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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of California, Los Angeles
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Liebeskind, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01778855
First received: January 23, 2013
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Acute Ischemic Stroke
Other: IV t-PA and normothermia
Device: IV-tPA and hypothermia
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Recanalization [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
    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.

  • Reperfusion [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
    To determine whether hypothermia alters reperfusion 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 reperfusion (restoration of downstream flow) with thrombolysis. Reperfusion will be measured with Tmax >6s lesion volume change from baseline perfusion imaging to 36 hour perfusion imaging.


Secondary Outcome Measures:
  • Neurovascular impact of reperfusion with the combination of hypothermia and tPA. [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
    The neurovascular impact of reperfusion will be measured by serial changes in permeability abnormalities derived from the CT/MR perfusion imaging, incidence of hemorrhagic transformation and infarct growth from baseline to 36 hours.


Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   22 Years to 82 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778855

Contacts
Contact: David S Liebeskind, MD 310-794-6379 davidliebeskind@yahoo.com
Contact: Teresa Rzesiewicz, RN, BSN, PHN, MBA, CCRC 858-657-7185 trzesiewicz@ucsd.edu

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Patrick D Lyden, MD    310-423-5166    patrick.lyden@cshs.org   
Principal Investigator: Patrick D Lyden, MD         
University of California, San Diego Recruiting
San Diego, California, United States, 92093
Contact: Thomas M Hemmen, MD, PhD    858-657-7190      
Principal Investigator: Thomas M Hemmen, MD, PhD         
United States, Florida
Intercoastal Medical Group Recruiting
Sarasota, Florida, United States, 34232
Contact: Mauricia Concha, MD         
Principal Investigator: Mauricia Concha, MD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: David S Liebeskind, MD University of California, Los Angeles
  More Information

Publications:
Responsible Party: David Liebeskind, Professor of Neurology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01778855     History of Changes
Other Study ID Numbers: HASTIER, R01NS077706
Study First Received: January 23, 2013
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
stroke
hypothermia
thrombolysis
imaging
collateral circulation
recanalization
reperfusion

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Hypothermia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014