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Cardiovascular Disease clinical trials

View clinical trials related to Cardiovascular Disease.

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NCT ID: NCT02188121 Completed - Schizophrenia Clinical Trials

Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients

FITNESS
Start date: February 2015
Phase: Phase 4
Study type: Interventional

Patients with severe mental illness (SMI) die younger than persons in the general population. Much of the excess mortality for SMI patients is attributable to cardiovascular disease, and is exacerbated by treatment with second-generation antipsychotics (2GAs). Although the cardiovascular risks are well-known, and safe, efficacious therapy exists, few SMI patients receive cardiovascular prevention drugs. Care delivery fragmentation and poor patient adherence are central problems to reducing cardiovascular risks for patients with SMI. To address these problems, we propose to conduct a multi-site, open-label, randomized controlled trial comparing an initial treatment strategy of free, fixed-doses of two generic, cardiovascular prevention drugs (statins and angiotensin drugs) delivered within mental health clinics versus usual treatment. The study will include adult patients (18+ years old) with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, or psychosis not otherwise specified (NOS) who have received 2GAs treatment within the past six months from within four mental health clinics in the Boston area. We have three aims: 1) to compare the proportions of subjects in each arm who are receiving cardiovascular drug treatment and are adherent to therapy during 12-months of follow-up; 2) to compare changes in composite (e.g., Framingham scores) and individual (e.g., lipid levels) cardiovascular risk factor levels using an intent-to-treat (ITT) approach; and 3) to compare risk factor levels, accounting for variation in adherence over time, using causal inference techniques to estimate the per-protocol effect of the intervention. Our three aims examine whether this low cost, streamlined treatment strategy increases the numbers of subjects receiving cardiovascular prevention therapy and improves cardiovascular risk levels. We will follow subjects for 12 months, and collect interview and biometric data at baseline and over the following 12 months. Subjects will have the option to continue for another 12 months, during which we will continue to collect interview and biometric data, but will not prescribe cardiovascular medications. This population-based initial treatment strategy could be an effective and efficient approach for overcoming traditional barriers to cardiovascular disease prevention within the SMI population. Findings from this study will inform efforts to improve care and outcomes, and to enhance survival for patients with severe mental illness.

NCT ID: NCT02187172 Completed - Psoriasis Clinical Trials

Vascular Inflammation in Psoriasis-Ustekinumab (VIP-U)

VIP-U
Start date: July 2014
Phase: Phase 4
Study type: Interventional

The VIP-U Study is a clinical trial designed to investigate the effect of ustekinumab (Stelara) and placebo on reducing vascular inflammation and cardiometabolic risk biomarkers in patients with moderate to severe psoriasis. This study will look for systemic vascular inflammation in study participants with a test called FDG PET/CT (fluorodeoxyglucose-positron emission tomography/computed tomography). The study will also look for cardiometabolic identifiers (heart disease and metabolic factors) in blood samples, including markers of high cholesterol, cholesterol efflux function (the ability of cholesterol to move in the body), metabolic factors, and inflammation. The study will also examine the effects of ustekinumab compared to placebo on psoriasis activity, severity and safety.

NCT ID: NCT02186353 Withdrawn - Diabetes Clinical Trials

Processing Responses of Grains (PRO-Grains) Study

Start date: September 2014
Phase: N/A
Study type: Interventional

The primary objective of this pilot study will be to examine the effects of consuming whole grains, differing in the degree of processing, on insulin sensitivity and other cardiometabolic risk factors. The overall aim will be to assess feasibility of the test diets and to generate preliminary data.

NCT ID: NCT02180841 Completed - Clinical trials for Cardiovascular Disease

Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness

SOY
Start date: March 2014
Phase: N/A
Study type: Interventional

The purpose of the proposed pilot study is to evaluate the effects of a soy protein isolate with naturally occurring isoflavones on the properties of HDL-C (total HDL-C, HDL particle size and HDL function), central blood pressure, and indices of arterial stiffness.

NCT ID: NCT02180074 Completed - Clinical trials for Cardiovascular Disease

Measurement of Distinct Biological Pools of Hydrogen Sulfide in Women With Cardiovascular Disease

Start date: September 2013
Phase:
Study type: Observational

Cardiovascular disease which includes coronary artery disease and peripheral artery disease remains the leading cause of death among women in the United States. The impact of cardiovascular in women was not recognized by clinicians for a long time. It is now evident that, women suffer the consequences of cardiovascular at rates at least as high as those observed in men but there are still major gaps in our understanding this disease in women. Hydrogen sulfide (H2S), a gaseous mediator plays an important role in the cardiovascular system. Research has demonstrated it's critical role in animal ischemia reperfusion models. Hydrogen sulfide exists in distinct biological pools in blood. Recently, the Kevil lab has pioneered the development of new analytical techniques for accurate measurement of all biological pools of H2S. By measuring these distinct pools of H2S in women with and without cardiovascular disease the investigators hope to further understanding of role of H2S in pathophysiology of cardiovascular disease. This research will help to assess the ability of H2S and its distinct biological pools to potentially be a diagnostic marker or a therapeutic target for cardiovascular disease.

