NCT04695236

A Trial of Intravascular Hypothermia Therapy in Acute Ischemic Stroke Patients

Status unknown NA Last updated 6 June 2022

What this trial tests

NA trial testing ZOLL Intravascular Temperature Management system, Quattro catheter in Hypothermia in 80 participants. Status unknown.

Timeline

31 December 2020

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	jiaoliqun
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	80
Start date	31 December 2020
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across China

Drugs / interventions tested

• ZOLL Intravascular Temperature Management system, Quattro catheter
• Standard Treatment

Conditions studied

• Hypothermia — all drugs for Hypothermia →
• Reperfusion Injury — all drugs for Reperfusion Injury →
• Ischemic Stroke — all drugs for Ischemic Stroke →
• Thrombectomy — all drugs for Thrombectomy →

Sponsor

jiaoliqun

Who can join

Adults 18 to 80, any sex, with Hypothermia or Reperfusion Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cellular and Molecular Targets for Non-Invasive, Non-Pharmacological Therapeutic/Rehabilitative Interventions in Acute Ischemic Stroke.
   Onose G, Anghelescu A, Blendea D, Ciobanu V, et al · · 2022 · cited 57× · PMID 35055089 · DOI 10.3390/ijms23020907
2. Impact of immediate postrecanalization cooling on outcome in acute ischemic stroke patients with a large ischemic core: prospective cohort study.
   Bai X, Qu X, Nogueira RG, Chen W, et al · · 2024 · cited 9× · PMID 38668659 · DOI 10.1097/js9.0000000000001127