View clinical trials related to Cardiovascular Diseases.
Filter by:The purpose of this multicenter, two component observational and standardized case-control study is to evaluate risk factors of gastrointestinal (GI) bleeding with a prospective 3-month and 12-month follow-up to examine outcomes and their possible causes.
Research has shown that persons who have trouble sleeping and experience stress are at risk of developing heart diseases. Two treatments, called stimulus control instructions and sleep efficiency treatment, that do not involve sleeping pills, have been found effective in managing trouble sleeping. This study will be undertaken to find out if the two treatments are effective in improving sleep, and reducing stress and the risk of heart diseases. Persons with trouble sleeping may have a preference for either treatment. It is believed that if persons get the treatment they prefer, then they will be satisfied with the treatment and comply with it, and experience improvement in their sleep. This study will also examine the extent to which giving persons the treatment of their choice, as compared to giving persons treatment based on chance, will lead to higher satisfaction and compliance with treatment, and improved sleep. About 300 persons who experience trouble sleeping will be included in the study. They will be requested to complete a questionnaire and a sleep diary before and after they receive treatment, as well as 6 month and one year later.
Social determinants of health (e.g. the income, education, and environment of patients) may exert greater influence on health outcomes than traditional clinical factors (e.g. lab results, diagnoses, and family history). Calls for integrating primary care and public health are therefore increasing, but merging these domains of care is logistically difficult. Research is lacking on the incremental benefit of adding public health data at the practice level-- in improving either health outcomes or care delivery. This proof of concept pilot will merge data from electronic health records (EHRs) with community vital signs, a set of metrics that describes key community resources that affect health. The investigators will identify resource poor communities, or cold spots, based on four variables (education, poverty, life expectancy, and access to healthy foods) at the census tract level - referred to as a community vital sign. The hypothesis is that patients coming from cold spots are more likely to have worse health outcomes and that clinicians will deliver better care if they know a patient's community context and his/her specific social needs. This study will involve 12 primary care practices in Northern Virginia that care for more than 170,000 patients. Patient addresses will be geocoded for each practice and determine which patients reside in cold spots for each community vital sign. The variation for each community vital sign for each practice's patients will be calculated and a bivariate and regression analyses will be used to determine whether coming from a cold spot is associated with worse clinical quality metrics. 15 clinicians will be alerted when they see a patient from a cold spot, patients will complete a social needs survey, and clinicians will prospectively document through surveys whether such knowledge affects interpersonal interactions (such as time spent with patients and the use of clearer language) or clinical management (such as referrals to care coordination or community resources). By pragmatically integrating community vital signs into care, this innovative proposal will seek to understand which community data clinicians value, how these data might influence care, and how best to incorporate these data into clinical and population care.
Investigation of the acute effects of a single dose of Careless™, a Mangifera indica fruit powder on cutaneous microcirculation and endothelial function.
The Miami Heart Study at Baptist Health will be an observational, longitudinal and prospective cohort study in a target population of 4000 healthy subjects (40-65 years old) consisting of members from the Greater Miami Area (including eligible BHSF(Baptist Health South Florida) employees). Baseline examination will consist of (1) assessment for cardiovascular risk factors (including lifestyle and psychosocial factors); (2) screening for subclinical atherosclerosis using Coronary CT angiogram, Coronary Artery Calcium (CAC) testing, vascular 2D/3D ultrasound, endothelial function, arterial stiffness and (3) blood sampling for determination of traditional risk factors, advanced "omics" and biobanking. Participants will be followed yearly via telephone, email, or mail for change in health status with a focus on cardiovascular disease events, including acute myocardial infarction and other forms of coronary heart disease (CHD), stroke, and congestive heart failure; mortality; and for cardiovascular disease interventions. The Miami Heart Study at Baptist Health is expected to identify new imaging and biological factors associated with the presence and feature of earliest markers of subclinical atherosclerotic disease and provide opportunities for discovery/validation of novel biomarkers to identify these high-risk features. This is expected to lead to advances in understanding of evolution and progression of atherosclerotic cardiovascular disease starts with an ultimate goal of establishing more personalized, evidence-based approach to medical care.
