Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization

NCT ID: NCT01778855

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-08-31

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Normothermia

IV t-PA and normothermia

Group Type: ACTIVE_COMPARATOR

IV t-PA and normothermia

Intervention Type: OTHER

Hypothermia

IV t-PA and hypothermia

Group Type: ACTIVE_COMPARATOR

IV-tPA and hypothermia

Intervention Type: DEVICE

Interventions

IV t-PA and normothermia

Intervention Type: OTHER

IV-tPA and hypothermia

Intervention Type: DEVICE

Other Intervention Names

t-PA as standard of care and normothermia; 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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 82 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

David Liebeskind

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David S Liebeskind, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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

Countries

United States

References

Lyden PD, Allgren RL, Ng K, Akins P, Meyer B, Al-Sanani F, Lutsep H, Dobak J, Matsubara BS, Zivin J. Intravascular Cooling in the Treatment of Stroke (ICTuS): early clinical experience. J Stroke Cerebrovasc Dis. 2005 May-Jun;14(3):107-14. doi: 10.1016/j.jstrokecerebrovasdis.2005.01.001.

Reference Type: BACKGROUND

PMID: 17904009 (View on PubMed)

Hemmen TM, Raman R, Guluma KZ, Meyer BC, Gomes JA, Cruz-Flores S, Wijman CA, Rapp KS, Grotta JC, Lyden PD; ICTuS-L Investigators. Intravenous thrombolysis plus hypothermia for acute treatment of ischemic stroke (ICTuS-L): final results. Stroke. 2010 Oct;41(10):2265-70. doi: 10.1161/STROKEAHA.110.592295. Epub 2010 Aug 19.

Reference Type: BACKGROUND

PMID: 20724711 (View on PubMed)

Other Identifiers

R01NS077706

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HASTIER

Identifier Type: -

Identifier Source: org_study_id