Stroke and Cerebrovascular Disease Trials
Acute Stroke Clinical Trials
Participants are enrolled early on in their hospitalization for stroke.
| TRIAL NAME Sponsor Website | Study Protocol | PI | Contact |
|---|---|---|---|
| MR-OMI Magnetic Resonance-Oxygen Metabolic Index |
Purpose: To evaluate Acute Stroke Patients with a new MRI sequence which measures oxygen metabolism Protocol: Both tPA-treated and untreated patients will undergo four MRI scans: 1) immediately after arrival, 2) at 6 hrs after stroke onset, 3) at 24 hrs after stroke onset, and 4) at one month after stroke onset. Risks: Participant may become anxious if he/she has claustrophobia. Benefits: Study team may gain information about size, location, and severity of the stroke from the MRI's. Payment: Participants will receive $100 to compensate for travelling and time spent to return for 1 month scan. |
Jin-Moo Lee, MD, PhD | Laura Carpenter (314) 747-5552 |
| IMS-3 Interventional Management of Stroke - Phase 3 Trial |
Purpose: To compare standard intravenous (IV) tPA to 2/3 dose IV tPA + 1/3 Intra-arterial (IA) tPA +/- mechanical intervention to remove clot in acute ischemic stroke; must be eligible for standard IV tPA and have NIH Stroke Scale ≥10 Protocol: Patients will be consented and then randomized to one of two groups. Group I will receive the standard dose of IV tPA. Group II will receive the standard dose of IV tPA for 40 minutes and then undergo cerebral angiography where the patient will receive IA tPA with possible intervention with a device, including the EKOS Micro-Infusion (NeuroWave Infusion) System, Concentric Merci® Retriever, or The Penumbra SystemTM Risks: risk of angiogram (hematoma, dye reaction); hemorrhage from tPA; risk of device; possible risk of sedation Benefits: No direct benefit; Indirect benefit is potentially improved outcome with one of the interventions |
Peter Panagos, MD | Jill Newgent, RN (314) 747-3795 |
| EXTEND Extending the Therapeutic Window for Brainstem and Cerebellar Stroke |
Purpose: To use MRI to examine patients with brainstem or cerebellar strokes who present from 4.5 to 12 hours after stroke onset Protocol: Patients will be evaluated in the ED according to several inclusion and exclusion criteria. The patient will then be scheduled for an MRI during the first 12 hours from stroke onset. Risks: Participant may become anxious if he/she has claustrophobia. Benefits: Participants will have a free MRI scan that may be used by their neurology team to help in their management. |
Colin Derdeyn, MD | Jill Newgent, RN (314) 747-3795 |
| MR-WITNESS A Phase IIa Safety Study of Intravenous Thrombolysis with Alteplase in MRI-Selected Patients http://www.strokecenter.org/trials/TrialDetail.aspx?tid=1069 |
Purpose: Trial of IV tPA in patients with unwitnessed stroke onset, last known well <24 hours, and MRI evidence of early stroke. Protocol: tPA infusion must be started in eligible patients within 4.5 hours from time of symptom discovery. Risks: Risk of tPA (hemorrhage). Risk of MRI (claustrophobia) Benefits: Indirect benefit from MRI information about size, location and severity of stroke. Possible benefit of tPA. |
Andria Ford, MD | Jannie Serna, RN (314) 362-3859 |
| STOP-IT The Spot Sign for Predicting and Treating Intracerebral Hemorrhage Growth Trial |
Purpose: Factor VII vs. Placebo for intracerebral hemorrhage with "Spot Sign" on CTA within 5 hrs of symptom onset Protocol: Participants will undergo a CT angiography (CTA) to detect a "spot sign". If present, participants will be randomized to recombinant activated factor VII or placebo. Participants will have follow-up phone calls at one and three months. If the Spot Sign is not present, participants will receive standard of care. Risks: Prothrombotic event: leg clot, heart attack, pulmonary embolus, Ischemic stroke Benefits: Possible Benefit of Factor VII to reduce ICH growth |
Peter Panagos, MD | Laura Carpenter (314) 747-5552 |
