Clinical Stroke Research
Stroke research is a vital component for patients at the University of Florida's Stroke Program. Director Michael F. Waters, MD, PhD and the Stroke Program's staff are currently involved in National Institutes of Health (NIH)-funded clinical trials related to stroke prevention, acute stroke therapy and neuroimaging in stroke.
Because of their active participation in these and other clinical stroke research trials, Dr. Waters and his staff remain up to the minute in knowledge of new stroke therapies and can discuss the best treatment options for stroke patients.
In turn, their patients benefit by having the latest information on stroke prevention and treatment and, as appropriate, can participate in clinical research.
Current Clinical Trials
The Stroke Program at the University of Florida is currently participating in several clinical trials. The following links are to outside sources that contain information about some of the therapies that the program is investigating.
- Insulin Resistance Intervention after Stroke Trial (IRIS)(http://www.iristrial.org/)
Purpose: To determine the efficacy of pioglitazone in preventing recurrent stroke or heart attack among non-diabetic patients who have had a recent ischemic stroke or TIA.
Inclusion Criteria: Eligible patients not taking diabetic medication, with a stroke or TIA within 180 days and insulin resistant by lab testing.
Exclusion Criteria: Stroke/TIA caused by trauma or carotid dissection, life-limiting cancer, severe heart disease, severe liver disease, severe neurologic or psychiatric disease, use of oral contraceptives or oral steroids, pregnancy, life expectancy < 5 years, glycated hemoglobin level greater than 7. - Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS)
(http://clinicaltrials.gov/ct2/show/NCT00576693?term=sammpris&rank=1)
Purpose: To compare the safety and effectiveness of either Intensive Medical Therapy PLUS Stenting or Intensive Medical Therapy ONLY in preventing stroke, heart attacks or death.
Inclusion Criteria: TIA or stroke within 30 days of enrollment attributed to 70-99% stenosis of a major intracranial artery; Modified Rankin score of 3; target area of stenosis in an intracranial artery that has a normal diameter of 2.00 mm to 4.50 mm; target area of stenosis is =14 mm; negative pregnancy test; patient is available by phone.
Exclusion Criteria: TIA or stroke that is attributed to < 70% stenosis of a major intracranial artery; other extracranial or intracranial stenosis (70%-99%) or occlusion; bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which artery is symptomatic; stenting, angioplasty, or endarterectomy of an extracranial or intracranial artery within 30 days; previous treatment of target lesion with a stent, angioplasty, etc, or plan to perform angioplasty/stenting of target lesion; plan to perform angioplasty or stenting of an extracranial tandem vessel; isolated stenosis of the ACA, PCA, MCA division, a distal branch of the MCA, PICA, AICA, SCA; presence of intraluminal thrombus proximal to or at the target lesion; any aneurysm near target artery; intracranial tumor (except meningioma) or any intracranial vascular malformation; CT or other evidence of severe calcification at target lesion; thrombolytic therapy within 24 hours prior to enrollment. - MR and Recanalization of Stroke Clots Using Embolectomy
(MR RESCUE)
Purpose: To determine if diffusion-perfusion MRI can indentify patients who might benefit from mechanical embolectomy with a balloon catheter and retriever (MERCI).
Inclusion Criteria: New focal disabling neurologic deficit consistent with acute cerebral ischemia (NIHSS >/= 6); clot retrieval procedure can be initiated within 8 hours from onset; large vessel proximal anterior circulation occlusion on MR angiography (internal carotid, M1 or M2 MCA); pretreatment MRI performed according to MR RESCUE protocol; premorbid modified Rankin score of 0-1; signed informed consent; age 18-85 (including endpoints); allowed but not required--patients treated with IVtPA (with persistent target occlusion on post-treatment MR RESCUE MRI protocol)
Exclusion Criteria: NIHSS >/= 30; contraindication to MRI; acute intracranial hemorrhage; coma; rapidly improving neurological signs prior to randomization; pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations; pregnancy; renal failure; known allergy to iodine previously refractory to pretreatment medications; current participation in another experimental treatment protocol; Contrast-Enhanced Neck MRA suggests proximal ICA occlusion, proximal carotid stenosis > 67%, or dissection; INR > 3.0; PTT > 3 x Normal. - Penumbra Imaging Collaborative Study (PICS): A Multicenter Trial to Assess Outcome of Patients Revascularized by the Penumbra™ System
(PICS)
Purpose: The primary aim of this study are to gather data on the "real world" experience of the Penumbra System and to determine if there is a correlate between the imaging-defined size of the ischemic penumbra at admission and patient outcome in patients already treated by the System. This will be accomplished by the collection of all available admission imaging data along with patient clinical and functional outcome results at 90-day follow-up to determine if a positive association exists between these variables. A secondary aim is to collect and summarize the 90-day functional outcome data for the purpose of sample size estimation for a potential randomized concurrent controlled trial. This will be accomplished by collecting the data on 90-day modified Rankin Scores (mRS) and all cause mortality.
Inclusion Criteria: All patients who signed informed consent and are revascularized by the Penumbra™ System in accordance to the Instruction For Use are eligible for this study.
- Motor Function After Stroke
Purpose: To examine whether the Valmet66 BDNF polymorphism is related to recovery from stroke, particularly motor recovery, at 3 and 9 months post stroke.
