View clinical trials related to Peripheral Vascular Diseases.
Filter by:Peripheral arterial disease (PAD) is a manifestation of systemic atherosclerotic cardiovascular disease (ASCVD) and is associated with increase cardiovascular risk. PAD impairs quality of life due to symptoms of claudication, pain at rest or risk of limb loss. All major societies recognize the importance of LDL reduction in patients with PAD. Statin therapy improves cardiovascular end-points in patients with PAD and have been shown to improve symptoms of lower extremity intermittent claudication (pain free walking time), 6-minute walking time, ankle-brachial index (ABI), and endothelial function, while decreasing markers of atherosclerosis. This study aims to demonstrate that in patients with PAD on stable maximal tolerated lipid lowering regimen with a statin, further reduction of LDL with the pro protein converts subtilisin/kexin type 9 (PCSK-9) inhibitor Evolocumab, improves functional status (pain free walking time in particular, but also maximal walking time), lower extremity arterial perfusion and endothelial function (brachial endothelial reactivity).
The aim of the conducted research is to evaluate the protective effect of rivaroxaban (trade name of the Xarelto medicinal product), administered together with acetylsalicylic acid (ASA), in comparison with the effectiveness of using ASA alone, in relation to the distance of claudication and exercise tolerance in patients with PAD over a period of 3 months. At present, COMPASS results show that rivaroxaban vascular dose (2.5 mg twice daily) in combination with ASA (75-100 mg once daily) provides more effective cardiovascular protection (defined as cardiovascular death, vascular, myocardial infarction and stroke) compared to ASA alone. So far, however, no scientific studies have been carried out into account the effect of the drug on the progress of PAD and exercise tolerance in patients.
Exercise training improves walking capacity and regional perfusion in patients with Intermittent Claudication (IC). Endothelial Progenitor Cells (EPCs) and Endothelial Microparticles (EMPs) could play an important role in this process, promoting the healing of the diseased endothelium. The investigators are going to measure EPCs and EMPs in a group of patients with IC and in a control group of healthy individuals before a treadmill test and 2, 24, and 48 hours after the test. Subsequently, a group of IC patients will be randomly assigned to perform a 12-week home-based exercise training program. The investigators expect a significant increase of EMPs and EPCs after acute and chronic physical activity. We expect also a correlation between the increase of EMPs and EPCs and the improvement in walking capacity. Aim of the study is to demonstrate that acutely performed aerobic exercise could be able to promote the mobilization of EMPs and EPCs in patients with IC and that endothelial progenitor cells mobilization could play a pivotal role in exercise induced improvement of walking performance and endothelial function in subjects with IC.
The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the Solaris Vascular Stent Graft (Scitech) in clinical settings when used according to the indications of the IFU.
This study evaluates the pain score numerical rating, after sciatic analgesic continuous block, in patients with ischemic pain before surgery of limb revascularization. All patients received those blocks to control ischemic severe pain.
The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study is particularly interested in understanding the effect of the intervention to improve quality of palliative care for patients with Alzheimer's disease and related dementias (ADRD) but will also include other common chronic, life-limiting illnesses. The specific aims are: 1. To evaluate the efficacy of the Survey-based Patient/Clinician Jumpstart compared to the EHR based clinician Jumpstart and usual care for improving quality of care; the primary outcome is EHR documentation of a goals-of-care discussion from randomization through hospitalization or 30 days. Secondary outcomes include: a) intensity of care outcomes (e.g., ICU use, ICU and hospital length of stay, costs of care during the hospitalization, 7 and 30 day readmission); and b) patient- and family-reported outcomes assessed by surveys at 3 days and 4 weeks after randomization, including occurrence and quality of goals-of-care discussions in the hospital, goal-concordant care, psychological symptoms, and quality of life. 2. To conduct a mixed-methods evaluation of the implementation of the intervention, guided by the RE-AIM framework for implementation science, incorporating quantitative evaluation of the intervention's reach and adoption, as well as qualitative analyses of interviews with participants, to explore barriers and facilitators to future implementation and dissemination.
