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Exercise Plus Duloxetine for Knee Osteoarthritis
University of Maryland, Baltimore
Knee Osteoarthritis
Depression
This study evaluates the addition of duloxetine to aerobic exercise in the treatment of
symptomatic knee osteoarthritis and depressive symptoms in adults. All participants will
receive the receive the treatment protocol, which will first be evaluated in terms of
feasibility... expand
This study evaluates the addition of duloxetine to aerobic exercise in the treatment of symptomatic knee osteoarthritis and depressive symptoms in adults. All participants will receive the receive the treatment protocol, which will first be evaluated in terms of feasibility and then pilot tested. Type: Interventional Start Date: Oct 2021 |
Hip Muscle Power, Lateral Balance Function, and Falls in Aging
University of Maryland, Baltimore
Accidental Falls
Falls and their consequences are among the major problems in the medical care of older
individuals. The long-term goal of this research is to develop a mechanistically based
therapeutic intervention to enhance muscle power, weight-shifting capability, and lateral
balance function... expand
Falls and their consequences are among the major problems in the medical care of older individuals. The long-term goal of this research is to develop a mechanistically based therapeutic intervention to enhance muscle power, weight-shifting capability, and lateral balance function through protective stepping to prevent falls. When human balance is challenged, protective stepping is a vital strategy for preventing a fall during activities of daily life. Many older people at risk for falls have particular difficulties with successfully stepping sideways as a protective response to loss of balance in the lateral direction. Age-related declines in lateral balance function result from neuromuscular and biomechanical limitations in hip abductor-adductor muscle power generation. This study will test whether these impairments can be improved with high-velocity hip muscle resistance power training that will be more effective than conventional resistance strength training. Type: Interventional Start Date: Sep 2019 |
Title: Leveraging Technology to Address Health Outcomes of Cancer Survivors
University of Maryland, Baltimore
Survivorship
Cancer
Symptoms and Signs
At the end of cancer treatment, many patients are still dealing with symptoms of cancer and
side effects of treatment. Many are also left in a surreal mental state with uncertainty
regarding the future of their health. Survivorship Care Plans are plans that are provided to... expand
At the end of cancer treatment, many patients are still dealing with symptoms of cancer and side effects of treatment. Many are also left in a surreal mental state with uncertainty regarding the future of their health. Survivorship Care Plans are plans that are provided to individuals at the completion of cancer treatment (i.e., chemotherapy, surgery, radiation). Survivorship Care Plans describe the details of a person's diagnosis and treatment, as well as provide recommendations for follow-up appointments, referrals, and healthy behaviors to accelerate recovery and prevent recurrence (e.g., diet, exercise, smoking cessation). Survivorship Care Plans are currently static documents that are provided via paper and become outdated as soon as the person's health status changes. Therefore, there is a need to digitize Survivorship Care Plans to improve the accessibility, modifiability, and longevity of the plan. In addition, with current technology, there is an opportunity for Survivorship Care Plans to be linked with mobile devices and activity trackers so that people can track health behaviors and compare them to their clinical goals, enabling people to take charge of their own health. Charles River Analytics developed an app called POSTHOC (POST-treatment Healthcare Outcomes for Cancer survivors) that digitizes the Survivorship Care Plan with goals to integrate it into the digital medical record. Herein, phase I/II feasibility/preliminary efficacy randomized controlled trial is being conducted among 54 patients with cancer who recently completed adjuvant treatment for cancer (e.g., chemotherapy, radiotherapy, surgery) to compare 12 weeks of the POSTHOC app as part of the Survivorship Care Plan vs. the usual care Survivorship Care Plan on total symptom burden. Participants will be randomized 2:1, POSTHOC:usual care. Those randomized to the POSTHOC group will be provided with their Survivorship Care Plan via the app, and will choose to focus on nutrition or exercise for the duration of the study, based on their individual plan and personal preferences. At baseline, 6 weeks, and 12 weeks, patient-reported outcomes will be evaluated including total symptom burden, diet, and physical activity. Extensive quantitative and qualitative feedback will also be collected on the usability of the app from those in the POSTHOC arm in order to improve the app for future implementation studies. Type: Interventional Start Date: Mar 2024 |
MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia
University of Maryland, Baltimore
Trigeminal Neuralgia
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused
ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type
of pain involving the face that can be disabling to those it affects.
