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

University of California, Los Angeles (UCLA)

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Acute Ischemic Stroke

Treatments

Device: IV-tPA and hypothermia

Other: IV t-PA and normothermia

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01778855

HASTIER

R01NS077706 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

22 to 82 years old

Volunteers

No Healthy Volunteers

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.