NCT00227448

CompletedPhase 2

Induced Hypertension for Acute Ischemic Stroke

Johns Hopkins University Source

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Other study identifiers

Sponsor study identifier

R01-NS-042607-1

Secondary identifiers

R01NS042607

NIH

Study Type

interventional

Reported enrollment (type unavailable)

60

Locations

1 country

Sites

2

Timeline

Study Start

June 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

April 2005

Date type not reported

This date has not been verified as actual or estimated.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 60 participants
Study completion date: April 2005
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2003
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
April 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 26, 2005
Actual (reported)
First Posted
September 28, 2005
Actual (reported)

Last Updated: April 3, 2008
Status Verified: April 2008
Last Update Submitted: April 1, 2008

Conditions

Acute Ischemic Stroke

Keywords

IschemicStroke

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 salineDrug

intravenous phenylephrineDrug

intravenous levophedDrug

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

National Institutes of Health (NIH)
NIHcollaborator
Johns Hopkins University
Otherlead

Study Sites (2)

University of Maryland Medical Systems

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

MeSH Terms

Conditions

Ischemic StrokeIschemiaStroke

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines

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 2003

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

April 2005

Date type not reported

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Phase 2Terminated

NCT00499902

Phase 2 Proof-of-Concept Study of the Safety and Efficacy of Alfimeprase to Rapidly Open Arteries and Restore Brain Function Following a Stroke

Phase 2Terminated

NCT00044057

A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)

Phase 2Completed

SYFa352bf979e134f0bb7ac169f6649e680

A multicentre study evaluating the safety of reperfusion thrombolytic therapy with intravenous recombinant tissue plasminogen activator (rtPA) for ischaemic stroke in patients on the non-vitamin K antagonist oral anticoagulant after reversing anticoagulant activity with a specific antidote.

Phase 2Recruiting

oral midodrineDrug

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.
+8 more criteria

Contact the study team to confirm eligibility.

Amino Alcohols

Alcohols

Organic Chemicals

Amines

This date has not been verified as actual or estimated.

Last Updated

April 3, 2008

Record last verified: 2008-04

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00227448
Data provider: ClinicalTrials.gov
Source updated: 2008-04-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:01 UTC

Locations

US(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations