Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization
Stopped early · Phase 2/Phase 3
Conditions studied: Acute Ischemic Stroke
In brief
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.
Key facts
- Study ID
- NCT01778855
- Run by
- University of California, Los Angeles
- People needed
- 6
- Starts
- 2013-02-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2017-04-13
Who can join
Age: 22 and older, up to 82. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.