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Sponsors and Collaborators: |
University of Cincinnati National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00243906 |
The purpose of this study is to examine the effects of delivering recombinant tissue plasminogen activator (rt-PA) and ultrasound to the site of the blood clot blocking blood flow to the brain of stroke patients.
Condition | Intervention | Phase |
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Stroke |
Drug: recombinant tissue plasminogen activator Procedure: low-intensity ultrasound |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Interventional Management of Stroke (IMS) Study |
Estimated Enrollment: | 120 |
Study Start Date: | January 2003 |
The overall goal of Interventional Management of Stroke (IMS) study is to refine thrombolytic therapy for patients with acute ischemic stroke who can be treated within three hours of stroke onset.
This multi-center, non-randomized pilot study will provide preliminary data about the benefits and risks of combined intravenous (IV) and intra-arterial (IA) recombinant tissue plasminogen activator (rtPA) and low-intensity ultrasound energy in ischemic stroke patients with baseline NIHSSS >/= 10 in whom intravenous treatment can be started within three hours of stroke onset. rt-PA is a thrombolytic, clot-dissolving drug.
The primary objectives for the study are to obtain reliable estimates of the effectiveness and safety of a treatment approach combining IV/IA rt-PA and ultrasound for stroke patients; and to determine if the estimated effectiveness of combined IV/IA rt-PA at 3 months—as compared to the 3 month outcome of placebo-treated patients in the NINDS rt-PA Stroke Trial—warrants proceeding to a large, phase III randomized trial.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
CT Scan Exclusion Criteria:
Sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267 |
Principal Investigator: | Joseph P. Broderick, MD | University of Cincinnati |
Principal Investigator: | Thomas A. Tomsick, MD | University of Cincinnati |
Study ID Numbers: | R01NS39160 |
Study First Received: | October 24, 2005 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00243906 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
acute ischemic stroke stroke rt-PA thrombolytic recombinant tissue plasminogen activator |
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Tissue Plasminogen Activator Fibrinolytic Agents Cardiovascular Agents Ischemia |
Brain Diseases Cerebrovascular Disorders Fibrin Modulating Agents Brain Ischemia Brain Infarction Infarction Plasminogen |
Molecular Mechanisms of Pharmacological Action Cerebral Infarction Hematologic Agents Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Tissue Plasminogen Activator Fibrinolytic Agents Cardiovascular Agents |
Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Fibrin Modulating Agents Therapeutic Uses Brain Ischemia Cardiovascular Diseases Brain Infarction Plasminogen |