This is a randomized, prospective, open label study to determine the cost-effectiveness of genotype-guided antiplatelet therapy. Patients undergoing percutaneous intervention (PCI) with stent implantation, will be randomized either to genotype guided dosing of antiplatelet therapy or usual care. The study utilizes a novel genotyping device, SpartanRx, to determine CYP2C19 genotypes from a buccal swab sample with 1 hour turnaround time.
This study has been designed as a randomized, double-blind trial to provide definitive evidence on the effects of ticagrelor and prasugrel on myocardial salvage in patients with anterior ST Segment Elevation Myocardial Infarction (STEMI) undergoing primary Percutaneous Coronary Intervention (PCI). This study will also measure the effects of ticagrelor vs. prasugrel on secondary endpoints listed above. This study design aims to test the hypothesis that ticagrelor will reduce myocardial infarct size as a proportion of the ischemic area at risk when compared to prasugrel.
Background: It is still difficult to predict the outcome in patients requiring Fontan Revisions and in those who have evidence of congestive hepatopathy and probable cirrhosis requiring major cardiac surgery including heart transplant. Over the years, many prognostic indices have been derived from laboratory results of blood tests, clinical and physiological variables (or some combination thereof), from liver imaging to liver histology, which has issues of sampling error, medical risks and technical difficulty. None of these have proved entirely satisfactory. Predicting morbidity or survival is particularly important when deciding about Fontan revisions versus the need for heart transplantation. What is needed here is a truly reliable test of liver function that can help predict outcome, on the basis of a single measurement within few days of a planned revision. For this purpose, it is desirable that the chosen tests of liver performance be safe, non-invasive, easy to perform, have a rapid turnaround for results, and be readily repeatable. Tests of hepatic elimination of various exogenous substances have been described, such as galactose elimination capacity (GEC), indocyanine green (ICG) clearance, lidocaine metabolism to monoethylglycinexylidide (MEGX), and other tests that rely on liver metabolic capacity. None of these metabolic or clearance tests achieved widespread acceptance or use, mostly because their performance and analyses were cumbersome. HepQuant,LLC has developed a platform of tests of liver function which include Systemic Hepatic Filtration Rate (HFR), Portal HFR, SHUNT, and Disease Severity Index (DSI)1,2. HepQuant tests specifically target the hepatic uptake of cholate and use a single noninvasive test of 90 minutes duration to quantify the systemic circulation, portal circulation, and portal-systemic shunt and to derive a DSI in intact human subjects. HepQuant tests can assess all stages and etiologies of liver disease. In chronic HCV patients HepQuant testing can predict which patients will respond to antiviral therapy and can measure the improvement in hepatic function that occurs after successful antiviral therapy. Patients who did not respond were followed for an average of 5 years and up to 8 years, and baseline HepQuant testing could predict clinical outcomes (CTP progression, variceal bleeding, encephalopathy, ascites, liver-related death) with 87% sensitivity and 71% specificity.
Clopidogrel is a potent anti-thrombotic drug that inhibits adenosine diphosphate (ADP)-induced platelet aggregation. This is an open-label, randomized, single dose, three-way cross over, six sequence study to investigate the relative bioavailability of two 75 milligrams (mg) clopidogrel tablet formulations (clopidogrel SB224326 test formulation 1 [Clop F1] and clopidogrel SB224326 test formulation 2 [Clop F2]) compared with the reference product (innovator) in healthy human subjects. A total of 18 healthy human subjects will be randomized, such that approximately 14 evaluable subjects complete the study. Total duration in the study for each subject will be approximately 8 weeks from screening to the follow-up visit.
