An Ancillary Imaging Study to the Intravascular Cooling in the Treatment of Stroke 2 (ICTuS 2) Trial, an NIH-funded Project on the Safety and Efficacy of Hypothermia Combined With Thrombolysis

Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization

Sponsors

Lead sponsor: University of California, Los Angeles

Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)

Source 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.

Overall Status Terminated
Start Date February 2013
Completion Date August 2015
Primary Completion Date August 2015
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants With Recanalization 36 hours
Enrollment 6
Condition
Intervention

Intervention type: Other

Intervention name: IV t-PA and normothermia

Arm group label: Normothermia

Other name: t-PA as standard of care and normothermia

Intervention type: Device

Intervention name: IV-tPA and hypothermia

Arm group label: Hypothermia

Other name: Hypothermia is induced using the Celsius Control™ System and IV-tPA administered

Eligibility

Criteria:

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.

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.

Gender: All

Minimum age: 22 Years

Maximum age: 82 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
David S Liebeskind, MD Principal Investigator University of California, Los Angeles
Location
facility
Cedars-Sinai Medical Center | Los Angeles, California, 90048, United States
University of California, San Diego | San Diego, California, 92093, United States
Intercoastal Medical Group | Sarasota, Florida, 34232, United States
Location Countries

United States

Verification Date

March 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of California, Los Angeles

Investigator full name: David Liebeskind

Investigator title: Professor of Neurology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Normothermia

Arm group type: Active Comparator

Description: IV t-PA and normothermia

Arm group label: Hypothermia

Arm group type: Active Comparator

Description: IV t-PA and hypothermia

Acronym HASTIER
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov