impact the current study

Sponsors & Collaborators

• jiaoliqun: lead

Study Sites (1)

Xuanwu Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Hypothermia; Reperfusion Injury; Ischemic Stroke

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Liqun Jiao,MD, PhD

  Department of Neurosurgery & Interventional Neuroradiology Xuanwu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liqun Jiao,MD, PhD

CONTACT

13911224991; liqunjiao@sina.cn

Xin Qu,MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessment by independent investigators
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 1, 2021
• First Posted: January 5, 2021
• Study Start: December 31, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 6, 2022

Record last verified: 2022-06

Locations

CN (1)