Ongoing Research Trials

NAVIGATE ESUS is a descriptor for the world wide clinical trial Multicenter, a randomized, double-blind, double-dummy, active competitor, event-driven, superiority phase Ill study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent embolic stroke of undetermined source (ESUS). The clinical trial, funded by Bayer Pharmaceuticals, has ended recruitment on September 20, 2017. The study enrolled a total of i7214 in all their global sites. In the US, the study enrolled 187 patients and TTUHSC El Paso's Department of Neurology was able to recruit a total of 6 patients.

The pharmaceutical trial was established in response to the clinical need to find more effective anti-thrombotic medications. Patients enrolled into this study were randomized into either a blind ASA group or a blind Rivaroxaban group. The purpose is to develop an oral anticoagulant with a low-risk profile for ESUS patients. The study continues as follow-up for all subjects enrolled. Un­ blinding of the groups and research outcomes are expected by the Sponsor on the 3rd or 4th quarter of 2018.

The primary investigator (Pl) is Alberto Maud, M.D., and co-investigators include Salvador Cruz­ Flores, M.D., Gustavo J. Rodriguez, M.D., and Paisith Piriyawat, M.D.

For more information regarding this clinical trial, please contact Clinical Research Coordinator, Israel Alba, MBA, CCRP, at lsrael.alba@ttuhsc.edu.

RESPECT ESUS is a descriptor for the world wide clinical trial Multicenter, Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the efficacy and safety of the oral Thrombin inhibitor dabigatran Etexilate (110 mg or 150 mg, oral b.i.d.) versus acetylsalicylic acid (100 mg oral q.d.) in patients with Embolic Stroke of Undetermined Source (RESPECT ESUS).

Approximately 20-25% of ischemic strokes are not lacunar (i.e. due to small artery disease), are not associated with occlusive atherosclerotic stenosis, and do not have a major cardio embolic source, such as in atrial fibrillation. Recent monitoring and imaging studies have characterized a number of potential sources of embolism in these patients, supporting that most strokes formerly called "cryptogenic" can be more usefully characterized as an Embolic Stroke of Undetermined Source (ESUS). Improvements in imaging technologies and a better understanding of the underlying pathophysiology of ESUS have resulted in a pragmatic clinical definition and an international "ESUS Working Group" has been established with this group defining ESUS as a new stroke entity. The embolic mechanism implies a common potential treatment strategy, anticoagulation, making precise characterization of the embolic source of uncertain clinical value. The purpose of this clinical trial is to test the effectiveness and safety parameters of dabigatran etexilate plus placebo versus aspirin and placebo in an ESUS randomized, double-blind clinical trial. Dabigatran etexilate is already FDA approved as a

blood-thinning medicine used to reduce the risk of stroke and blood clots in patients with atrial fibrillation not caused by a heart valve problem, as well as for the treatment of blood clots in patients with deep vein thrombosis or pulmonary embolism.

The clinical trial is funded by the pharmaceutical Boehringer lngelheim and is actively enrolling patients. The study is scheduled to finish global recruitment on December 31, 2017.

 

The primary investigator (Pl) is Paisith Piriyawat, M.D., and co-investigators include Alberto Maud, M.D., and Gustavo Jose Rodriguez, M.D.

For more information regarding this clinical trial, please contact Clinical Research Coordinator, Israel Alba, MBA, CCRP, at lsrael.alba@ttuhsc.edu.

Nearly 800,000 people in the United States have a stroke every year. Stroke is currently the 5th leading cause of death annually. Stroke is also the leading cause of long-term disability and the leading preventable cause of disability. An estimated 15% of all strokes are a result of untreated atrial fibrillation (AF), and those patients suffering from stroke and AF typically have larger infarct areas and poorer outcomes. Atrial fibrillation is the most common type of arrhythmia, affecting an estimated 2.7 million Americans, and the occurrence of Atrial Fibrillation increases the risk of stroke nearly five times over the risk in the general population. Preventing recurrent stroke in patients with atrial fibrillation is of the utmost importance. Long term anticoagulation is standard for secondary stroke prevention in patients with AF. Current AHA guidelines state that it is reasonable to initiate anticoagulation within 14 days, but do not currently offer recommendations on the optimal time of initiation.

The primary aims of the study is to determine the optimal time to initiate anticoagulation with a Non-Vitamin K Oral Anticoagulant (NOAC) after ischemic stroke in patients with non-valvular atrial fibrillation.

The study is actively recruiting patients at Tennet Hospitals of El Paso and at the University Medical Center of El Paso (UMC-EI Paso).

The study is funded through The University of Texas at Austin of the Lone Star Stroke Research Consortium of Texas.