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The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects. Type: Interventional Start Date: Feb 2021 |
Robot Aided Rehabilitation - Multi-joint Evaluations
University of Maryland, Baltimore
Stroke
Sensory and motor impairments following stroke can lead to substantial disability involving
the arm and hand. The investigator hypothesized that excessive local and cross-coupled
stiffness, diminished individuation and proprioceptive acuity will be present among multiple
degree... expand
Sensory and motor impairments following stroke can lead to substantial disability involving the arm and hand. The investigator hypothesized that excessive local and cross-coupled stiffness, diminished individuation and proprioceptive acuity will be present among multiple degree of freedom in the upper limb. The stiffness and spasticity will increase with time post-stroke. The objective of this study is to quantify the progression throughout the arm and hand during recovery from stroke. The investigator will measure the clinical assessment scores, and neuromechanical properties including range of motion, active and passive cross coupling, and spasticity by the IntelliArm robot. Type: Observational Start Date: May 2018 |
Hyperbaric Oxygen Brain Injury Treatment Trial
Hennepin Healthcare Research Institute
Traumatic Brain Injury
The purpose of this innovative adaptive phase II trial design is to determine the optimal
combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate
improvement in the outcome of severe TBI patients in a subsequent phase III trial.
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The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial. Type: Interventional Start Date: Jun 2018 |
Blood-brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Standard of Care Treatment...
InSightec
Brain Tumor
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain
barrier disruption with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain
metastases in patients who are undergoing planned pembrolizumab monotherapy.
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The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned pembrolizumab monotherapy. Type: Interventional Start Date: Aug 2022 |
Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus...
Novartis Pharmaceuticals
Systemic Lupus Erythematosus
The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo,
given as monthly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in
participants with active systemic lupus erythematosus (SLE).
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The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo, given as monthly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE). Type: Interventional Start Date: Apr 2023 |
Retinal Blood Flow and Autoregulation
University of Maryland, Baltimore
Glaucoma
The purpose of this study is to establish autoregulation of retinal blood flow in arterioles
and capillaries as a biomarker for early primary open angle glaucoma.
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The purpose of this study is to establish autoregulation of retinal blood flow in arterioles and capillaries as a biomarker for early primary open angle glaucoma. Type: Interventional Start Date: May 2022 |
Time-Restricted Eating to Address Persistent Cancer-Related Fatigue
University of Maryland, Baltimore
Neoplasms
Therapy
Fatigue
Diet Therapy
Time
This study will assess the feasibility of delivering a 12-week time-restricted eating
intervention as well as the intervention's preliminary efficacy on persistent cancer-related
fatigue among cancer survivors compared to a general health education control. Participants
will... expand
This study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the intervention's preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control. Participants will be randomized 1:1 to one of two arms: time-restricted eating or control. Those in the intervention arm will self-select a 10-hour eating window in which to consume all food and beverages (water is allowed any time, black coffee and unsweetened tea are allowed in the morning). Both groups will receive weekly educational tips on healthy lifestyle behaviors in cancer survivorship. This study will also explore relationships between fatigue, circadian rhythm, and glucose metabolism. The hypothesis is that recruitment will be feasible, and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks. The second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control, accounting for baseline fatigue levels. Type: Interventional Start Date: Jan 2023 |
Recovery After Cerebral Hemorrhage
University of Maryland, Baltimore
Intra Cerebral Hemorrhage
Subarachnoid Hemorrhage
Intraventricular Hemorrhage
Nontraumatic Haemorrhage
Background:
While the intensive care of patients with life-threatening brain illnesses has advanced
tremendously, a large number of therapies are still without proper scientific support.
