Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization

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

Patrocinadores

Patrocinador principal: University of California, Los Angeles

Colaborador: National Institute of Neurological Disorders and Stroke (NINDS)

Fuente University of California, Los Angeles
Resumen breve

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.

Descripción detallada

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.

Estado general Terminated
Fecha de inicio February 2013
Fecha de Terminación August 2015
Fecha de finalización primaria August 2015
Fase Phase 2/Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Number of Participants With Recanalization 36 hours
Inscripción 6
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: IV t-PA and normothermia

Etiqueta de grupo de brazo: Normothermia

Otro nombre: t-PA as standard of care and normothermia

Tipo de intervención: Device

Nombre de intervención: IV-tPA and hypothermia

Etiqueta de grupo de brazo: Hypothermia

Otro nombre: Hypothermia is induced using the Celsius Control™ System and IV-tPA administered

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 22 Years

Edad máxima: 82 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
David S Liebeskind, MD Principal Investigator University of California, Los Angeles
Ubicación
Instalaciones:
Cedars-Sinai Medical Center | Los Angeles, California, 90048, United States
University of California, San Diego | San Diego, California, 92093, United States
Intercoastal Medical Group | Sarasota, Florida, 34232, United States
Ubicacion Paises

United States

Fecha de verificación

March 2017

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: University of California, Los Angeles

Nombre completo del investigador: David Liebeskind

Título del investigador: Professor of Neurology

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Normothermia

Tipo: Active Comparator

Descripción: IV t-PA and normothermia

Etiqueta: Hypothermia

Tipo: Active Comparator

Descripción: IV t-PA and hypothermia

Acrónimo HASTIER
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Diagnostic

Enmascaramiento: Single (Outcomes Assessor)

Fuente: ClinicalTrials.gov