Interventional Management of Stroke (IMS) II Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University of Cincinnati
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Primary Safety Endpoint
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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.
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,
Primary Outcome Measure
Time Frame: 3 months following treatment
modified Rankin Score of 0 or 1