Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization

NCT01778855 | Terminated Phase 2 Results DMC

• 2 other identifiers: HASTIERR01NS077706
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

stroke; hypothermia; thrombolysis; imaging; collateral circulation; recanalization; reperfusion

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 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. TIMI is cored per published definition. Additional data for secondary analyses were not acquired to permit analyses.

  36 hours

Study Arms (2)

Normothermia

ACTIVE COMPARATOR

IV t-PA and normothermia

Other: IV t-PA and normothermia

Hypothermia

ACTIVE COMPARATOR

IV t-PA and hypothermia

Device: IV-tPA and hypothermia

Interventions

IV t-PA and normothermia OTHER

Also known as: t-PA as standard of care and normothermia

Normothermia

IV-tPA and hypothermia DEVICE

Also known as: Hypothermia is induced using the Celsius Control™ System and IV-tPA administered

Hypothermia

Eligibility Criteria

• Age: 22 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (3)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, San Diego

San Diego, California, 92093, United States

Location

Intercoastal Medical Group

Sarasota, Florida, 34232, United States

Location

Related Publications (2)

• 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. doi: 10.1016/j.jstrokecerebrovasdis.2005.01.001.

  PMID: 17904009 BACKGROUND

• 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.

  PMID: 20724711 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Hypothermia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Early termination of ancillary study leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: David S Liebeskind, MD
• Organization: UCLA

dliebeskind@mednet.ucla.edu

310-794-6379

Study Officials

• David S Liebeskind, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 29, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 13, 2017
• Results First Posted: April 13, 2017

Record last verified: 2017-03

Locations

US (3)