View clinical trials related to Cardiovascular Diseases.
Filter by:This is an early feasibility, non-randomized, open-label, single group, interventional study to be conducted in up to 20 US subjects to evaluate the technical feasibility of the Durablate Catheter and Thermedical Ablation System to eliminate or control sustained, monomorphic ventricular tachycardia (VT) in patients with VT refractory to drug and conventional catheter ablation with acceptable procedural safety.
This is a phase IV, randomized (1:1), prospective, double-blind, placebo controlled, parallel-group, single center study at the Clinical Research Unit (CRC) of the Department of Nephrology and Hypertension, with its two separate locations: - Nürnberg, Kreuzburger Str. 2, 90471 Nürnberg, and - Erlangen, Ulmenweg 18, 91054 Erlangen The results of this study provide strong support for the concept that it is lower LDL-C levels that is key to achieving better outcomes, and that it is possible to achieve these on top of statin therapy (despite the much debated potential "pleiotropic" effects of statins). At least 65 patients will be randomized (1:1) and included (informed consent) in order to obtain 58 fully evaluable subjects (29 with evolocumab, 29 with placebo). Patients will be simultaneously recruited from investigator's outpatient clinics, referring physicians, and advertisement in local newspapers, and social media. Those patients that appear to potentially fulfill the inclusion criteria will be invited to a screening visit. After providing informed consent, patients will be tested for inclusion/exclusion criteria and for feasibility of vascular measurements (in particular to ensure that adequate imaging of the brachial artery is possible). Patients will provide a blood sample for laboratory testing. If the patient then fulfills inclusion criteria and in the absence of exclusion criteria, the patient will be enrolled into the trial, and the study visits will be scheduled. Randomization will take place at the latest one day prior to the study visit 2 (e.g. at the latest at visit 2a). At visit 2, baseline vascular function parameters will be obtained and the patient will be given an SC injection of the study drug (either SC 420 mg evolocumab or SC placebo). At visit 4, the second injection of study drug will be administered. After 1, 4 and 8 weeks of treatment (visits 3, 4 and 5), testing of vascular function will be repeated. At visit 6, a final close out visits will be performed to gather additional safety information.
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in subjects with elevated plasma Lipoprotein(a) [Lp(a)]. AMG 890 will be evaluated in approximately 80 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.
Remote Ischaemic preconditioning' (RIPC) is defined as short controlled sequences of repeated inflation of a blood pressure cuff on the upper arm (to reduce blood flow) for 5 mins followed by recovery (cuff deflation so blood flows normally again). An intervention consisting of 4 cycles of 5 min of arm cuff inflation followed by deflation performed 3 times per week, spread over 8 weeks has been shown to improve blood vessel function in young individuals without any medical conditions. This is a simple and easily applicable intervention that could help the blood vessels capacity to deliver blood to an organ (e.g. heart or the muscle).It is currently unknown if RIPC combined with exercise training, provides stronger benefits to our blood vessels than RIPC alone. Therefore, the aim of this study is to investigate if combining RIPC with an 8 week exercise training programme improves blood vessel health more than 8 weeks of RIPC alone.
Optiflow (high flow humified nasal oxygen) is used in several settings frequently (ICU, during elective general anaesthesia- commonly here on the TOE list, in certain ENT patients, and more commonly now in obese or obstetric patients for preoxygenation). To the investigators knowledge no one has quantified the common complications associated with it (based on a literature search in November 2017 using PubMed and Google; using the search terms "high flow nasal oxygen" combined with "complications", "side effects", "nasal dryness" and "epistaxis"). The investigators were unable to find any existing research that examined the days following HFNO use and specifically looked for minor side effects) The investigators have had anecdotal feedback from patients that they tend to experience respiratory symptoms post HFNO. THe investigators would like to determine how often this occurs and how long it lasts for which would be pertinent to consent, and informing patients prior to the procedure, and also serve to improve the literature on this up and coming technique.
