Acute Ischemic StrokePhase 2NCT00227448
Induced Hypertension for Acute Ischemic Stroke
A Phase 2 study testing intravenous saline, intravenous phenylephrine and intravenous levophed in people with Acute Ischemic Stroke, run by Johns Hopkins University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- intravenous saline, intravenous phenylephrine and intravenous levophed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2003to Apr 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Participation in other investigational trial within 30 days.
- Moderate to severe baseline disability (pre-stroke Rankin score of > 3), severe or terminal concurrent medical illness with expected survival of < 3 months, or other concurrent medical or psychiatric condition which may limit neurologic assessment or patient follow-up in the opinion of the investigator.
- Requirement for anticoagulation with IV heparin or warfarin in the first 48 hours after enrollment.
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
- Toxicology screen positive for cocaine.
- Intubated at time of enrollment.
- Mesenteric or peripheral vascular thrombosis.
- Profound hypoxia or hypercarbia as defined as a PaO2 level less than 50 or a PaCO2 level of greater than 60.
- Norepinephrine Exclusion Criteria- The patient will not receive Norepinephrine if the patient has any of the following: lack of sufficient vascular access (central line or peripheral line greater than 18 gauge is sufficient), hypersensitivity to norepinephrine products, severe hypertension as in 4.2.4 above, tachycardia defined as HR >100 for 10 minutes sustained, myocardial infarction, pulmonary edema, peripheral ischemia, or ventricular arrhythmias.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Medical Systems
Baltimore, Maryland
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- intravenous saline, intravenous phenylephrine, intravenous levophed, oral midodrine
- Keywords
- Ischemic, Stroke
- Medical subject headings
- Ischemic Stroke, Ischemia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous salineDrug
intravenous phenylephrineDrug
intravenous levophedDrug
oral midodrineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startJun 2003
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Robert Wityk, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227448
- Sponsor's protocol ID
- R01-NS-042607-1
- Other IDs
- R01NS042607
- Status last verified
- Apr 2008
- First submitted
- 26 Sep 2005
- Last updated
- 3 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induced Hypertension for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00227448
- Acronym / sponsor ID
- R01-NS-042607-1
- Conditions
- Acute Ischemic Stroke
- Keywords
- Ischemic, Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2003
- Study completion
- Apr 2005
- First posted
- 28 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous saline | Drug | – |
| intravenous phenylephrine | Drug | – |
| intravenous levophed | Drug | – |
| oral midodrine | Drug | – |
Primary outcome
NIHSS during the intervention and at 30 and 90 days
MRI at post intervention
3 secondary outcomes
Barthel Index at 30 and 90 days
Rankin at 30 and 90 days
MRI at 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wityk, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intravenous saline, intravenous phenylephrine and intravenous levophed in people with Acute Ischemic Stroke, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIHSS during the intervention and at 30 and 90 days. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2008.