View clinical trials related to Cardiovascular Diseases.
Filter by:Investigation of the acute effects of a single dose of Careless™, a Mangifera indica fruit powder on cutaneous microcirculation and endothelial function.
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.
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.
Strong Hearts, Healthy Communities is a research study which aims to reduce cardiovascular disease (CVD), improve quality of life, and reduce CVD related health care costs in rural communities. The investigators' aim is to better understand how changes in lifestyle can affect the health of rural women and others in their communities.
Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites across China, the primary endpoint is Technical success.
Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.
The purpose of the study is to investigate the preservation or promotion of health in students during the college years.
This study will investigate the effects of Leukocyte reduced cold-stored platelet transfusions used in treatment of immediate postoperative blood loss in patients undergoing thoracic surgery in combination with extracorporal circulation. Today platelet concentrates are stored at 22 degrees C . This is a prospective, randomized, unblinded, non-inferiority two-arm study. Aim of study is to compare platelet function in bleeding patients transfused with leukoreduced platelet concentrates stored cold (4 degrees C) and in room temperature (22 degrees C). Storage time for RCT platelet concentrates are up to 7 days. Patients with expected time on extracorporal circulation more than 120 minutes and/or medical platelet inhibitors will be included. Platelet function will be assessed by use of Multiplate Aggregometry, Thromboelastography (TEG) and/or Thromboelastometry (ROTEM). In addition post operative bleeding, and adverse events will be recorded. After completion of recruitment of patients to RCT study of platelet stored cold for up to 7 days, a follow up prospective observational study of platelets stored cold for up to 14 days is performed. Additonal information 2019, May 03: This trial was registered on Clinical Trials.gov with an original plan to use non-inferiority testing of between-group differences in platelet function. Due to lack of evidence needed to set acceptable tolerance margins for the non-inferiority testing, independent reviewers with expertise in clinical trial design recommended they be replaced by standard tests of superiority, commensurate with the early phase of the trial. Further, post-operative chest tube drainage was chosen as the primary outcome to better present the pilot study's focus on the control of clinically significant bleeding.