Active clinical trials for "Vascular Diseases"

The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal balloon angioplasty (PTA).

Background: Peripheral arterial disease is a result of atherosclerotic occlusion in the major arteries supplying the lower limbs and is associated with an increased risk of mortality and morbidity. It results in restricted blood flow to the skeletal muscles causing intermittent claudication (IC). IC presents as cramp like pain affecting 5% of the population >50 years and is associated with a substantial reduction in walking capacity, quality of life and diminished physical function. Supervised exercise programmes have been demonstrated to improve maximum walking distances and NICE recommends group-based supervised exercise for treating patients with IC. However, there is significant variability in the impact of treatment across studies and little agreement on the underlying mechanism whereby exercise increases functional outcomes. Potential mechanisms include skeletal muscle metabolism, VO2 max, anaerobic threshold and endothelial function. Studies are needed to better understand how exercise improves outcome and in whom, so as to better refine and target the treatment. The participation of patients with IC in exercise programmes is low. The investigators need to understand factors influencing participation so that we can improve the number of patients with IC benefiting from the programme The research consists of two workstreams: Workstream one Objective: Assess the extent to which patient baseline characteristics and candidate physiological mechanisms are associated with clinical improvement in IC patients participating in an exercise programme Patients: Patients with documented IC referred from a Vascular Consultant. Eligible patients will be invited to participate in a 12 week supervised exercise programme. Testing Schedule: Measurements will be recorded at baseline (prior to exercise), immediately after the completion of the exercise programme and then three months after. Measurements include: Baseline characteristics that might predict outcome: Quality of life using the VascuQol questionnaire Clinical indicators of lower limb function: Ankle brachial pressure index (ABPI), intermittent claudication distance (ICD), Maximum walking distance (MWD). Candidate physiological mechanisms Aerobic capacity (VO2 max & AT) Muscular strength and endurance Muscle morphology (including muscle thickness, pennation angle, fascicle length and elastography) Endothelial function (sheer stress response as measured by flow mediated dilation) Analysis: Regression analysis will be used to explain variation in patient maximum walking distance at 3 months. The regression will use 9 candidate measures of physiological response and 3 baseline measures to explore what mechanism and patient factors may be associated with clinical improvements. 100 patients recruited over 2 years will give a 90% power to detect an additional increase in variability in MWD explained by each candidate measure of around 5% at the a 0.05 significance level. This research will be used to identify which types of exercise may be most influential in improving outcome and in which patients. Workstream two Objective: Explore the reasons behind patients' participation, non-participation in, experience of and adherence to the exercise programme. Study Design: An interview study of patients with IC routinely referred for supervised exercise. Three groups of patients will be invited to participate. Those who: Choose not to participate in the exercise programme (Group A) Agree to participate in the exercise programme (Group B). Agree to participate but discontinue after at least one session (Group C). Semi-structured face-to-face interviews with 20 patients per group, interviews will be conducted using a topic guide to ensure consistency. The format will be flexible to allow participants to generate naturalistic data on what they consider as important and / or successful in terms of outcome. Data will be analysed thematically and managed using Nvivo software - the approach will be inductive and iterative. This research will be used to redesign the current exercise programme to improve participation and so the impact of exercise in patients with IC.

This is the second part of a research study in order to determine if using a specialized pulse oximetry probe with external heat pack will help obtain oxygen saturation (SaO2) and heart rate (HR) during monitoring for patients with peripheral vascular disease (PVD), vasoconstriction, and hypothermic extremities. The inability to obtain accurate SaO2 and pulse readings can lead to misdiagnosis, incorrect treatment, or procedures to be canceled. SaO2 and pulse readings are important to maintain patient stability during diagnostic testing, surgical procedures and monitoring while in critical care areas. Changes in SaO2 and pulse are important to monitor in order to be able to compensate for any decrease in patient oxygen saturations during hemodynamic monitoring. The primary aim of this study is to determine if using a specialized pulse oximetry probe with external heat pack will improve oxygenation readings in order to obtain SaO2 and pulse readings in patients with PVD, vasoconstriction, and hypothermic extremities as compared to readings obtained from an arterial blood gas. The hypothesis is using a specialized pulse oximetry probe with external heat pack will help obtain more accurate pulse oximetry readings consistent with values obtained with an arterial blood gas.

