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Interventional Management of Stroke (IMS) II Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00243906
Recruitment Status : Completed
First Posted : October 25, 2005
Last Update Posted : July 25, 2012
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Cincinnati

Brief Summary:
The purpose of this study is to examine the effects of delivering intra-arterial recombinant tissue plasminogen activator (rt-PA) and ultrasound to the site of the blood clot blocking blood flow to the brain of stroke patients.

Condition or disease Intervention/treatment Phase
Stroke Drug: Recombinant tissue plasminogen activator Procedure: Low-intensity ultrasound Phase 2

Detailed Description:

The overall goal of Interventional Management of Stroke (IMS II) study is to refine thrombolytic therapy for patients with acute ischemic stroke who can be treated within three hours of stroke onset.

This multi-center, non-randomized pilot study will provide preliminary data about the benefits and risks of combined intravenous (IV) and intra-arterial (IA) recombinant tissue plasminogen activator (rtPA) and low-intensity ultrasound energy in ischemic stroke patients with baseline NIHSSS >/= 10 in whom intravenous treatment can be started within three hours of stroke onset. rt-PA is a thrombolytic, clot-dissolving drug.

The primary objectives for the study are to obtain reliable estimates of the effectiveness and safety of a treatment approach combining IV/IA rt-PA and ultrasound for stroke patients; and to determine if the estimated effectiveness of combined IV/IA rt-PA at 3 months-as compared to the 3 month outcome of placebo-treated patients in the NINDS rt-PA Stroke Trial-warrants proceeding to a large, phase III randomized trial.

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Study Type : Interventional
Actual Enrollment : 81 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional Management of Stroke (IMS) II Study
Study Start Date : January 2003
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Intervention Details:
  • Drug: Recombinant tissue plasminogen activator
    Low-dose IV rt-PA (0.6 mg/kg) followed by delivery of additional IA rt-PA (up to 22 mg).
  • Procedure: Low-intensity ultrasound
    Delivery of additional IA rt-PA (up to 22 mg) in the setting of low-energy ultrasound via the EKOS microinfusion catheter at the site of IA occlusion in acute ischemic stroke patients with large strokes (NIHSS >/= 10) treated within 3 hours of symptoms onset.

Primary Outcome Measures :
  1. Primary Safety Endpoint [ Time Frame: 36 hours after completion of rt-PA infusion ]
    Development of intracerebral hematoma or hemorrhagic infarction with clinical deterioration likely to result in permanent disability or death, or other severe systemic bleeding complications such as groin hematoma, retroperitoneal hematoma, or gastrointestinal bleeding requiring transfusion of 3 units of blood replacement or major surgical intervention.

  2. Primary Angiographic Outcome [ Time Frame: 60 minutes after start of IA therapy ]
    The primary revascularization end point was complete (arterial occlusive lesion III) recanalization of the targeted arterial occlusion at 60 minutes after the start of IA rt-PA and ultrasound therapy,

  3. Primary Outcome Measure [ Time Frame: 3 months following treatment ]
    modified Rankin Score of 0 or 1

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age: 18 through 80 years (i.e., candidates must have had their 18th birthday, but not had their 81st birthday)
  • Initiation of intravenous rt-PA within 3 hours of onset of stroke symptoms. Time of onset is defined as the last time when the subject was witnessed to be at baseline (i.e., subjects who have stroke symptoms upon awakening will be considered to have their onset at beginning of sleep)
  • An NIHSSS >/= 10 at the time that intravenous rt-PA is begun

Exclusion Criteria:

  • History of stroke in the past 3 months
  • Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arteriovenous malformation
  • Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT scan is normal
  • Hypertension at time of treatment; systolic BP > 185 or diastolic > 110 mm Hg) or aggressive measures to lower blood pressure to below these limits are needed.
  • Presumed septic embolus
  • Presumed pericarditis, including pericarditis after acute myocardial infarction
  • Recent (within 30 days) surgery or biopsy of parenchymal organ
  • Recent (within 30 days) trauma, with internal injuries or ulcerative wounds
  • Recent (within 90 days) severe head trauma or head trauma with loss of consciousness
  • Any active or recent (within 30 days) hemorrhage
  • Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency or oral anticoagulant therapy with INR > 1.5 or institutionally equivalent prothrombin time
  • Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission
  • Baseline lab values: glucose < 50mg/dl or > 400mg/dl, platelets <100,000, or Hct <25
  • Subjects that require hemodialysis or peritoneal dialysis
  • Subjects who have received heparin within 48 hours must have a normal partial thromboplastin time (PTT) to be eligible
  • Subjects with an arterial puncture at a non-compressible site or a lumbar puncture in the previous 7 days
  • Subjects with a seizure at onset of stroke
  • Subjects with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
  • Other serious, advanced, or terminal illness
  • Any other condition that the investigator feels would pose a significant hazard to the subject if Activase (Alteplase) therapy is initiated
  • Current participation in another research drug treatment protocol; subject cannot start another experimental agent until after 90 days
  • Informed consent is not or cannot be obtained. For example, obtunded subjects are not automatically excluded from the study. However, if the next of kin or legal guardian (i.e., the individual legally empowered in the state where the consent is obtained) cannot provide consent, randomization and entry into the study could not proceed

CT Scan Exclusion Criteria:

  • High density lesion consistent with hemorrhage of any degree
  • Significant mass effect with midline shift
  • Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan. Sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00243906

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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Joseph P. Broderick, MD University of Cincinnati
Principal Investigator: Thomas A. Tomsick, MD University of Cincinnati
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Responsible Party: University of Cincinnati Identifier: NCT00243906    
Other Study ID Numbers: R01NS039160 ( U.S. NIH Grant/Contract )
First Posted: October 25, 2005    Key Record Dates
Last Update Posted: July 25, 2012
Last Verified: July 2012
Keywords provided by University of Cincinnati:
acute ischemic stroke
recombinant tissue plasminogen activator
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action