Cardiovascular pathologies (CV), the second leading cause of death just behind tumors, are particularly frequent in France and strongly mobilize the resources of the healthcare system (ambulatory and health facility). The French High Authority for Health (HAS) has defined major cardio-vascular risk factors (CVRF): smoking, high blood pressure (hypertension), elevated total cholesterol (TC) or LDL, decreased HDL cholesterol, type II diabetes and age, and predisposing CVRF or discussed: obesity, sedentary lifestyle, menopause, elevation of triglycerides and genetic factors. Lower-linb peripherial arterial disease (AOMI), even if asymptomatic, involves systemic atherial disease, responsible for mortality irrespective of the presence of CVRF. The prevalence of asymptomatic AOMI is 10 to 20% beyond 55 years old, and the associated mortality is 18 to 30% at 5 years. Individual screening is achievable by well-conducted clinical evaluation and systematic measurement of the simple, non-invasive Blood Pressure Index (BPI) in all subjects at risk. A BPI<0.9 indicates an event risk close to that of the symptomatic patient. However, if this strategy is recommended by the HAS, it is not carried out systematically in current practice. Therapeutic means available for the management of an asymptomatic AOMI are the identification and support for controllable CVRF such as smoking and nutrition (diet and physical activity) in the context of secondary prevention of atherosclerosis. Thus, the generalization of a systematique screening strategy of AOMI, allowing faster handling of CVRF by advices and Motivational Interviewing (MI), could have a significant impact, both clinically and economically. Patients could also benefit from this support in terms of quality of life both on the physiological dimension (effect of weight loss, correction of disorders of cardiac function, etc.), that on the psychic dimension (well-being of patients, management of disorders anxious). However, few studies have evaluated the benefit of such a strategy in terms of quality-adjusted life years (QALYs),none did it on a cost recovery basis. No such studies have been conducted in France. The feasibility of this project is based on the success of a pilot study conducted in Centre-Val de Loire region (France) in 2013. It showed that the implementation of a strategy of systematic screening of the asymptomatic AOMI based on the measurement of the BPI in high cardiovascular risk patients is feasible in current practice by general practitioners, and could be more efficient than interventions performed in current practice.
The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the peripheral vasculature of the lower limbs.
The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients 55 years or older with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1. To evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion in the period between randomization and 30 days following randomization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 7 and 30-day hospital readmissions. 2. To conduct a mixed-methods evaluation of the implementation of the intervention, guided by the RE-AIM framework for implementation science, incorporating quantitative evaluation of the intervention's reach and adoption, as well as qualitative analyses of interviews with participants, to explore barriers and facilitators to future implementation and dissemination.
Atherosclerosis is a civilization disease, which pathophysiology is based on chronic inflammatory response in the wall of vessels that is caused by increase of pro-inflammatory substances. It is a significant challenge for diagnostics and pharmacology. This disease occurs in over 60% of the population over 70 years old. There are many factors that are responsible for this process including group of the arachidonic acid metabolism products - leukotriens, especially leukotriene E4 (LTE4). The effect of these factors was described as the base of pathology not only cardiovascular diseases but also the base of development of asthma and other allergic diseases. The substance which blocks the activity of these factors - montelukast - is a common method of treatment in asthma. The aim of this project is to investigate the influence of cysteinyl leukotriens receptor antagonists on lower limb arteries reocclusion rate in patients with peripheral artery disease (PAD) after endovascular treatment. During previous years we conducted a prospective study, which helped us evaluating the dynamics of leukotriens and thromboxane levels in patients with PAD, who underwent endovascular treatment - peripheral transluminal angioplasty (PTA). We established for the first time the dependence between the increased level of LTE4 in urine (uLTE4) and restenosis or reocclusion occurrence, which translates to the necessity of further procedures and a decrease in the quality of life. We should ask ourselves a question: Is blocking of cysteinyl leukotriens reaction as proinflammatory and proliferative factors, by the use of receptor CysLT1 antagonists going to decrease the quantity of restenosis and reocclusions after endovascular treatment? Within the project performed in the Angiology Department of Jagiellonian University among the patients suffering from PAD and fulfilling all inclusion criteria, the randomized double-blinded clinical study will be performed. Patients will be assigned to two groups: Treatment Group (which will be receiving cysteinyl leukotriene antagonist (montelukast) in a dose of 10mg/day for 12 months) and Control Group to which placebo will be administered. Among all patients population, at every visit at 1., 3., 6., and 12-month clinical state, ultrasound, hemodynamic parameters, and endothelium imaging will be performed as well as uLTE4 measurements. A comparison of the results between both groups will give us an answer if blocking uLTE4 receptors may become a breakthrough in future atherosclerosis treatment. The mechanisms, which lead to restenosis is still not fully understood, and currently used methods of treatment - antiplatelets, anti-proliferative drugs, and anticoagulants - are not fully effective. Thanks to this research the knowledge about treatment and prevention of atherosclerosis will be increased, which will be connected with future better patient care, especially patients with PAD.