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Peripheral Artery Disease clinical trials

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NCT ID: NCT06319339 Not yet recruiting - Clinical trials for Peripheral Arterial Disease

Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease

Start date: August 2024
Phase: Early Phase 1
Study type: Interventional

Purpose: Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. Eligibility: Individuals with PAD will be deemed eligible for this study if they 1) are 50-75 years old and postmenopausal, 2) have a positive history of exercise-limiting claudication (Fontaine II or III), 3) do not have renal impairments, 4) do not have Fontaine stage IV PAD, and 5) are not currently pregnant or nursing. Age-matched controls will be deemed eligible for this study if they 1) are 50-75 years old and postmenopausal, 2) have an ABI greater than 0.9 (no PAD), 3) do not have exercise-limiting diseases or injuries, 4) do not have renal impairments, and 5) are not currently pregnant or nursing. Intervention and Evaluation: During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. Follow-up: There will be a follow-up visit to assess blood work after diroximel fumarate.

NCT ID: NCT06318767 Recruiting - Clinical trials for Peripheral Artery Disease

Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage

TAMIS
Start date: March 4, 2024
Phase: N/A
Study type: Interventional

Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades. It has various symptoms ranging from mild arterial claudication to critical limb ischemia. The critical ischaemia stage in PAD is defined by rest pain or trophic disorders and is a special situation because of the number of cardiovascular deaths at 1 year (25%), 60% at 5 years and acute ischaemic recurrence at 1 year (25%). It is a medico-surgical pathology. A haemodynamic marker is needed to monitor patients, as it is predictive of limb progression, cardiovascular events and mortality. The Systolic Rise Time (SRT) of the plantar footpad is a recently described haemodynamic measurement of proven value in the diagnosis of PAD. The aim of this study is to show the prognostic value of the Systolic Rise Time on Major Adverse Limb Events (MALE).

NCT ID: NCT06300450 Recruiting - Clinical trials for Peripheral Artery Disease

Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy

PAD-ALERT
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

This single-center, 400-patient, randomized controlled trial assesses the impact of a patient- and provider-facing EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase guideline-directed utilization of statin and statin-alternative oral LDL-C lowering therapies in patients with PAD who are not being prescribed LDL-C-lowering therapy.

NCT ID: NCT06260488 Not yet recruiting - Clinical trials for Peripheral Artery Disease

Histological Segmentation of the Superficial Femoral Artery From Microscan to CT Using Artificial Intelligence

CTPred
Start date: February 15, 2024
Phase: N/A
Study type: Interventional

The femoropopliteal artery segment (FPAS) is one of the longest arteries in the human body, undergoing torsion, compression, flexion and extension due to lower limb movements. Endovascular surgery is considered to be the treatment of choice for the peripheral arterial disease, the results of which depend on the physiological forces on the arterial wall, the anatomy of the vessels and the characteristics of the lesions being treated. The atheromatous disease includes, in a simple way, 3 categories of plaques: calcified, fibrous, and lipidic. The study of these plaques and their differentiation in imaging and histology in the FPAS has already been the subject of research. To treat them, there are angioplasty balloons and stents with different designs and components, with different mechanical properties and different impregnated molecules. There is no non-invasive method (imaging) to accurately differentiate lesions along the FPAS. The analysis is performed from the preoperative CT scan, but there are high-resolution scanners that allow a quasi-histological analysis of the tissue. This microscanner can be used ex vivo. In the framework of a project, the learning algorithm was be créated (Convolutional Neural Networks) to automatically segment microscanner slices: after taking FPAS from amputated limbs, we correlated ex-vivo microscanner images of the arteries with their histology. The correlation was then performed manually between the microscanner images, and the histological sections obtained. the algorithm well be trained on these slices and validated its performance. The validation of the CT and microscanner concordance was the subject of scientific publications.

NCT ID: NCT06231966 Not yet recruiting - Clinical trials for Peripheral Artery Disease

Randomized Comparison of Efficacy and Safety of High-intensity Rosuvastatin/Ezetimibe Combination Versus Treat-to-target Rosuvastatin Monotherapy for Patients With Peripheral Artery or Polyvascular Disease (CARE-PVD Trial)

Start date: February 2024
Phase: N/A
Study type: Interventional

Patients with atherosclerotic peripheral artery disease often have combined coronary artery disease or cerebral artery disease and show high rates of cardiovascular mortality and morbidities. Therefore, secondary prevention for these patients is of great clinical importance. Currently, Korean, US, and European guidelines recommend different LDL cholesterol target goals in patients with peripheral artery disease. In recent clinical trials, combination therapy of statin plus ezetimibe demonstrated improved cardiovascular outcomes compared with statin monotherapy. Thus, the purpose of the CARE-PVD study is to investigate whether the combination therapy of high intensity rosuvastatin 20 mg plus ezetimibe 10 mg can improve cardiovascular outcomes in patient with peripheral artery disease or polyvascular artery disease in comparison with rosuvastatin treat-to-target (LDL cholesterol <70 mg/dL) monotherapy.

NCT ID: NCT06215248 Not yet recruiting - Heart Failure Clinical Trials

Myocardial Dysfunction Evaluation in Lower Extremity Arterial Disease Patients With Deformation Analysis

MEDAL
Start date: January 2024
Phase:
Study type: Observational

Single centre observational study to assess lower extremity arterial disease (LEAD) patients' cardiac dysfunction with strain analyses and to assess connections between cardiac dysfunction, metabolomic changes and target organ damage in LEAD.

NCT ID: NCT06212271 Not yet recruiting - Clinical trials for Peripheral Artery Disease

A Mechanistic Clinical Trial of Colchicine in Patients Undergoing Femoral Endarterectomy

Start date: March 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this mechanistic clinical trial is to test the effects of reducing inflammatory signaling in femoral artery atherosclerotic plaques. Researchers will compare patients receiving colchicine to patients receiving placebo to determine the effect of colchicine on the inflammatory state of atherosclerotic femoral arteries.

NCT ID: NCT06173960 Completed - Clinical trials for Peripheral Artery Disease

3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions

FIDJI
Start date: November 3, 2023
Phase:
Study type: Observational

The goal of this non interventional study is to evaluate the long-term clinical effects (3-year follow-up after the procedure) of Jetstream atherectomy combined with a paclitaxel-eluting balloon (Ranger) in all patients who were treated for calcified femoropopliteal lesions (de novo, single or multiple, mono- or bilateral) between December 1, 2016 and December 31, 2020 at the Clinique Rhône-Durance, Avignon, France

NCT ID: NCT06165016 Recruiting - Aging Clinical Trials

Far Red Light to Improve Functioning in PAD

LIGHT PAD
Start date: February 14, 2024
Phase: N/A
Study type: Interventional

The LIGHT PAD Trial is a Phase II multi-centered randomized clinical trial to collect preliminary data to test whether daily far red light treatment of the lower extremities in people with PAD improves six-minute walk distance, lower extremity perfusion, and ischemia-related damage in gastrocnemius muscle at four-month follow-up, compared to a sham control. Participants will complete 10 minutes of twice daily home treatment with either far red light or a sham light for four months.

NCT ID: NCT06115213 Recruiting - Hypertension Clinical Trials

The North Kynouria Project

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The North Kynouria Project was initiated to study cardiovascular/stroke risk factors by employing mass screening and long-term surveillance of an adult population in the municipality of North Kynouria, in the county of Arcadia, Peloponnese, Greece. The North Kynouria Study was initiated to assess modifiable and non-modifiable determinants of cerebrovascular and coronary heart disease.