| A Phase 2 Multicenter, Randomized, Double-Blind, Placebo Controlled Study Of The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke |
Purpose: To evaluate safety and tolerability of multiple dose administration of PF-03049423 on participants with Ischemic Stroke. Protocol: A phase II, multicenter, randomized, double blind, placebo controlled study. Ischemic stroke patients, 18-85 years of age, start study agent within 72 hours of symptom onset, and continue once daily dose for 90 days. Risks: Muscle pain, muscle spasms, and headache were the most frequently reported events in previous trials. Other unknown risks. Benefits: Possible improvement in recovery after ischemic stroke. Participants receive study medication at no cost and $50 for travel for follow up visits. |
Jin-Moo Lee, MD, PhD | Jannie Serna, RN (314) 362-3859 |
| NEST NeuroThera® Efficacy and Safety Trial - 3 (NEST-3) |
Purpose: A double-blind, randomized, placebo-controlled, multicenter, study to assess the safety and efficacy of transcranial laser therapy with the NeuroThera® Laser System (NTS) for treatment of acute ischemic stroke within 24 hours of stroke onset Protocol: Screening Visit (1-1.5hr): You and the doctors will decide if treatment with the NTS is an option for you. Baseline Visit (up to 2hr): If you qualify, you will receive the transcranial laser therapy procedure. Follow-Up Visits: The Follow-up period is about three months. Risks: Amnesia, scalp redness, cut, pain, reaction, warmth, itching; slow heart rate; Abnormal hair growth; Headache; minor bleeding into stroke; Insomnia; Nausea, Vomiting; Neck Pain; Rash; Skin Laceration or nicks on the scalp from hair removal; other unknown risks. Benefits: NTS may improve the outcome from your stroke or may not. Payment: Patients will receive $50/visit for a possible total of $300 for 6 completed study visits. |
Colin Derdeyn, MD | Julie Naylor (314) 747-8794 |
| STICH-II Surgical Trial in Lobar Intracerebral Hemorrhage |
Purpose: To establish whether a policy of earlier surgical evacuation of a hematoma in selected patients with spontaneous lobar ICH will improve outcome compared to a policy of initial conservative treatment. Protocol: Worldwide study with randomization within 48 hours of ICH ictus in eligible patients to either surgical removal of the hematoma or medical management. CT at 3-5 days post randomization. 6mo mailed questionnaire follow-up. Risks: Both surgery and medical management are considered standard of care in this patient population. Minimal radiation exposure due to CT scan. Benefits: To better understand if surgical removal of hematoma in select ICH patients (bleed within 1cm of cortex surface, volume of hematoma 10-100ml, and not neurologically devastated) may have some benefit over medical management. |
Greg Zipfel, MD | Abbie Bradley & Kristin Kraus (314) 747-8882 |
|
IPSS No current financial support; start-up supported by Child Neurology Society/Child Neurology Foundation MultiCenter Clinical Research Grant |
Purpose: To establish an observational database for infants and children with stroke for current and future research. Protocol: Collect clinical data from acute stroke and recovery questionnaires at subsequent follow-up visits. Risks: Minimal Benefits: Contribute to knowledge of types of stroke, potential risk factors for stroke, and basic recovery information from stroke in pediatric population |
Kristin Guilliams, MD | Kristin Guilliams, MD (314) 454-6120 |
|
SIPS Pediatric Epilepsy Research Foundation |
Purpose: Understand incidence of seizures in first year after pediatric ischemic stroke Protocol: In addition to IPSS clinical data collection, parents will be given seizure diary to record any possible seizure activity. Seizure and clinical follow-up occurs at 3 months and 12 months Risks: Minimal Benefits: Contribute to knowledge of of potential long term complications of pediatric stroke |
Kristin Guilliams, MD | Kristin Guilliams, MD (314) 454-6120 |
Chronic Stroke Clinical Trials
Participants are enrolled during or after their hospitalization for stroke.
