Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 22 - 82 |
| Updated: | 4/21/2016 |
| Start Date: | February 2013 |
| End Date: | August 2015 |
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
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.
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.
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.
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.
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.
We found this trial at
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