Induced Hypertension for Acute Ischemic Stroke
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.
Acute Ischemic Stroke
Drug: intravenous saline
Drug: intravenous phenylephrine
Drug: intravenous levophed
Drug: oral midodrine
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Induced Hypertension for Acute Ischemic Stroke|
- NIHSS during the intervention and at 30 and 90 days
- MRI at post intervention
- Barthel Index at 30 and 90 days
- Rankin at 30 and 90 days
- MRI at 30 days
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227448
|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|