View clinical trials related to Cardiovascular Disease.
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The study will assess the safety and performance of the Fantom sirolimus eluting bioresorbable vascular scaffold (BVS) in the acute setting of myocardial infarction with unstable lesions and thrombogenic milieu.This is a prospective evaluation of clinical and patient related measures in STEMI patient who undergo urgent primary percutaneous coronary intervention (PCI) with stent implantation. Patients with culprit lesions with 2.5 - 3.5 mm diameter and located in one of the main coronary arteries will be included in the trial and prospectively observed. The study will comprise 20 patients, who will undergo additional evaluation with optical coherence tomography (OCT) and near-infrared spectroscopy/intravascular ultrasound (NIRS/IVUS) at baseline, 6 months, 18-24 months and 36 months. The device will be delivered in sizes 2.5 and 3.0 in diameter / 18 and 24 mm and 3.5 mm x 18 mm in length.
Ineffective hospital discharge communication can significantly impact patient understanding, safety, and treatment adherence. This is especially true for cardiology patients, who leave the hospital with complex discharge plans, a multitude of high-risk medications, post-procedural care instructions and recommendations for drastic lifestyle changes, all delivered in a time-pressured discharge discussion. The goal of this pilot trial is to determine if it is possible to use audio recordings to supplement usual discharge communication to improve cardiology patients' ability to understand and self-manage care after leaving the hospital.
The primary prevention of cardiovascular disease is an unresolved health problem. A sedentary lifestyle and a low cardiorespiratory condition both increase the risk of cardiovascular disease, at a similar extent as that promoted by traditional risk factors, such as smoking, high blood pressure or dyslipidemia. The scientific evidence regarding the effect of the promotion of an active lifestyle on primary cardiovascular prevention is limited. Several studies have shown that structured training programs (TP) are effective at short term, but at the medium or long term their efficacy is still unknown. There are very few randomized controlled trials, and there are almost no studies conducted in the primary care setting which analyze the long-term effects of this type of program on primary cardiovascular prevention. The investigators performed in primary care a previous quasi-experimental study without control group demonstrating the short-term effectiveness in the improvements of both physical condition and in the practice of physical exercise of this TP, the shortest so far analyzed in primary care. With the current study the investigators also want to demonstrate its short-term efficacy in the promotion of moderate-high physical activity and in the practice of physical exercise, through a high-evidence design such as a randomized clinical trial with a control group, also the extension of such efficacy in the medium and long term. Objective: To determine the efficacy of a supervised 2 month TP on short-term (1 month post-TP), medium-term (6 months post-TP) and long-term (12 months post-TP) promotion of moderate-high physical activity and practice of physical exercise, in a sedentary population with high cardiovascular risk, attending primary care centres. Methodology: A parallel, randomized, intervention study, with a control group. Inclusion criteria: Men and women of an age between 35 and 70 years, attending a primary care center in hospital reference area, with high cardiovascular risk. Sedentary lifestyle defined by a score <2 in the brief Physical Activity Questionnaire for care consultations primary adapted to measure the frequency of physical exercise and with a total result in the International Physical Activity Questionnaire (IPAQ)-long version ≤1500 METs x minutes/week, who agree to participate and commit to compliance with the program. Participants were randomized (automated list generation) to a control group, consisting in conventional management or to an intervention group (TP 2 months, 3 times / week). Both groups received an educational talk about cardiovascular risk, healthy diet habits and cardio-healthy exercise at the beginning of TP. Assessments were performed at baseline, and at 3, 8 and 14 months. OUTCOMES: 1. Main outcome measure: differences between groups in the proportion of participants with an "Effective response in Physical Activity ". This effective response was considered if there was an increase ≥ 240 METs x minutes / week in the moderate-high physical activity (measured by IPAQ-long version) in the final evaluation. 2. Secondary outcome variables: differences between groups in the change in: 1. Physical exercise: quantitatively (measured by the sum of the results obtained in items 22-25 of the IPAQ-long version), frequency (Physical Activity Questionnaire for care consultations primary adapted to measure the frequency of physical exercise), and intention (Questionnaire of Stages of Change of Exercise (QSCE)-Short Form). 2. Global physical activity (measured with the total result in the IPAQ-long version). 3. Physical condition: ergometric variables (Peak Oxygen Consumption, exercise duration, anaerobic threshold moment)) and 6 Minute Walk Test. 3. Other efficacy and safety variables: differences between groups in the changes in: 1. Anthropometric variables. 2. Blood pressure. 3. Biochemical parameters. 4. Mediterranean diet (simplified version of the questionnaire ¨Adherence to the Mediterranean Diet¨). 5. Quality of life (questionnaire SF36-long version). 6. Mood (Beck depression index).
