Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization "HASTIER"

Completed

Phase 2/3 Results N/A

Trial Description

The primary objective of this Phase 2 HASTIER study, as an ancillary study to ICTuS 2, is to compare key imaging measurements for serial changes in recanalization and reperfusion between hypothermia and normothermia treatment arms as intermediate outcomes of treatment effect. Secondary exploratory analyses include imaging of the neurovascular impact of reperfusion with hypothermia and tPA, including blood-brain barrier changes or permeability, hemorrhagic transformation, and infarct growth.

Detailed Description

A prospective imaging ancillary study coincides with recruitment of ICTuS 2 by using currently available imaging tools at a subset of multicenter sites. HASTIER will evaluate therapeutic response with imaging outcome measures for recanalization and reperfusion. Key scientific objectives include the evaluation of hypothermia on benchmark recanalization and reperfusion rates in 120 cases of middle cerebral artery (MCA) stroke. Recanalization will be measured with Thrombolysis in Myocardial Infarction (TIMI) score change from baseline-36 hour CT/MRI angiography. Reperfusion will be measured with Tmax > 6s lesion volume change from baseline-36 hour CT/MRI perfusion imaging. Secondary outcomes will be measured with serial changes in permeability abnormalities derived from CT/MRI perfusion imaging, hemorrhagic transformation, and infarct growth from baseline-36 hours. Correlation of these imaging parameters with clinical outcomes will provide insight to accelerate research during these translational steps in hypothermia treatment for acute ischemic stroke.

Conditions

Interventions

  • IV t-PA and normothermia Other
    Other Names: t-PA as standard of care and normothermia
    ARM 1: Kind: Experimental
    Label: Normothermia
    Description: IV t-PA and normothermia
  • IV-tPA and hypothermia Device
    Other Names: Hypothermia is induced using the Celsius Controlâ„¢ System and IV-tPA administered
    ARM 1: Kind: Experimental
    Label: Hypothermia
    Description: IV t-PA and hypothermia

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Diagnostic
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Recanalization 36 hours No
Primary Reperfusion 36 hours No
Secondary Neurovascular impact of reperfusion with the combination of hypothermia and tPA. 36 hours No

Sponsors