Interventional Management of Stroke (IMS) II Study

NCT00243906 | Completed Phase 2 DMC

• 1 other identifier: R01NS039160
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

acute ischemic stroke; stroke; rt-PA; thrombolytic; recombinant tissue plasminogen activator

Outcome Measures

Primary Outcomes (3)

• Primary Safety Endpoint

  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.

  36 hours after completion of rt-PA infusion

• Primary Angiographic Outcome

  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,

  60 minutes after start of IA therapy

• Primary Outcome Measure

  modified Rankin Score of 0 or 1

  3 months following treatment

Interventions

Recombinant tissue plasminogen activator DRUG

Low-dose IV rt-PA (0.6 mg/kg) followed by delivery of additional IA rt-PA (up to 22 mg).

Low-intensity ultrasound PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (1)

• IMS II Trial Investigators. The Interventional Management of Stroke (IMS) II Study. Stroke. 2007 Jul;38(7):2127-35. doi: 10.1161/STROKEAHA.107.483131. Epub 2007 May 24.

  PMID: 17525387 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Tissue Plasminogen Activator; Ultrasonic Waves

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Joseph P. Broderick, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

• Thomas A. Tomsick, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 24, 2005
• First Posted: October 25, 2005
• Study Start: January 1, 2003
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2007
• Last Updated: July 25, 2012

Record last verified: 2012-07

Locations

US (1)