The Primary invest igator (Pl) is Salvador Cruz-Flores, M.D., MPH, and co-investigator Jose Gustavo Rodriguez, M.D.

For more information regarding this clinical trial, please contact the Clinical Research Coordinator, Israel Alba, MBA, CCRP, at lsrael.alba@ttuhsc.edu

 

Inherited Peripheral Neuropathy (IPN) results in damage of the peripheral nerves and causes significant morbidity including pain, numbness, tingling, weakness, and walking difficulty.

IPN can be evaluated by nerve conduction study and electromyography. These electrodiagnostic tests have demonstrated several pathological processes including demyelination, axonal defects, and the presence of denervation. But while these diagnostic approaches have advanced our description of IPN, they have done little to allow understanding the underlying mechanism of the peripheral neuropathy. Inherited Peripheral neuropathy is an incurable disorder. Regardless of the underlying causative gene, the treatment is symptomatic. The study will isolated patient's DNA from buccal swab or saliva sample and be delivered to the University of Texas at El Paso for its analysis.

The primary objective of this study is to identify novel genes associated with inherited peripheral neuropathy.

The study is actively identifying potential patients consistent with genetic IPN at the Outpatient Clinic of the Department of Neurology, TTUHSC- El Paso.

The Primary Investigat or (Pl) is Darine Kassar, M.D.

For more information regarding this clinical trial, please contact the Clinical Research Coordinator, Israel Alba, MBA, CCRP, at lsrael.alba@ttuhsc.edu

It is a standardpractice in inpatient and intensive care settings to monitor blood pressure by Non-Invasive technique. Blood pressure measurements frequently guide management in these settings. Discrepancies between direct intra-arterial blood pressure (IABP) and indirect noninvasive blood pressure (NIBP) measurements can adversely affect therapeuticdecisions and may have a negative impact on outcomes. To date, there are no studies evaluating the accuracy or precision of these devices in acute ischemic stroke patients undergoing endovascular procedures. In addition, there are no large clinical studies evaluating NIBP monitoring in a complex medical intensive care population with varying hemodynamics. Our hypothesis is that NIBP in the medical intensive care patients is highly variable and not a reliable means of arterial blood pressure monitoring. There is limited data in critically ill patients

The primary objective of this study is to compare direct Intra-Arterial Blood Pressure (IABP) with Non-Invasive Blood Pressure (NIBP) readings among acute ischemic stroke patients undergoing endovascular procedures.

The study is actively searching for patients at the University Medical Center of El Paso. The study is funded by the Department of Neurology TTUHSC El Paso.

The Primary investigato r (Pl) is Jose Gustavo Rodriguez, M.D. and co-investigators are Salvador Cruz-Flores, M.D., MPH and Alberto Maud, M.D.,

For more information regarding this clinical trial, please contact the Clinical Research Coordinator, Israel Alba, MBA, CCRP, at lsrael.alba@ttuhsc.edu

 
 

Strokes & Transient lschemic Attack (TIA), or a cerebrovascularaccidents (CVA), are neurologic insults that occurs when either the blood supply to part of the brain is reduced or is lacking or when blood vessels bursts in the brain. In the United States, it is the leading cause of chronic debilitating morbidity and the fifth most common cause of mortality. Thus, continuing to expand our knowledge in understanding the epidemiology, its pathophysiology and contributing factors of this disease is a paramount endeavor researchers continue to explore. The effects of changes in incidence and improved survival on the downward trend in stroke & TIA mortality have not been quantified adequately, chiefly because of the difficulties involved in the accurate measurement of stroke & TIA incidence. Our hypothesis is that the incidence of patients with stroke & TIA is comparatively higher than the general population or other cities in the United States. We also hypothesize that one of the reasons may be the higher prevalence of vascular risk factors.

The primary objective of this study is to identify the patients with known stroke & TIA admitted to hospitals where Texas Tech physicians provide care. The risk factors, treatment and outcome for these patients will be collected retrospectively and analyzed mainly for improvement of current practices.

The study is actively searching for patients at the University Medical Center of El Paso. The study is funded by the Department of Neurology TTUHSC El Paso.

The Primary investigat or (Pl) is Salvador Cruz-Flores, M.D., MPH and co-investigators Jose Gustavo Rodriguez, M.D., Alberto Maud, M.D., Paisith Piriyawat, M.D., Hunter Collins, M.D., lhtesham A Qureshi, M.D., Israel Alba, M.D., Isabel Zuniga, MSN, APRN, AGACNP-BC and Demi Castrellon, MSN, APRN, ACNP-BC.

