Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization

Acute Ischemic Stroke Clinical Trial

— HASTIER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778855
• Other study ID #: HASTIER
• Secondary ID: R01NS077706
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 23, 2013
• Last updated: November 30, 2015
• Start date: February 2013
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years to 82 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Hypothermia
• Stroke

Intervention

Other:
• IV t-PA and normothermia

Device:
• IV-tPA and hypothermia

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of California, San Diego	San Diego	California
United States	Intercoastal Medical Group	Sarasota	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recanalization	To determine whether hypothermia alters recanalization with standard thrombolytic treatment with intravenous (IV) tissue plasminogen activator (tPA) for acute ischemic stroke in humans. The hypothesis is that hypothermia does not impair recanalization (opening of the artery). Recanalization will be measured with Thrombolysis in Myocardial Infarction (TIMI) score change from baseline angiography to 36 hour angiography.	36 hours	No
Primary	Reperfusion	To determine whether hypothermia alters reperfusion with standard thrombolytic treatment with intravenous (IV) tissue plasminogen activator (tPA) for acute ischemic stroke in humans. The hypothesis is that hypothermia does not impair reperfusion (restoration of downstream flow) with thrombolysis. Reperfusion will be measured with Tmax >6s lesion volume change from baseline perfusion imaging to 36 hour perfusion imaging.	36 hours	No
Secondary	Neurovascular impact of reperfusion with the combination of hypothermia and tPA.	The neurovascular impact of reperfusion will be measured by serial changes in permeability abnormalities derived from the CT/MR perfusion imaging, incidence of hemorrhagic transformation and infarct growth from baseline to 36 hours.	36 hours	No