StrokePhase 2NCT00243906
Interventional Management of Stroke (IMS) II Study
A Phase 2 study testing Recombinant tissue plasminogen activator and Low-intensity ultrasound in people with Stroke, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Recombinant tissue plasminogen activator and Low-intensity ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Recombinant tissue plasminogen activator, Low-intensity ultrasound
- Keywords
- acute ischemic stroke, stroke, rt-PA, thrombolytic, recombinant tissue plasminogen activator
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant tissue plasminogen activatorDrug
Low-dose IV rt-PA (0.6 mg/kg) followed by delivery of additional IA rt-PA (up to 22 mg).
Low-intensity ultrasoundProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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,
Measured: 60 minutes after start of IA therapy
Primary Outcome Measure
modified Rankin Score of 0 or 1
Measured: 3 months following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2005 (estimated)
- Study startJan 2003
- Primary completionMay 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph P. Broderick, MD, Principal investigator, University of CincinnatiThomas A. Tomsick, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243906
- Sponsor's protocol ID
- R01NS039160
- Status last verified
- Jul 2012
- First submitted
- 24 Oct 2005
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17525387
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Management of Stroke (IMS) II Study
- ClinicalTrials.gov ID
- NCT00243906
- Acronym / sponsor ID
- R01NS039160
- Conditions
- Stroke
- Keywords
- acute ischemic stroke, stroke, rt-PA, thrombolytic, recombinant tissue plasminogen activator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jan 2003
- Primary completion
- May 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 25 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant tissue plasminogen activatorLow-dose IV rt-PA (0.6 mg/kg) followed by delivery of additional IA rt-PA (up to 22 mg). | Drug | – |
| Low-intensity ultrasoundDelivery 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. | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
- Background: PubMed 17525387IMS 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.
Related trials for Stroke
Not yet recruiting
Short-Term External Trigeminal Nerve Stimulation for Acute Ischemic Stroke: A Sham-Controlled Trial
Acute Ischemic Stroke
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Active, not recruitingPhase 3
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Intracranial Arteriosclerosis, Stroke
Recruiting
Real-time Personalized Brain State-dependent TMS After Stroke
Stroke
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph P. Broderick, MD principal investigator
University of Cincinnati
Thomas A. Tomsick, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant tissue plasminogen activator and Low-intensity ultrasound in people with Stroke, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 36 hours after completion of rt-PA infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00243906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2012; AzTrials last refreshed its copy on 3 Nov 2026.