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Sponsors and Collaborators: |
Johns Hopkins University National Institutes of Health (NIH) |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00227448 |
The ultimate goal of this multicenter, phase II study is to increase blood pressure until either a neurologic response is seen or a target mean arterial pressure of 30% above baseline is achieved. IV fluids, IV phenylephrine and/or IV norepinephrine are used to rapidly raise mean arterial pressure in a controlled manner as serial assessments of neurologic function are performed.
Condition | Intervention | Phase |
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Acute Ischemic Stroke |
Drug: intravenous saline Drug: intravenous phenylephrine Drug: intravenous levophed Drug: oral midodrine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Induced Hypertension for Acute Ischemic Stroke |
Estimated Enrollment: | 60 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | April 2005 |
This is a multicenter, pilot clinical trial. The primary outcome variables will be the presence or absence of improvement in NIHSS during treatment with induced hypertension and the number of adverse events. The secondary outcome variables will be final infarct size on MRI at 1 month and Barthel Index and Modified Rankin Scale at 3 months.
All patients fulfilling the inclusion and exclusion criteria and who are willing to participate will receive intervention to induce hypertension, including intravenous saline, phenylephrine (neosynephrine) or levophed, and possibly oral midodrine. Blood pressure will be increased to a maximum mean arterial pressure (MAP) that is 30% above the baseline MAP as measured in the emergency department. The acute phase of the study will last for 3-5 days (for responders) and all patients will be followed up at 1 and 3 months post stroke onset. All patients will undergo neurologic, cognitive, and physical examinations as well as serial MRI studies with diffusion and perfusion-weighted imaging.
Primary hypotheses will be measured using the National Institutes of Health Stroke Scale (NIHSS) and MRI. Improvement following induced hypertension will be measured by comparing NIHSS performed at multiple time points throughout the study. The ability to predict diffusion-perfusion mismatch will be determined by comparing MRI #1 and MRI #2. NIHSS and MRI will also be compared to determine if NIHSS correlates with reperfusion area on MRI.
The secondary hypothesis of improved long-term outcome will be measured using the Barthel Index, the modified Rankin Scale, and MRI/Flair at 1 and 3 months post stroke symptom onset.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
University of Maryland Medical Systems | |
Baltimore, Maryland, United States | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Robert Wityk, MD | Johns Hopkins University |
Study ID Numbers: | R01-NS-042607-1, R01-NS-042607 |
Study First Received: | September 26, 2005 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00227448 |
Health Authority: | United States: Institutional Review Board |
Ischemic Stroke |
Pseudoephedrine Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases Cerebrovascular Disorders Naphazoline Oxymetazoline |
Guaifenesin Phenylephrine Norepinephrine Midodrine Brain Ischemia Ephedrine Phenylpropanolamine Brain Infarction Infarction Hypertension |
Respiratory System Agents Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Sympathomimetics Cardiotonic Agents Nervous System Diseases Physiological Effects of Drugs Cardiovascular Agents Protective Agents |
Adrenergic Agonists Pharmacologic Actions Nasal Decongestants Mydriatics Pathologic Processes Autonomic Agents Therapeutic Uses Vasoconstrictor Agents Cardiovascular Diseases Peripheral Nervous System Agents |