Stroke-Related Clinical Research Studies

Current Clinical Research Studies

Carotid Revascularization Endarterectomy vs. Stent Trial (CREST)
Principal Investigators:Richard L. McCann, MD; Tony P. Smith, MD;Larry B. Goldstein, MD
CREST is an NIH-supported, prospective, randomized study to evaluate the safety and efficacy of carotid angioplasty and stenting vs. carotid endarterectomy in patients with symptomatic extracranial carotid artery stenosis. CREST has completed enrollment and is currently in the follow-up phase.

Randomized Evaluation of Recurrent Stroke comparing PFO Closure to Established Current Standard Treatment (RESPECT)
Principal Investigator: Larry B. Goldstein, MD
This is a multicenter randomized trial with comparing device closure of patent foramen ovale (PFO) with medical therapy in persons who have this condition and who have had an ischemic stroke within the previous 270 days of otherwise unknown cause.

The Evaluation of Patient with Acute Hypertension and Intracerebral Hemorrhage with Intravenous Clevedipine Treatment (ACCELERATE)
Principal Investigator: Carmelo Graffagnino, MD
The purpose of this study is to evaluate the efficacy and safety of an intravenous infusion of clevedipine for the treatment of acute hypertension in patients with intracerebral hemorrhage.

Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH)
Principal Investigator: Michael L. James, MD, FAHA
This discovery phase, multi-center case-control study will improve our understanding of the epidemiology of Intracerebral hemorrhage among minorities including the relative importance of potential candidate genes.  

High-Dose Deferoxamine in Intracerebral Hemorrhage (HI-DEF)
Principal Investigator: Michael L. James, MD, FAHA
The main purpose of this study is to determine whether treatment with deferoxamine mesylate is of sufficient promise to improve outcome before pursuing a larger clinical trial to examine its effectiveness as a treatment for brain hemorrhage. 

Novel Non-Invasive Optical Tomography in Hemispheric Stroke (CEPH)
Principal Investigator:Michael L. James, MD, FAHA
The purpose of this study is to test the feasibility and safety of a multi-channel optical oximetry device for measuring cerebral oxygenation.

Proteomic-Genomic Influences in Intracerebral Hemorrhage (PICH)
Principal Investigator: Michael L. James, MD, FAHA
The purpose of this study is to define differential genetic and proteomic expression and their associations with early pathophysiology, radiographic changes, and outcome after acute intracerebral hemorrhage.

Brain Injury Repository 
Principal Investigator: Michael L. James, MD, FAHA
The purpose of this study is to collect and store human samples (blood, CSF, and brain) after acute CNS injury.

TMS Augmented Post-Stroke Recovery (NICHE)-Upcoming
Principal Investigator: Larry B. Goldstein, MD
The purpose of this study is to evaluate transcranial stimulation combined with rehabilitative therapy for improving hand movement after stroke.

 

Recently Completed Stroke-Related Clinical Research Studies

Prevention Regimen For Effectively Avoiding Secondary Strokes (PRoFESS)
Principal Investigator: Larry B. Goldstein, MD
This was a multicenter randomized trial comparing clopidogrel (plavix) vs. aspirin plus delayed release dipyridamole (aggrenox) and telmesartan vs. placebo for prevention of recurrent ischemic stroke. Results were presented at the 2008 European Stroke Conference.

Duke-American Stroke Association Bugher Foundation Center for Stroke Prevention Research
Principal Investigator: Larry B. Goldstein, MD
Center-sponsored clinical research activities include studies aimed at determining genetic factors affecting the risk and consequences of small-vessel-type intracranial vascular disease.

Amphetamine-Enhanced Stroke Recovery
Principal Investigator: Larry B. Goldstein, MD
This is an NIH-supported, prospective, randomized pilot study aimed at studying the potential benefit of treatment with amphetamine combined with physical therapy in enhancing poststroke recovery in patients with ischemic stroke who have a motor deficit (difficulty walking and/or using an arm) and who can begin treatment between 10 and 30 days after stroke. No subjects are currently being enrolled.

Stenting vs Aggressive Medical Management for the Prevention of Recurrent Stroke (SAMMPRIS)
Principal Investigator: Carmelo Graffagnino, MD
This is a multicenter, NIH-supported, randomized, controlled study comparing stenting vs. medical management in patients with a narrowing of an intracranial artery who have had related symptoms.

Albumin in Acute Stroke Study (ALIAS)
Principal Investigator: Daniel T. Laskowitz, MD, MHS
This is an NIH-supported, Phase III, randomized, multicenter clinical trial. The primary objective is to determine whether the administration of human albumin increases the proportion of patients with acute ischemic stroke having favorable outcomes as compared to placebo after three months from randomization.

Clot Lysis Evaluating Accelerated Resoultion of Intraventricular Hemorrhage (CLEAR IVH)
Principal Investigator: Michael L. James, MD, FAHA
The study evaluates the effects of tissue plasminogen activator in patients who have had a brain hemorrhage involving the ventricles.

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