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Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization (HASTIER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01778855
Recruitment Status : Terminated
First Posted : January 29, 2013
Results First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
David Liebeskind, University of California, Los Angeles

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Other: IV t-PA and normothermia Device: IV-tPA and hypothermia Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : February 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Normothermia
IV t-PA and normothermia
 Other: IV t-PA and normothermia
Other Name: t-PA as standard of care and normothermia
Active Comparator: Hypothermia
IV t-PA and hypothermia
 Device: IV-tPA and hypothermia
Other Name: Hypothermia is induced using the Celsius Control™ System and IV-tPA administered


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Recanalization [ Time Frame: 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.



Eligibility Criteria
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Ages Eligible for Study:   22 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778855


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California, San Diego
San Diego, California, United States, 92093
United States, Florida
Intercoastal Medical Group
Sarasota, Florida, United States, 34232
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: David S Liebeskind, MD University of California, Los Angeles
More Information
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Publications:

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Responsible Party: David Liebeskind, Professor of Neurology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01778855    
Other Study ID Numbers: HASTIER
R01NS077706 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2013    Key Record Dates
Results First Posted: April 13, 2017
Last Update Posted: April 13, 2017
Last Verified: March 2017
Keywords provided by David Liebeskind, University of California, Los Angeles:
stroke
hypothermia
thrombolysis
imaging
 collateral circulation
recanalization
reperfusion
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Hypothermia
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Body Temperature Changes