/ Not yet recruitingNot Applicable Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation on the Results of Stent Deployment
It is universally accepted that high-pressure balloon inflation is required to most effectively deploy a coronary balloon-expandable stent. However, there is not consensus nor are there any guidelines regarding the method of balloon inflation, particularly the duration of inflation. Underexpansion and strut malapposition after stent deployment are among the most powerful predictors for adverse vessel outcomes. High-pressure inflation for stent deployment is effective to optimally expand the stent, but unlike in vitro testing in air, there are poorly distensible plaque elements that may not instantaneously yield to the balloon pressure. However, these elements may ultimately yield to prolonged inflation. Most clinical interventional cardiologists inflate for a relatively short period (15-30 sec). The investigators have noted that when balloon pressure is maintained at a certain pressure level it tends to decrease over time, and may require 60-180 or more seconds to maintain pressure stability. This finding implies that plaque elements are yielding slowly over time to the increased pressure, thus increasing expansion, and suggests that a prolonged inflation until balloon pressure stabilizes is more effective than a rapid inflation/deflation sequence to fully expand and appose the stent to the vessel wall. At present there is no consensus on stent deployment strategy. It is our hypothesis that prolonged inflation is superior to the more commonly used strategy of rapid inflation/deflation.
Optimal coherence tomography (OCT), a novel technology that measures near-infrared light reflections and translates them into a 2D image, has an axial resolution nearly 10-times that of intravascular ultrasound (IVUS). Thus it is possible to examine the extent of stent malposition and stent expansion using this modality.
The current randomized trial tests the hypothesis that prolonged balloon inflation until a stable balloon pressure is maintained is more effective than a rapid inflation/deflation sequence when performed to the same balloon inflation pressure.
/ RecruitingNot Applicable A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI
This clinical trial is being conducted to see if brain stimulation and brain training together improves cognitive functioning and mood in older adults diagnosed with Mild Cognitive Impairment (MCI). Brain stimulation will be done using repetitive Transcranial Magnetic Stimulation (rTMS). Brain training will be done using immersive virtual reality cognitive training (iVCT) program. The goals of this clinical trail are as follows:
* Examine if rTMS+iVCT intervention can improve and sustain objective cognitive functioning in individuals with MCI more than control or rTMS only groups
* Examine if rTMS+iVCT intervention improves participants mental health symptoms, functional abilities, and quality of life more than control or rTMS only groups
* Examine the impact of rTMS+iVCT intervention on caregiver burden.
Eligible participants will be assigned to a standard treatment (no intervention control) group, rTMS only group of rTMS+iVCT group. All participants will undergo baseline assessment to evaluate their cognitive, emotional, and functional abilities. Those in the rTMS only group will receive rTMS treatments for five days per week for two weeks (total of ten sessions). Those in the rTMS+iVCT group will receive rTMS treatment followed by iVCT training for five days a week for two weeks (total of ten sessions). All participants will then repeat testing 2 weeks and three months after baseline testing to assess for possible treatment related changes and lasting effects.
/ RecruitingNot Applicable DNA Methylation Markers Associated With Exposure and Adverse Health Outcomes in Veterans Exposed to Airborne Hazards From Open Burn Pits
Background: The VA and DoD estimate that 3.5 million Veterans and Service Members were exposed to open burn pits used for waste disposal during military deployments to countries such as Kuwait, Afghanistan, and Iraq since 1990. Since the lasting adverse effects of this exposure on health are unknown, the VA Airborne Hazards and Open Burn Pit Registry (AHOBPR) was created. More than 209,000 participants to date have answered the registry questionnaire about the extent of exposure to burn pits and other airborne hazards. The questions attempted to quantify the duration of exposure, the severity of acute health effects, and the relative timing of onset or worsening of chronic respiratory, cardiovascular, neurological, and other illnesses. However, the AHOBPR interview lacks specific inquiry about mental health and biomarkers. The proposed study will recruit AHOBPR participants and non-participant for a follow-up enhanced evaluation of their health in a translational research study to better characterize their psychological, physical health profile, and potentially harmful epigenetic and biochemical exposure-related alterations.
Hypothesis: The investigators hypothesize that 1) the severity of individual exposure to burn pits will be positively correlated with levels of persistent organic pollutants in blood and metals in urine and specific epigenetic alterations in DNA methylation; and 2) levels of toxic chemicals and alterations in the methylation of specific genes will be positively correlated with chronic problems involving the cardiovascular, respiratory, neuropsychiatric and other systems.
Specific Aims: (1) Describe and quantify relationships of the intensity and duration of exposure with persistent organic chemicals/metals in the registry participants and ascertain their relationships with health outcomes linked to burn pit exposure. (2) Discover and validate DNA methylation marks that best distinguish between individuals exposed to burn pits and those not; then describe and quantify the relationships between DNA methylation, intensity and duration of exposure, and health outcomes. Completion of these aims will allow quantitation of the relationships between toxic chemicals, DNA methylation, and individual health problems.
Study Design: A clinical study will be conducted at the Central Arkansas Veterans Healthcare System and the University of Arkansas for Medical Sciences. The AHOBPR registry and non-specific recruitment will be used to enroll OBP exposed (N=220) and age and gender-matched unexposed (N=110) veterans. The unexposed veterans will be given the same questions as in the AHOBPR to determine their open burn pit exposure status with a confirmation of no exposure. A single study visit per participant will strengthen the registry by validating its contents using the electronic patient record and adding new study data on physical and mental function, including effects of epigenetic and toxicant measures obtained from blood and urine samples. Linear and logistic regression modeling will be used to determine the relationships described by the study aims while controlling for confounding variables and false discovery rates.
Long-term and Short-term Impact on Patient Populations: The immediate goal of the study is to measure exposure-related differences in levels of potentially toxic chemicals present in blood and urine and differences in DNA methylation. The study will then determine the relationships between exposure, the biochemical and molecular measures, and the presence of health problems. The value of this information is high since the effects of burn pit exposure are largely unknown but potentially serious. The longer-term goal for this line of investigation is to enable personalized and tailored health management for exposed individuals. The investigators believe that the biochemical and molecular measures may become novel biomarkers that enable the prediction of risk for disease and adverse disease outcomes such that preventative measures can be employed. Furthermore, the results will be highly relevant to other occupations in which exposure to airborne pollutants is high.
100 Clinical Results associated with Central Arkansas Veterans Healthcare Sys
0 Patents (Medical) associated with Central Arkansas Veterans Healthcare Sys
100 Deals associated with Central Arkansas Veterans Healthcare Sys
100 Translational Medicine associated with Central Arkansas Veterans Healthcare Sys