This is a single centre, double-blind, randomised, placebo-controlled, parallel staggered group study of BIA 5-1058 in 11 different cohorts of 15 healthy subjects. Subjects will be randomly assigned to receive once-daily oral doses of BIA 5-1058 or matching placebo for 10 days. The primary objectives of the study are to assess the safety and tolerability of BIA 5-1058 after repeated ascending doses under fed and fasted conditions and to assess the pharmacokinetics (PK) of BIA 5-1058 after repeated ascending doses under fed conditions having matching fasting cohorts for comparison of bioavailability. It is planned that comparison cohorts will be dosed in parallel, i.e. Cohorts 1 and 2, 3 and 4, 5 and 6, 7 and 8 and 9 and 10. Cohorts may be split or dosed sequentially for logistical purposes; however, data from both comparison cohorts (e.g. Cohorts 1 and 2) must be available before dose escalation to the next dose levels.
This study will quantify changes in coronary plaque volumes and plaque composition in patients treated with evolocumab. Previous intravascular ultrasound studies have shown that treatment with a lipid-lowering PCSK9 enzyme inhibitor, such as evolocumab, to be associated with a reduction of the fatty deposits that cause plaque in the arteries, however, it is not known how evolocumab affects specific coronary plaque types and plaque inflammation. Investigators will use quantitative assessment of non-invasive coronary computed tomography angiography (CCTA) and positron emission tomography (PET)imaging to evaluate functional changes in plaque burden, plaque composition and vascular inflammation before and after treatment with evolocumab. Investigators propose to show that patients treated with evolocumab in combination with statins demonstrate a greater reduction of coronary non-calcified plaque volume, thereby reducing the number of future cardiac events.
This study aims to assess the effect of puerarin supplementation on cardiovascular disease risk factors in men.
To evaluate the safety, tolerability, PK and immunogenicity of single and multiple ascending doses of MEDI6570 in subjects with Type 2 Diabetes Mellitus
This pilot study will use a hybrid reciprocal peer support and peer coach model to initiate and sustain heart-healthy behavioral changes in Veterans. Veterans who are at-risk for cardiovascular disease (CVD) will be enrolled in the study and paired with another Veteran to receive and provide social support around engaging in CVD risk reduction behaviors. Enrolled participants will be offered a series of 3 group sessions focused on CVD risk reduction, goal setting and action plan development. Between group sessions, peer partners will be asked to have weekly calls to discuss action plan challenges, explore options for problem solving, and provide encouragement and accountability for personal goals. Participants who do not engage in the group sessions or weekly phone calls, or who request additional help, will receive support from trained peer coaches. The goal of this pilot study is to evaluate the proof of concept for a hybrid reciprocal peer support (RPS) and peer coach intervention to improve heart healthy behaviors among Veterans at risk for CVD.
Cardiovascular disease (CVD) is the largest concerns for patients with Chronic kidney disease (CKD). At present time the investigators do not have proven effective strategies to reduce high CVD related deaths in CKD. This study assesses a novel therapy (hydroxychloroquine, HCQ) for the treatment of CVD in patients with CKD. This is the first human proof-of-concept study and is planned to be conducted among US Veterans, who suffer from both CKD and CVD at a disproportionately greater rates. The outcome of this study has the potential to provide an entirely new line of therapy for the treatment of CVD in CKD.