Interventional Management of Stroke (IMS) II Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00243906
First received: October 24, 2005
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Stroke
Drug: Recombinant tissue plasminogen activator
Procedure: Low-intensity ultrasound
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interventional Management of Stroke (IMS) II Study

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Primary Safety Endpoint [ Time Frame: 36 hours after completion of rt-PA infusion ] [ Designated as safety issue: Yes ]
    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.

  • Primary Angiographic Outcome [ Time Frame: 60 minutes after start of IA therapy ] [ Designated as safety issue: No ]
    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,

  • Primary Outcome Measure [ Time Frame: 3 months following treatment ] [ Designated as safety issue: No ]
    modified Rankin Score of 0 or 1


Enrollment: 81
Study Start Date: January 2003
Study Completion Date: May 2007
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243906

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Joseph P. Broderick, MD University of Cincinnati
Principal Investigator: Thomas A. Tomsick, MD University of Cincinnati
  More Information

Publications:
Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00243906     History of Changes
Other Study ID Numbers: R01NS39160
Study First Received: October 24, 2005
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by University of Cincinnati:
acute ischemic stroke
stroke
rt-PA
thrombolytic
recombinant tissue plasminogen activator

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on April 17, 2014