Cardiovascular Biomarkers in Peripheral Artery Disease.

Status Active, not recruiting

Clinical Trial Summary

Despite the best medical management, many patients with peripheral artery disease (PAD) who undergo lower extremity endovascular revascularization experience adverse cardiovascular outcomes and postoperative complications that may increase the risk of acute limb ischemia or amputation. There are no clear molecular associations that could explain the differences in outcomes after endovascular therapy in patients with PAD. The variable outcomes following endovascular therapy may depend, at least in part, on the profile of cytokines involved in inflammatory and atherosclerotic processes. The goal of this observational study is to evaluate the potential use of circulating IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 levels as biomarkers of major adverse limb events (MALE) and major adverse cardiovascular events (MACE) in diabetic patients with PAD and chronic limb-threatening ischemia (CLTI) requiring a procedure of endovascular revascularization. The main questions it aims to answer are: - association between serum levels of IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 at baseline and major adverse limb events (MALE) after lower extremity revascularization. - association between serum levels of IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 at baseline and major adverse cardiovascular events (MACE) after lower extremity revascularization. Diabetic patients with CLTI requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 before the endovascular procedure. Incidence of MALE and MACE will be collected in a 12-months follow-up and will be associated with IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05757258
Study type	Observational
Source	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact
Status	Active, not recruiting
Phase
Start date	October 24, 2019
Completion date	October 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04534257` - Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore	N/A
Recruiting	`NCT04511234` - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease	N/A
Recruiting	`NCT03506633` - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients	N/A
Active, not recruiting	`NCT03506646` - Dietary Nitrate Supplementation and Thermoregulation	N/A
Completed	`NCT02554266` - Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
Completed	`NCT03921905` - Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Not yet recruiting	`NCT06369350` - Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion	Early Phase 1
Not yet recruiting	`NCT05063474` - Microvascular Reactivity in Peripheral Artery Disease
Recruiting	`NCT04545268` - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance	N/A
Recruiting	`NCT02389023` - Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery	N/A
Completed	`NCT02539940` - Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Completed	`NCT02542267` - In-Stent Restenosis Post-Approval Study	N/A
Completed	`NCT02522884` - Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries	N/A
Completed	`NCT02563535` - Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia	Phase 4
Completed	`NCT02228564` - BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease	N/A
Completed	`NCT02145065` - First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)	N/A
Completed	`NCT02262949` - A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System	N/A
Completed	`NCT01743872` - Optical Imaging Measurement of Intravascular Solution Efficacy Trial	N/A
Recruiting	`NCT01424020` - Walking Estimated Limitation Calculated by History - Study 2	Phase 4
Active, not recruiting	`NCT01597453` - NOR-SYS: The Norwegian Stroke in the Young Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.