Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization

Phase 2

Terminated

• Conditions: Acute Ischemic Stroke
• Interventions: Other: IV t-PA and normothermia; Device: IV-tPA and hypothermia

• Registration Number: NCT01778855
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-29
• Study Start: 2013-02
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2017-01-11
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-01
• Last Update Submitted: 2017-03-01
• Results First Posted: 2017-04-13
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Eligible for inclusion in the ICTuS 2/3 trial.
• Diagnosis of MCA stroke, confirmed by M1 or M2 proximal MCA occlusion on CT/MRI angiography.

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Exclusion Criteria

• Kidney dysfunction of such severity as to preclude routine administration of contrast media for CT/MRI angiography or perfusion imaging. Severe kidney dysfunction is defined by the American College of Radiology recommendations for use of contrast media.
• Known adverse reaction or allergy to such contrast media.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normothermia	IV t-PA and normothermia	IV t-PA and normothermia
Hypothermia	IV-tPA and hypothermia	IV t-PA and hypothermia

Primary Outcome Measures

Name	Time	Method
Number of Participants With Recanalization	36 hours	To determine whether hypothermia alters recanalization with standard thrombolytic treatment with intravenous (IV) tissue plasminogen activator (tPA) for acute ischemic stroke in humans. The hypothesis is that hypothermia does not impair recanalization (opening of the artery). Recanalization will be measured with Thrombolysis in Myocardial Infarction (TIMI) score change from baseline angiography to 36 hour angiography. TIMI is cored per published definition.; Additional data for secondary analyses were not acquired to permit analyses.

Trial Locations

Locations (3)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

Intercoastal Medical Group; 🇺🇸 Sarasota, Florida, United States