TerminatedPhase 2/3

Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization

United States6 participantsStarted 2013-02

Plain-language 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.

Who can participate

Age range22 Years – 82 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Participants With Recanalization

Timeframe: 36 hours

Trial details

NCT IDNCT01778855

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-08

Results submitted2017-01-11

View on ClinicalTrials.gov More Acute Ischemic Stroke trials