| Trial Name | Purpose of Study | PI | Contact |
|---|---|---|---|
| RESPECT Respect-Randomized Evaluation of Recurrent Stroke comparing Patent Foramen Ovale Closure to Established Current Standard of Care Treatment |
Purpose: The objective of this study is to investigate whether patent foramen ovale (PFO) closure is superior to current standard of care medical treatment in the prevention of cryptogenic stroke (stroke of unknown cause). Protocol: Once the subject has completed the baseline examination and has been found to meet all Inclusion and Exclusion Criteria, patients will be randomized to medical standard of care vs. PFO closure with the device. Patients must be enrolled within 9 months of stroke onset. Risks: The risks of percutaneous PFO closure consist of the risk of the implantation procedure and the long-term risk of the device itself. The implantation risks include, but are not limited to, arrhythmias, vascular or cardiac perforation, and air embolus. Benefits: There may or may not be benefit to PFO closure to prevent strokes. |
Jin-Moo Lee, MD, PhD | Jill Newgent, RN (314) 747-3795 |
| CRYSTAL-AF Cryptogenic Stroke and Underlying Atrial Fibrillation http://www.strokecenter.org/ |
Purpose: To compare the Reveal® XT Insertable Cardiac Monitor to standard of care medical treatment for detection of atrial fibrillation in patients with cryptogenic stroke (stroke of unknown cause). Protocol: Patients who give informed consent will be assigned randomly to one of two groups: Reveal device or medical therapy. Risks: The Reveal device has been approved for use by the U.S. Food and Drug Administration (FDA). Potential risks include: mild bruising or infection at the implant site or rejection of the Reveal device. Benefits: If you receive the Reveal device, it is possible that the increased cardiac monitoring could result in improved diagnosis and management of atrial fibrillation if present. |
Andria Ford, MD | Jill Newgent, RN (314) 747-3795 |
| IRIS Insulin Resistance Intervention after Stroke Trial |
Purpose: To test the effectiveness of pioglitazone vs. placebo in preventing future strokes and heart attacks among non-diabetic, insulin-resistant persons who have had a recent stroke or TIA. Protocol: Participants who screen positively for insulin resistance are randomized to pioglitazone or placebo, followed by a 2 month titration of study medication. Participants then remain on a steady dose of study medication and are followed by telephone every 2 weeks for 3 months and then every 4 months. Laboratory testing is conducted at 12 months and then yearly. The duration of this clinical trial is 5 years. Risks: Participants may experience a decrease in hemoglobin, lower extremity edema, muscle ache, headache, or shortness of breath. Benefits: Pioglitazone may be effective in treating insulin resistance and preventing future heart attacks and strokes. |
Jin-Moo Lee, MD, PhD | Laura Carpenter (314) 747-5552 |
| VERITAS Vertebrobasilar Flow Evaluation and Risk of Transient Ischemic Attack and Stroke |
Purpose: The purpose of this research study is to determine if patients with vertebrobasilar disease who have had a stroke or TIA are at higher risk of repeated stroke if the MRI shows that the blood flow to the back of the brain is significantly reduced on the MRI test. Protocol: MRI test will be performed at enrollment, 6 months, 12 months, and 24 months. Also, participants will receive monthly assessment phone follow-up for first 12 months and an 18 month follow -up visit with the Neurosurgeon. Risks: Discomfort related to an IV placed for the MRI test. Possible infection at the site of the IV placement. Anxiety if participant is claustrophobic. Unlikely allergic reaction to the MRI contrast dye. Benefits: The monthly phone calls are used to assess whether the participant may have had another TIA/Stroke which may allow for early evaluation of a recurrent stroke. Future benefit for stroke patients after establishing which imaging studies better predict the risk of recurrent strokes so that they may be prevented or treated more aggressively. |
Greg Zipfel, MD | Abbie Bradley & Kristin Kraus (314) 747-8882 |
| REGENESIS Recovery Genetics after Ischemic Stroke |
Purpose: To examine associations between rare variants in candidate genes involved in brain remodeling and recovery after ischemic stroke. Protocol: Patients will be evaluated at 24 hours and 3 months after ischemic stroke to assess recovery. Blood will be collected for genomic analysis. Risks: Discomfort at the puncture site. Benefits: No direct benefit by participating in this study. Payment: Participants will receive $100 for time and travel to complete the 3 month follow up visit. |
Jin-Moo Lee, MD, PhD | Julie Naylor (314) 747-8794 |
| PET-PIB PET study to assess post-stroke dementia |
Purpose: to ascertain if pre-clinical Alzheimer's Disease predicts post-stroke dementia Protocol: Baseline cognitive history assessment, psychometrics, MRI, and PET/PIB (amyloid tracer) scan; quarterly phone visits; annual MRI, clinical cognitive/memory testing, and psychometric testing to assess post-stroke dementia Risks: Participant may become anxious if he/she has claustrophobia; pacemaker excludes participant. Benefits: MRI post-stroke, annual clinical assessment of cognition and memory and MRI Payment: $175 at baseline; $250 annually if MRI, Psychometrics, and Clinical Visit completed |
John C. Morris, MD | Peggy Kelly RN (314) 362-1558 |
| Understanding the effects of stroke using functional connectivity MRI | Purpose: To learn more about how the brain recovers from stroke using functional MRI. Protocol: 3 study visits (2 weeks after stroke, 3 months and one year post-stroke). Each visit includes testing of strength, speech, memory, vision and attention (1-2 hours) and a brain MRI (1-1.5 hours) Risks: Fatigue, frustration, anxiety if claustrophobia in MRI. Benefits: Study findings may improve medical care for future stroke patients. Payment: Participants will be paid for their time. |
Mauricio Corbetta, MD | Kristi Zinn (314) 362-3988 |