NCT ID: NCT02178930 Completed - HIV Clinical Trials

HealthMap: an Interactive Health Plan Randomised Trial to Prevent Cardiovascular Disease in People With HIV

Start date: August 1, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to improve the health status of people living with HIV in Australia. The overall goal is to rigorously evaluate the impact of interactive health plans and self-management support on chronic condition outcomes in people with HIV. The specific aims are to: Aim 1: Using a doctor-level cluster randomised trial, evaluate the effect of interactive health plans and self-management support on coronary heart disease risk and other chronic condition outcomes in people living with HIV. Aim 2: Evaluate patient and health care provider experiences and acceptability of interactive health plans and self-management support. Aim 3: Evaluate intervention cost-effectiveness and effect on health service utilisation.

NCT ID: NCT02178410 Active, not recruiting - Clinical trials for Cardiovascular Disease

VITAL Rhythm Study

Start date: October 2012
Phase: Phase 3
Study type: Interventional

The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing randomized clinical trial of 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in individuals who do not have a prior history of these illnesses. The purpose of this ancillary study is to ascertain and adjudicate atrial fibrillation (AF) outcomes for the primary aim of testing whether omega-3 fatty acid and/or vitamin D supplementation influence atrial fibrillation risk in the general population. We also plan to examine how these agents might impact the development of AF subtypes (persistent versus paroxysmal), intermediate phenotypes for heart rhythm disorders (electrocardiographic parameters), as well as explore effects on arrhythmic death and whether baseline blood levels and/or race modify treatment effects.

NCT ID: NCT02173366 Completed - Obesity Clinical Trials

Change Clubs for African American Women

Start date: December 2013
Phase: N/A
Study type: Interventional

African American women have among the highest rates of overweight and obesity and few meet dietary or physical activity guidelines. The investigators seek to develop a new intervention strategy that will help alleviate health disparities, thereby improving quality of life, health care costs, and disease burden. The African American Collaborative Obesity Research Network (AACORN) recommends an eco-social, community-engaged approach to behavior change that is in line with cultural values of interconnectedness and care for others. The purpose of this study is to operationalize the AACORN paradigm to promote improvements in weight status and health through a civic engagement approach. To achieve this, participants will meet in church-based Change Clubs and be led through a 6 month curriculum, which includes both lessons in cardiovascular risk reduction and a civic engagement project. Civic engagement may lead to change in individual health behaviors by increasing self-regulation and self-efficacy. The investigators will measure club members' adherence to the Change Club intervention, defined as average number of sessions attended, retention in the clubs, satisfaction with the Change Club experience and achievement of at least 50% of self-identified benchmarks for community change within 6 months. In addition the investigators will compare anthropometric factors, diet and physical activity behaviors, blood pressure, cardiorespiratory fitness, and psychosocial factors before and after participation in the Change Club intervention.

NCT ID: NCT02163031 Completed - Clinical trials for Cardiovascular Disease

Left vs. Right Radial Approach for Routine Catheterization of Heart Transplant Patients

Start date: June 2014
Phase: N/A
Study type: Interventional

Orthotopic heart transplantation is a well established therapeutic measure for end stage heart failure, leading to significant improvements in survival and quality of life. In the routine clinical practice, orthotopic heart transplantation patients receive periodic cardiac catheterization for early detection of allograft vascular disease. The coronary angiography of these patients is characterized for several technical difficulties, generally related to the presence of the aortotomy with anomalous implantation of the coronary ostia and to the orthotopic position of the allograft. For these reasons, trans femoral approach is usually preferred. In the last two decades, trans radial approach for coronary angiography emerged to be effective, safe and able to improve patient comfort. However, there is no universal consensus on the optimal choice of radial access from either the left or the right artery. Currently, this choice is largely dependent on the operator's preference. The trans right radial approach is generally preferred in routine clinical practice mainly due to its easier catheter manipulation for the operators from patient's right side, and the current design of radial compression devices for the right wrist in medical market. As such, a major barrier to prevent the wide adoption of the left radial access lies in some difficulty to reach the left wrist leaning over the patient, particularly for shorter operators or in obese patients. However, a great deal of attention has been recently directed toward the trans left radial access, as it has an important anatomical advantage due to the vascular anatomy of epiaortic vessels with a straighter route to the left coronary ostium, which could also reduce the risk of cerebrovascular complications. However, no data are available about the performance of trans left radial or trans-right radial approach in coronary angiography orthotopic heart transplantation patients. However, in this particular setting of patients, the left radial approach might reduce the technical difficulties related to the anatomical variations. In this single centre, prospective, randomized study, we sought to compare trans right radial versus trans left radial approach in terms of amount of contrast medium, radiation exposure, number of catheters used, cross over to the other access site rate and local and systemic complications in orthotopic heart transplantation patients.

NCT ID: NCT02156284 Completed - Clinical trials for Cardiovascular Disease

Nurse Empathic Behaviour to Reduce the Fear in Patients of Preoperative Cardiac Surgery

Start date: May 2011
Phase: N/A
Study type: Interventional

The objective was to compare the frequency and intensity of symptoms of fear in patients of preoperative cardiac surgery who received empathic behaviour from nurse or those who received no specific type of empathic behaviour. This is a randomized clinical trial. The sample consisted of 44 patients in preoperative of cardiac surgery, who were divided in two groups: empathic behaviour by nurses and without specific empathic behaviour. Fear was assessed at two time points: before and after the intervention. The instrument used was developed and validated, comprising 15 defining characteristics of the nursing diagnosis fear. The hypothesis is that the group who received empathic behaviour from nurse will reduce the anxiety.