For more information regarding this clinical trial, please contact the Clinical Research Coordinator, Israel Alba, MBA, CCRP, at lsrael.alba@ttuhsc.edu

Risk of Hemorrhage in patients with Acute lschemic Stroke (AIS) and Cerebral Cavernous Malformation (CCM) following Intravenous Thrombolysis.

lntracranial neoplasms, arteriovenous malformations, aneurysms or previous history of intracranial hemorrhage are contraindications for intravenous thrombolysis in patients presenting with acute ischemic stroke. However, cerebral cavernous malformations (CCM) is a rare condition composed of clusters of endothelial-lined sinusoidal channels filled with blood, at different stages of evolution. They are frequently diagnosed on imaging with a prevalence ranging between 0.1 to 0.8% in general population. Although the most studied factor of CCM's is their natural history, there is very scarce information available to assess the possibility of hemorrhagic complications in patients with acute ischemic stroke (AIS) with concomitant CCM. Concern of potential hemorrhage has often dissuaded clinicians from administering IV tPA in stroke patients with associated CCM, despite the fact that there are no systemic studies available to substantiate the hypothesis. We believe it might not necessarily increase the risk of hemorrhage after administration of IV tPA in subjects with AIS and concomitant CCM.

 

The primary objective of the study is to identify the patients with acute ischemic stroke and concomitant AIS admitted at the Tenet Hospitals of El Paso and at the University Medical Center of El Paso, and to look for the incidence of associated hemorrhage after administration of IV tPA. The outcomes of these patients will be collected retrospectively and analyzed mainly for improvement of clinical practices.

The study is funded by the Department of Neurology TTUHSC El Paso.

The Primary investigator (Pl) is Alberto Maud, M.D., and co-investigators are Salvador Cruz­ Flores, M.D., MPH, Jose Gustavo Rodriguez, M.D., Paisith Piriyawat, M.D., lhtesham A Qureshi, M.D., Mohtashim Arbaab Qureshi, M.D., Mohammed Rauf Afzal, M.D., Darine Kassar, M.D., Anantha Vellipuram, M.D., Rakesh Khatri, M.D.,

For more information regarding this clinical trial, please contact the Clinical Research Coordinator, Israel Alba, MBA, CCRP, at lsrael.alba@ttuhsc.edu

 

Treatment with IV t-PA has been established as an effective treatment for acute ischemic stroke patients treated within the first few hours of symptom onset. Although the treatment window for effectiveness was recently extended from 3 to 4.5 hours, it has been clearly demonstrated that earlier treatment is statistically associated with a higher likelihood of a better outcome. In addition, intra-arterial therapy now has been demonstrated in multiple trials to improve outcomes in acute stroke patients when treated within 6 hours. This had led the AHA/ASA to release guidelines recommending endovascular procedures for selected patients and that systems of care need to be organized to facilitate the delivery of this treatment.

Unfortunately, not all patients eligible for endovascular therapy present to facilities capable of delivering endovascular treatment, and need to be transferred to larger hospitals, most often comprehensive stroke centers for the procedure to be performed. The transfer process is complex and often involves multiple teams of physicians and administrative personnel to coordinate that transfer of the patient. The complexity can often lead to delays in arrival of the patient to the hub and possibly lead to less than ideal outcomes or at times often exclude the patient from the procedure due to the limited time window. Currently, there are no standard time metrics recommended for the IAT transfer process. We therefore aim to describe the current landscape of IAT transfer times at Texas CSCs/lAT-capable stroke centers to identify barriers/delays in the transfer process.

 

We plan to prospectively collect data from participating Texas CSC/IAT- Capable stroke centers regarding patients that were transferred for potential endovascular therapy for acute ischemic stroke.

The aims of the study are to report the time metrics for spoke drip and ship patients transferred to a Texas CSC/IAT-capable stroke center for evaluation of intra-arterial therapy, to identify potential barriers/delays in the transfer process that can lead to delays for drip and ship patients destined for intra-arterial therapy at a Texas CSC/IAT-Capable stroke center and to develop best practice time parameters for patients transferred to Texas CSC/IAT-Capable stroke center for intra-arterial therapy.

 

The study is funded through The University of Texas at San Antonio of the Lone Star Stroke Research Consortium of Texas.

The Primary investigator (Pl) is Salvador Cruz-Flores, M.D., MPH, and co-investigators are Jose Gustavo Rodriguez, M.D., Maud Alberto, M.D, and Rakesh Khatri, M.D.

For more information regarding this clinical trial, please contact the Clinical Research Coordinator, Israel Alba, MBA, CCRP, at lsrael.alba@ttuhsc.edu