Brief Summary The purpose of this study is to investigate how circulating metabolites mediate changes in heart function after exercise intervention. Condition or disease :Cardiovascular function Intervention/treatment Cardiovascular: Echocardiography Other: Vascular Stiffness Other: Metabolomics (Blood)
An early mobilization (EM) program will be implemented in the Cardiovascular Intensive Care Unit at the Jewish General Hospital (JGH), an academic tertiary hospital in Montreal, Quebec. The investigators will perform a prospective, pre/post-EM intervention study in adults aged ≥60 years old admitted to the Cardiovascular Intensive Care Unit (CICU) at the JGH. During a 3-month period, the investigators will prospectively enrol patients to the pre-intervention cohort. The EM intervention will then be implemented. During a 12-month period, the investigators will prospectively enrol patients to the intervention cohort. 1 and 12 months following hospital discharge, patients in the pre-intervention and post-intervention cohorts will be contacted by phone by a member of the research team to assess for functional status and quality of life measures. The primary effectiveness outcome will be the mean improvement in level of function (LOF) during CICU admission and at 1 and 12 months. Covariates predicting improvement in LOF ("responsiveness") and ones which do not ("non-responsiveness") will be assessed. The recovery of physical function at 1 month and 6 months as measured by the SF-36 physical component summary score will be assessed. The SF-36 scores of the highest scoring tertile of LOF on hospital discharge will be compared with the lowest scoring tertile. Hospital readmission at 30 days and discharge home vs. healthcare facility will also be compared. For safety, the composite and individual components of the number of falls, injuries, and dislodgements over the total number of attempted mobility activities will be recorded. The results from the intervention cohort will be compared to the pre-intervention cohort for all results.
--> This is a substudy of the main ESTxENDS trial (NCT03589989). Metabolic outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989. Cardiovascular diseases (CVD) are a leading cause of death in cigarette smokers; quitting smoking is associated with reduced CVD. Cigarette smoking increases CVD through complex mechanisms, mostly on an increase in atherosclerosis and the effect appears unrelated to nicotine. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer or electronic cigarette) have become popular with smokers who want to stop smoking. There is currently no evidence that ENDS use affects CVD outcomes. The nicotine contained in the e-liquids from ENDS has cardiovascular effects and the evidence about health effects mostly comes from studies on nicotine replacement therapy (NRT). These studies did not show an increased risk of CVD from NRTs. The ECLAT trial showed no difference in body weight, resting heart rate, or blood pressure between those who used ENDS or not. Two studies evaluated the short-term effects of ENDS on the cardiovascular system. One study suggested impairment in diastolic ventricular function with cigarettes and not with ENDS. Both ENDS and cigarettes increased diastolic blood pressure, potentially mediated through nicotine exposure, but an increased systolic blood pressure was found only in cigarette smokers. Other studies have suggested no changes in blood pressure in daily users of electronic cigarettes up to 1 year with some even a reduction in blood pressure among patients with hypertension. Interventions helping smokers quit have shown that quitting is associated with increased HDL-cholesterol, weight gain, higher blood glucose, and higher diabetes risk. No large randomized trials have tested the effect of ENDS on blood cholesterol and other markers of cardiovascular risk. This study will therefore test the efficacy of ENDS for cigarette smoking cessation, the safety of ENDS on adverse events and the effect of ENDS on health-related outcomes and exposure to inhaled chemicals. For the main ESTxENDS trial (NCT03589989), smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. All participants will be followed over a 24-month period. Measurements of risk factors for cardiovascular diseases will be done at baseline and at 6, 12 and 24 months' follow-up.
The proposal of this study is to verify if it is feasible and effective to offer a home based cardiac rehabilitation program, that includes the components of health education and physical exercises mostly unsupervised and oriented by telephone and to compare the treatment adherence, the effects in the functional capacity, and the control of coronary risk factors in relation to the traditional cardiac rehabilitation offered mostly supervised and center based.
The aim of this study is to evaluate the feasibility and acceptability of the model of delivering CHW-driven home-based comprehensive NCD control services aimed to prevent premature deaths from cardio-vascular diseases, stroke and breast, cervix and oral cancers in the hard-to-reach women.