Specific Aims: Bridging Income Generation with GrouP Integrated Care (BIGPIC) Over 80% of cardiovascular disease (CVD) deaths occur in low- and middle-income countries (LMICs). Diabetes, a major risk factor for CVD, is also responsible for substantial morbidity and mortality in LMICs. Elevated blood pressure (BP) increases CVD risk among individuals with diabetes and pre-diabetes; BP control is therefore a powerful way to reduce CVD risk. Cost-effective, culturally appropriate, and context-specific approaches are critical. Two promising strategies to improve health outcomes are group medical visits and microfinance. Both can increase quality of care, clinician-patient trust, self-efficacy, health savings, self-confidence, group cohesion, and social support. While these strategies have been successful in other contexts, their impact on CVD risk reduction among diabetics and pre-diabetics in low-resource settings is not known. In partnership with the Government of Kenya, the Academic Model Providing Access to Healthcare (AMPATH) Partnership has expanded its clinical scope of work to include diabetes and hypertension. AMPATH has piloted group care and microfinance initiatives among patients with chronic diseases with promising early results. Both strategies are feasible, as is integration of group medical visits into microfinance groups. However, the effectiveness of these strategies individually, and in combination, on improving CVD risk is not known. Thus, the objective of this proposal is to utilize a transdisciplinary implementation research approach to address the challenge of reducing CVD risk in low-resource settings. The central hypothesis is: group medical visits integrated into microfinance groups will be effective and cost-effective in reducing CVD risk among individuals with diabetes and at increased risk for diabetes in western Kenya, and that the key modifiable CVD risk factor to be addressed is BP. The research team hypothesize that group medical visits and microfinance may each reduce CVD risk, but the integration of group medical visits and microfinance will yield the largest gains. Also further hypothesize is that changes in social network characteristics may mediate the impact of interventions on the primary outcome, and that baseline social network characteristics may moderate the impact of interventions. To test these hypotheses and achieve the overall objectives, the following specific aims will be pursued: Aim 1: Identify the contextual factors, facilitators, and barriers that may impact integration of group medical visits and microfinance for CVD risk reduction, using a combination of qualitative research methods: 1) baraza (traditional community gathering) form of inquiry; and 2) focus group discussions among individuals with diabetes or at increased risk for diabetes, microfinance group members, and rural health workers. Subsidiary Aim 1.1: Use identified facilitators and barriers to develop a contextually and culturally appropriate integrated group medical visit-microfinance model to reduce CVD risk among individuals with diabetes or at increased risk of diabetes. This model's acceptability and feasibility will be assessed by conducting focus group discussions with patients, microfinance group members, and health workers. Aim 2: Evaluate the effectiveness of group medical visits and microfinance groups for CVD risk reduction among individuals with diabetes or at increased risk for diabetes, by conducting a four-arm cluster randomized trial comparing: 1) usual clinical care; 2) usual clinical care plus microfinance groups only; 3) group medical visits only (no microfinance); and 4) group medical visits integrated into microfinance groups. The primary outcome measure will be one-year change in systolic blood pressure (SBP), and a key secondary outcome will be change in QRISK2 CVD risk score, which has been validated for Black Africans. Subsidiary Aim 2.1: Conduct mediation analysis to evaluate the influence of changes in social network characteristics on intermediate factors and intervention outcomes and moderation analysis to evaluate the influence of baseline social network characteristics on effectiveness of interventions. Aim 3: Evaluate the incremental cost-effectiveness of each intervention arm of the trial, in terms of costs per unit decrease in SBP, per percent change in CVD risk score, and per disability-adjusted life year saved. This research project will add to the existing knowledge base on innovative, scalable, and sustainable strategies for reducing CVD risk in diabetes and other chronic diseases in LMICs and other low-resource settings. If proven to be effective, the investigators are poised to expand the approach beyond the trial, thus ensuring that this research will have a significant and positive health impact on a larger population.