This can be partly explained by the fact that mechanisms of initial brain injury are... expand
Background: While the intensive care of patients with life-threatening brain illnesses has advanced tremendously, a large number of therapies are still without proper scientific support. This can be partly explained by the fact that mechanisms of initial brain injury are still not well understood. Why additional neurological injury occurs during a patient's stay in the NeuroCritical Care Unit (NCCU) despite current best, evidence-based clinical practices, is also not well understood. However, over the past decade, better tools have become available to measure and monitor the impact of our clinical care on the rapidly changing physiology and chemistry of the injured brain. Some of these tools are CT, MRI, ultrasound, and catheter-based technology measuring blood flow and metabolism. These tools have enabled earlier detection of injury and complications and newer therapeutic strategies. Purpose: Examine disease pathways common to all brain injuries seen in the University of Maryland's 22-bed NCCU. Life-threatening neurological illnesses cared for in the NCCU include massive stroke, bleeding in and around the brain (subarachnoid hemorrhage, intracerebral hemorrhage, subdural hemorrhage, intraventricular hemorrhage), brain tumors, difficult to control seizures, neurologic infections, nerve and muscle diseases (such as myasthenia gravis or Guillain-Barre Syndrome), and spinal cord disorders among others. Many NCCU patients are comatose or paralyzed and may suffer injuries in other parts of the body as well. This effort will require the creation of a robust clinical database for the capture of data including patient characteristics (age, sex), clinical characteristics, medical treatments, surgical interventions, physiological data (such as vital signs, cerebral blood flow, intracranial pressure, cerebral oximetry, etc), laboratory data, and standard-of-care diagnostic studies such as electroencephalography (EEG), ultrasound, CT, MRI, and angiograms. Similar databases exist at other major centers for neurocritical care and have been instrumental to the identification of characteristics both predictive of and associated with outcomes of patients long after their stay in the NCCU. In addition, the samples collected will be included in the University of Maryland Medicine (UMM) Biorepository which is a shared resource to enable biomedical research by University of Maryland faculty. Type: Observational [Patient Registry] Start Date: Sep 2014 |
Pulmonary Hypertension Association Registry
Pulmonary Hypertension Association, Inc.
Pulmonary Arterial Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Pulmonary Hypertension
The PHA Registry (PHAR) is a national study about people who have pulmonary arterial
hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). PHAR collects
information from people with PAH and CTEPH who are cared for in participating PHA-accredited
Pulmonary... expand
The PHA Registry (PHAR) is a national study about people who have pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). PHAR collects information from people with PAH and CTEPH who are cared for in participating PHA-accredited Pulmonary Hypertension Care Centers throughout the U.S. PHAR will determine how people with PAH and CTEPH are evaluated, tested, and treated, and will observe how well these participants do. The goal is to see if people with PH are treated according to recommended guidelines, and to see if there are certain factors that can lead to better or worse outcomes. PHAR will include information about people with PAH and CTEPH in the U.S. who are seen at participating PHA-accredited PH Care Centers. PHAR contains data about patient care and outcomes. Specifically, data in the PHAR includes information on diagnosis; clinical status; socioeconomic status; diagnosis test results; body size; treatment information; interest in participating in clinical trials; family health and social history; and information about smoking, alcohol, or drug use. Participants are followed over time, and provide updates such as changes in therapy, how often participants need to go to the hospital, and survival. Such information may help healthcare providers provide better care. Type: Observational [Patient Registry] Start Date: Oct 2015 |
Sleep for Stroke Management and Recovery Trial
University of Michigan
Ischemic Stroke
Sleep Apnea
Sleep Apnea, Obstructive
TIA
Stroke
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA)
with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA
(1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after... expand
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke. Type: Interventional Start Date: May 2019 |
Gastroschisis Outcomes of Delivery (GOOD) Study
Medical College of Wisconsin
Gastroschisis
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7
weeks in stable patients with gastroschisis is superior to observation and expectant
management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will
complete... expand
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days. Type: Interventional Start Date: Feb 2018 |
Diaphragm Structure and Function in Childhood Cancer Survivors
University of Maryland, Baltimore
Childhood Cancer
Cancer Survivors
The purpose of this research is to study the feasibility of a specific training program for
the breathing muscles (inspiratory muscle training) and the effects on how breathing is
regulated during exercise in childhood cancer survivors.
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The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in childhood cancer survivors. Type: Interventional Start Date: Mar 2024 |
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
University of Illinois at Chicago
Corneal Ulcer
The proposed Conventional Cohort Expansion Study involves the use of Mesenchymal Stromal
Cells (MSCs) are derived from the bone marrow. We previously studied the safety of
subconjunctival injection of allogeneic bone marrow-derived MSCs in patients with nonhealing
epitheliopathy... expand
The proposed Conventional Cohort Expansion Study involves the use of Mesenchymal Stromal Cells (MSCs) are derived from the bone marrow. We previously studied the safety of subconjunctival injection of allogeneic bone marrow-derived MSCs in patients with nonhealing epitheliopathy (IRB Protocol 2020-0334). In the present study, we want to study the efficacy of this treatment on chronic epitheliopathies. Type: Interventional Start Date: Sep 2023 |
A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed...
Hoffmann-La Roche
Multiple Myeloma
This study will evaluate the efficacy, safety, and pharmacokinetics of cevostamab in
participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV)
infusion.
