Clinical Trials

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Induced Hypertension for Acute Ischemic Stroke

Insulin Resistance in Ischemic Stroke (IRIS) Trial

PFO Closure Trial

Prevention Regimen for Effectively avoiding Second Strokes

Pilot Clinical Trial of Induced Hypertension for Acute Ischemic Stroke

Principal Investigator:  Robert Wityk, M.D.

This pilot study is funded by the National Institutes of Health and uses a standard protocol of blood pressure elevation for patients with acute ischemic stroke who can be treated within 12 hours of onset of symptoms. Intensive monitoring in the Neuro Critical Care Unit and assessment of blood flow to the brain by MRI are important components of this study. Follow-up includes MRI at one month and neurologic and language testing at one and three months.

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Insulin Resistance in Ischemic Stroke (IRIS) Trial

Principal Investigator—Robert Wityk, MD, 410.955.2228
Study Coordinator------Susan Rice, RN, MPH 410.614.3460

This is a phase III clinical trial sponsored by the National Institutes of Health and coordinated by Yale University School of Medicine investigating the use of pioglitazone (Actos) in patients with ischemic stroke who are found to have insulin resistance. Insulin resistance is a central component of the “metabolic syndrome” and this study is one of the first to investigate treatment of this condition with an insulin-sensitizing agent. Patients are randomized to pioglitazone or placebo and are followed for an average of 2 to 3 years. Prior to study enrollment, patients undergo testing for insulin resistance.

INCLUSION CRITERIA
• Ages 45 years or greater at the time of randomization.
• Non-cardioembolic ischemic stroke no less than 14 days and no more than six months before randomization.
• Documentation of insulin resistance as defined by a value over 3.0 on the Homeostasis Model Assessment of insulin sensitivity
• Fasting glucose <126 mg/dl

EXCLUSION CRITERIA
.• Severely disabling stroke as indicated by a Rankin Grade above 3
• Persons whose ischemic stroke was related to significant head trauma, carotid dissection, embolism from an artificial heart valve or medical instrumentation
• Prior diagnosis of diabetes mellitus
• HgbA1c >7.0 percent
• Irreversible medical conditions likely to affect short-term survival
• Severe neurologic or psychiatric disease

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PFO Closure Trial

Principal Investigator: Eric Aldrich, MD, 410.614.9604

Study Coordinator: Tracey Hartmann, LPN, CCRP 410.502.5217

The CLOSURE I Study is a randomized trial comparing transcatheter PFO closure with the STARFlex® Septal Occluder to best medical therapy in selected stroke and TIA patients. To be eligible, you must have had a stroke or definite clinical TIA within six months of enrollment without other identifiable cause.

Major Inclusion Criteria
• Age 18 – 75 years inclusive
• Positive contrast valsalva bubble study by TEE for Patent Foramen Ovale (PFO), with or without atrial septal aneurysm

• Be able to comply with follow up over two years
• Be competent to, or have a legal guardian competent to provide informed consent following full disclosure of risks and benefits of both treatment arms by a study investigator
• Venous access capable of accepting a 10F minimum vascular sheath
• Have, or be willing to, discontinue hormonal based contraceptive use prior to enrollment and for the term of the study
• Has cardiac anatomy based on enrollment echo that will allow for placement of the implant if randomized to the implant arm

Major Exclusion Criteria
• Carotid artery stenosis > 50 percent
• Intracranial stenosis >50 percent appropriate to symptoms
• Complex aortic arch artheroma with high risk features for embolism
• Aortic arch, carotid or vertebral artery dissection
• Mitral or Aortic valve stenosis, vegetation, or calcification >5mm MAC thickness
• Active pregnancy
• Active infections (contact study coordinator).
• Active infective endocarditis or bacteremia
• Prosethetic heart valves in any location
• Anterior MI within 3 Months of neuro event
• Chronic Atrial fibrillation (see protocol)
• Thrombus in , or occluded, venous access route
• Contraindication to heparin, aspirin, clopidogrel, or coumadin, or a known medical condition that requires continuous coumadin
• Most coagulopathies (contact study coordinator)
• Patient enrolled in another investigation study where clinical endpoint interference may occur
• Permanent pacemaker or IVC filter
• Serum creatinine >2.0 mg/dL
• Patients with known vasculitis or neurologic disorder

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Prevention Regimen for Effectively avoiding Second Strokes
ProFess Trial
Principal Investigator---Daniel Hanley, M.D. 410.614.6996
Study Coordinator----Susan Rice, RN, MPH 410.614.3460

The objective of the trial is to compare the efficacy and safety of Aggrenox to clopidogrel and to compare Micardis to placebo in prevention of recurrent stroke. The trial is a double-blind active and placebo controlled international study, enrolling 18,500 patients worldwide.

INCLUSION CRITERIA
• Patients at least 50 years old and who have had an ischemic stroke within 120 days of entry. Patients 50-54 year and/or 90-120 days after the qualifying stroke provided the patient has at least two additional risk factors -- diabetes mellitus, hypertension, smoker, obesity, previous vascular disease, end-organ damage. Stroke diagnosis is based on clinical judgement of the investigator with evidence on CT or MRI of the brain.
• Patient’s neurological and clinical condition must have stabilized

EXCLUSION CRITERIA
• Patients unable to give informed consent
• Patients presenting with a hemorrhagic stroke
• Patients unable to take study medications by mouth-no crushing medications
• Pre-stroke Rankin>4, stroke caused by surgical or cardiovascular procedure
• Patients currently treated by an ARB who are unable or unwilling to discontinue treatment with this medication
• Known severe coronary artery disease, including unstable angina or MI within three months

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