BIOFLEX-I EU is the European arm of the BIOFLEX-I IDE study (NCT01319812). Data from BIOFLEX-I EU will be pooled with data in the IDE. The objective of this study is to separately demonstrate the clinical performance of BIOTRONIK's Astron and Pulsar-18 stents in the European arm of the BIOFLEX-I IDE (NCT01319812). The Pulsar-18 stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.

VIP is a demonstration project with a goal to decrease modifiable risk factors for those with a higher risk of having a vascular event such as a heart attack or stroke or of developing vascular disease. Introduced as a study, VIP compares whether there is a significant reduction of modifiable vascular risk factors among patients who are involved in a personalized directed program versus those being provided standard care by their physician. Health care providers work collaboratively with the 'VIP Team' to improve the participants' vascular health.

The particular aim of this study is the comparison of the diagnostic results of MRA images upon application of Vasovist (gadofosveset), a contrast agent not yet available on the market, with the MRA images upon application of a conventional extracellular contrast agent. A catheter angiography, which will be performed as a routine diagnostic procedure for vascular diseases, will serve as an evaluation standard.

This is the first clinical research trial in which intravenous Prostaglandin E1 (PGE1 is a vasoactive hormone) will be used as supportive treatment along with the angioplasty procedure to treat or open up a blocked artery within one lower limb or the most affected of two limbs in subjects with Peripheral Arterial Occlusive Disease.

The muscles of the leg require a regular supply of oxygen and nutrients. This is supplied by blood carried by a network of large blood vessels known as arteries. Gradually, these arteries can become narrowed or blocked by a build-up of fatty deposits. This process is known as atherosclerosis and leads to a condition called peripheral arterial disease. The restriction of blood flow caused by the blockage prevents exercising muscles getting enough oxygen and nutrients. In some people, this may lead to a painful ache in their legs when they walk, known as intermittent claudication. If the leg pain is severe, surgeons may decide to bypass this blockage using a vein taken from another part of the body, thereby improving blood flow to the foot. Patients with a narrowing or blockage anywhere in the main artery that runs from the groin to the back of the knee may be treated with a particular type of bypass graft known as a femoral-popliteal bypass graft. However, this graft may collapse if not enough blood is flowing through it. This study is looking to see whether a circulation booster machine, known as the REVITIVE® device, can improve the amount of blood flowing through femoral-popliteal bypass grafts. Patients with these grafts attending their usual clinic appointment in the Vascular Outpatients department at Charing Cross Hospital, London will be asked to have their leg scanned using an ultrasound machine to measure the amount of blood flowing through the graft. They will then use the REVITIVE® device for 30 minutes, before being re-scanned to see whether the device has improved blood flow. Improvements in blood flow may suggest a promising role for the device in keeping these grafts open, therefore helping them last longer and potentially reducing the leg pain associated with peripheral arterial disease.

Hypothesis 1: Treatment of heart transplant recipients with sildenafil, a PDE-5 inhibitor, will improve small artery elasticity (SAE) when compared to placebo. Hypothesis 2: PDE-5 inhibition will improve endothelial function, resulting in increased production of nitric oxide, reduced activation of circulating endothelial cells, and increased endothelial progenitor cells.

A qualitative study conducted in 2018 Exploring socio-cultural factors impacting adherence to type 2 diabetes therapy in rural Sargodha featured respondents who were primarily doctors, patients, and. Diet, exercise, and smoking were all variables. The void we investigators will fill will be comprised of several professionals assessing sleep and sedentary lifestyle. A book on anthropology published in 2021 shows the gap are still the same about sedentary life style. The investigators aim to determine lifestyle practices in relation to sedentary behaviour in different occupations & comparing which profession is prone to chronic diseases in accordance to lifestyle practices