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This study will evaluate the efficacy, safety, and pharmacokinetics of cevostamab in participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion. Type: Interventional Start Date: Oct 2022 |
DMID 21-0041; Influenza CVD 59000
University of Maryland, Baltimore
Influenza
The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to
implement interventions which are known to reduce inhalation (airborne) transmission, so that
the contribution of transmission by route of aerosols for influenza may be identified.
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The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to implement interventions which are known to reduce inhalation (airborne) transmission, so that the contribution of transmission by route of aerosols for influenza may be identified. Type: Interventional Start Date: Feb 2023 |
The Effects of Fluoxetine and/or DHEA
University of Maryland, Baltimore
Type 1 Diabetes Mellitus
(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac),
an antidepressant often used to treat depression, stimulates the participant's body's ability
to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone,
dehydroepiandrosterone... expand
(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates the participant's body's ability to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone, dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body. However, it can be manufactured and is sold as an over-the-counter dietary supplement. The dose the investigators are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions. (3) To study combined effects of fluoxetine and DHEA during low blood glucose. In the present study, the investigators will measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64 individuals with type 1 diabetes will take part in this study. Type: Interventional Start Date: Dec 2017 |
Robot Aided Rehabilitation - Intervention
University of Maryland, Baltimore
Stroke
Sensorimotor impairments following stroke often involve complex pathological changes across
multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them
difficult to diagnose and treat. The objective of this study is to evaluate multi-joint
neuromechanical... expand
Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment, and determine the effects of arm versus hand training and the effects of passive stretching before active movement training. Type: Interventional Start Date: Oct 2018 |
Working Memory and Physical Exercise Training in Patients With Mild Cognitive Impairment
University of Maryland, Baltimore
Mild Cognitive Impairment
The prevalence of dementia will double in the next three decades in the U.S.; effective
treatment or prevention for dementia is urgently needed. The current exploratory project aims
to evaluate and understand how the brain and cognition may improve after a 12-week
intervention... expand
The prevalence of dementia will double in the next three decades in the U.S.; effective treatment or prevention for dementia is urgently needed. The current exploratory project aims to evaluate and understand how the brain and cognition may improve after a 12-week intervention that combines brain training and aerobic exercise training to improve brain function, both in those with mild cognitive impairment (some with possible prodromal Alzheimer's disease) and with healthy aging. Findings from this pilot project will guide and refine the development of a future larger clinical trial that aligns with the goals of the National Alzheimer's Plan of Action (NAPA), especially regarding "Prevent and Effectively Treat Alzheimer's Disease (AD) by 2025. Type: Interventional Start Date: Jan 2024 |
ICG Fluorescence Imaging in Post-traumatic Infection
Dartmouth-Hitchcock Medical Center
Trauma Injury
The focus of this prospective observational study is to (1) establish the range and variation
associated with bone/soft tissue perfusion in fracture patients, using ICG fluorescence
imaging; (2) examine the relationship between perfusion and complications such as surgical... expand
The focus of this prospective observational study is to (1) establish the range and variation associated with bone/soft tissue perfusion in fracture patients, using ICG fluorescence imaging; (2) examine the relationship between perfusion and complications such as surgical site infection (SSI), persistent SSI, and fracture nonunion; (3) to determine whether the quantitative ICG fluorescence can be used to guide bony debridement in the setting of infected fracture to minimize complications. Type: Observational [Patient Registry] Start Date: Sep 2020 |
FastFrame Knee Spanning and Damage Control Kit PMCF
Zimmer Biomet
Fracture
Fractures, Bone
Fractures, Closed
Fractures, Open
The purpose of this prospective study is to confirm safety and performance of the FastFrame
External Fixation System and corresponding instrumentation.
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The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation. Type: Interventional Start Date: Jun 2021 |
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve...
Abbott Medical Devices
Mitral Regurgitation
Mitral Insufficiency
Mitral Valve Insufficiency
Cardiovascular Diseases
Valve Disease, Heart
Prospective, controlled, multicenter clinical investigation with four trial cohorts:
Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral
Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort
will be... expand
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts will receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years. Type: Interventional Start Date: Jun 2018 |
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Thomas G. Brott, M.D.
Carotid Stenosis
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent
multicenter, randomized controlled trials of carotid revascularization and intensive medical
management versus medical management alone in patients with asymptomatic high-grade carotid... expand
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed. Type: Interventional Start Date: Dec 2014 |