Induced Hypertension for Acute Ischemic Stroke

NCT00227448 | Completed Phase 2

• 2 other identifiers: R01-NS-042607-1R01NS042607
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Ischemic Stroke

Keywords

Ischemic; Stroke

Outcome Measures

Primary Outcomes (2)

• NIHSS during the intervention and at 30 and 90 days

• MRI at post intervention

Secondary Outcomes (3)

• Barthel Index at 30 and 90 days

• Rankin at 30 and 90 days

• MRI at 30 days

Interventions

intravenous saline DRUG

intravenous phenylephrine DRUG

intravenous levophed DRUG

oral midodrine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Current use of MAO inhibitors, tricyclic antidepressant medications, or cyclopropane or halothane anesthetic agents.
• Coma.
• Allergies or known contraindications to the use of IV phenylephrine, IV norepinephrine, sodium metabisulfite, or oral midodrine.
• Hemorrhage on initial MRI or CT or other structural lesion that might raise the risk of intracranial bleeding.
• Thrombocytopenia (plt \< 100 k), PTT \> 100 sec, INR \> 3.0 at time of treatment.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

University of Maryland Medical Systems

Baltimore, Maryland, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Ischemia; Stroke

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Robert Wityk, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: June 1, 2003
• Study Completion: April 1, 2005
• Last Updated: April 3, 2008

Record last verified: 2008-04

Locations

US (2)