Inclusion Criteria: 1) age 18-85; 2) history of ischemic stroke, radiologically verified as being supratentorial with onset 2-4 days prior to the time of the first study measurement; 3) Arm motor deficits that are neither mild nor devastating, defined as ARAT score 3-37 out of a normal 57; 4) able to attend all study sessions
Exclusion Criteria: 1) moderately-severely reduced alertness (NIH Stroke Scale question 1c must be 0); 2) severe aphasia (NIH Stroke Scale question 9 must score 0-1) or inability to speak English to an extend required for reasonable safe and compliant study participation; 3) reasonable likelihood of receiving standard post-stroke rehabilitation/therapy appropriate for clinical state; 4) another diagnosis having a major effect on arm/hand function; 5) pre-stroke arm/hand disability that was major in extent; 6) co-existent major neurological or psychiatric disease; 7) severe cardiopulmonary disease; 8) significant alcohol or drug abuse in the prior 3 years; 9) terminal medical diagnosis with likely < 6 months survival; 10) stroke deficits are judged unstable at time of baseline exam - Basal Ganglia and Cognitive Changes in Gulf War Illness and Stroke (Basal Ganglia Lesion)
(Gulf War Study)
Purpose: Many veterans of the 1991 Gulf war have experienced multi-symptom complaints including cognitive changes for which the basal ganglia and frontal lobes appear to be involved. To better understand these changes we need to compare functioning of these individuals to patients with compromise of the basal ganglia and frontal lobes. Therefore in addition to patients with Gulf War Illness, the current study involves patients who have suffered a left hemisphere stroke affecting the basal ganglia. Specifically we are interested in the involvement of the basal ganglia during complex verbal and related cognitive tasks. Using functional magnetic resonance imaging (fMRI) and various language and verbal measures, we will assess differences in complex verbal functions in both groups. In doing so, we hope to define the neuro-cognitive changes experienced by 1991 Gulf War Veterans and further our understanding of stroke related neuro-cognitive changes in the hopes of developing treatments or methods for managing symptoms of Gulf War Illness.
Inclusion Criteria: Left Ischemic Basal Ganglia Lesion verified by CT/MRI scan taken at least one day post-stroke; 6 months post stroke onset ; Right Handed; English as primary language; Obtained a High School Diploma; Lesion territories to include: More than half of left basal ganglia, Some extension into the thalamus and insula is acceptable, No other cortical lesions
Exclusion Criteria: More than minimal Aphasia; *Dementia; History of neurological conditions not relevant to the study: Severe traumatic brain injury, epilepsy, learning disability, etc.; Drug or alcohol abuse within past 6 months; *Diagnosis of Post Traumatic Stress Disorder (PTSD); *Major Affective Disorder; Severe Hearing Loss; Contra-indication for MRI scanning (e.g. pacemaker, ferromagnetic implants, other ferromagnetic materials in the body, claustrophobia)
[* If in doubt refer to study; we screen all patients on these variables.] - Infarct Modeling through Perfusion Assessment by CT
(IMPACT)
Purpose: The purpose of this work is to develop an accurate way to make this prediction using CT scanning, a technology that is widely available in hospitals throughout the country.
Inclusion Criteria: Acute symptomatic supratentorial infarct; CTP performed at admission (within 9 hours of symptom onset)
Exclusion Criteria: Creatinine > 1.5; pre-existing chronic renal disease; history of allergic reaction or other contraindication to contrast dye; clinical signs of congestive heart failure on examination or CXR; positive pregnancy test (pre-menopausal women only); unstable angina, enzyme or EKG evidence of cardiac ischemia*; subject has proven alternate etiology for stroke-like symptom (e.g. ICH, SAH, subdural hematoma, meningitis, seizure, multiple sclerosis, tumor); acute symptomatic infratentorial ischemia.
* applies only to those patients who would receive a CTA/CTP for study-specific research purposes - Effect of Statin on Atherosclerosis and Vascular Remodeling Assessed with Intravascular Sonography
(SARIS)
Purpose: The primary objective of the study is to collect preliminary safety data and to gain experience in the USA with the use of a bare-metal self-expanding stent (Wingspan™, manufactured by Boston Scientific Corporation) to restore vessel diameter lumen following acute symptomatic intracranial arterial occlusion.
Inclusion Criteria: Male or female patients with symptomatic iliac arterial disease eligible for PTA and/or stent-placement in the common iliac artery; Serum total cholesterol 5–8 mmol/ l; Serum LDL >3 mmol/ l; and written informed consent
Exclusion Criteria: Endocrine disorders (Diabetes Mellitus); Use of lipid-lowering drugs within the last year; Uncontrolled hypertension (DBP >110 mmHg, SBP >180 mmHg); Use of drugs known to be associated with rhabdomyolysis when used in conjunction with statins (e.g. cyclosporin, erythromycin, azole anti-fungal drugs and niacin); History of serious adverse drug reactions, hypersensitivity or allergy to statins; Significant active liver disease (>3x upper limit of normal); Renal insufficiency (serum creatinine >160 mol/ l) or micro-albumin in urine; Concurrent therapy with long-term immunosuppressants; History of alcoholism, drug abuse or other emotional or intellectual problems likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements
Clinical Trials National Directory
Stroke Clinical Trials Directory (http://www.strokecenter.org/trials/)
