Induced Hypertension for Acute Ischemic Stroke
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Johns Hopkins University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- NIHSS during the intervention and at 30 and 90 days
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with acute ischemic stroke in whom treatment can be initiated within 12 hours of a clearly defined symptom onset. (If the patient awakens with a deficit, time of onset is considered the time the patient was last seen functioning normally.)
- •Age older then 18 years of age.
- •Measurable neurologic deficit other than isolated facial weakness, sensory loss or ataxia. NIHSS must be \> 4 points.
- •Head CT showing no evidence of intracranial hemorrhage or mass lesion which might increase the risk of bleeding.
- •Absence of ischemic changes on EKG (i.e. \> than 1mm ST segment elevation or depression in at least two contiguous leads, new T waves inversion in two leads).
- •No contraindication to MRI studies, including allergy to gadolinium.
Exclusion Criteria
- •History of unstable angina, any recent angina (defined as chest pain) in the past 3 months, recent myocardial infarction (less then 3 months), any history of ventricular arrhythmia, presence of left ventricular bundle branch block on EKG.
- •History of severe and symptomatic cardiac valvular disease.
- •History of congestive heart failure, dilated cardiomyopathy, hypertrophic obstructive cardiomyopathy, or known ejection fraction \< 25%.
- •Systolic blood pressure greater \> 200 mm Hg or MAP \> 120 mm HG when patient is initially monitored.
- •Serum creatinine greater then 2 mg/dl.
- •History of symptomatic peripheral vascular disease or Raynaud's syndrome.
- •Suspected seizure at the onset of stroke.
- •Treatment with IV tPA or other thrombolytic agent.
- •Massive stroke (\> 2/3 MCA territory) or any amount of midline shift due to cerebral edema on head CT.
- •Pregnancy
Outcomes
Primary Outcomes
NIHSS during the intervention and at 30 and 90 days
MRI at post intervention
Secondary Outcomes
- Barthel Index at 30 and 90 days
- Rankin at 30 and 90 days
- MRI at 30 days