Peripheral Arterial Disease Clinical Trial
Official title:
Effect of Dark Chocolate on Endothelial Function and Oxidative Stress in Patients With Peripheral Vascular Disease.
Peripheral arterial disease (PAD) is a clinical setting characterized by an exceptionally
high risk for cardiovascular events. Oxidative stress seems to play a role in impairing
flow-mediated dilation (FMD) and contributing to atherosclerosis in patients with PAD. Cocoa
seems to exert artery dilatation via oxidative stress inhibition.
OBJECTIVES: To investigate whether in PAD patients, dark chocolate elicits artery dilatation
via down-regulation of NOX2, the catalytic core of NADPH oxidase.
Atherosclerosis represents the major cause of worldwide death; it is a complex phenomenon
that encompasses the intricate interplay of classic cardiovascular risk factors, oxidative
stress and inflammation.
Peripheral artery disease (PAD) is a clinical setting that well represents the model of
widespread atherosclerosis. PAD affects 20% of patients over the age of 75. Furthermore, PAD
patients are at an exceptionally high risk for cardiovascular events and the majority will
eventually die of a cardiac or cerebrovascular etiology.
Polyphenol could represent a novel therapeutic strategy to counteract atherosclerosis.
During the last decades, a growing interest in polyphenols resulted from prospective and
epidemiological studies that showed the beneficial effects of these substances on human
health. In particular, polyphenols exert their beneficial effect by inhibition of NADPH
oxidase (NOX2), an enzyme directly involved in atherosclerosis; thus, the activation of this
enzyme leads to an enhanced production of oxidative stress and inflammatory processes.
The objective of this study is to evaluate the effect of polyphenols on oxidative stress and
inflammation and on surrogate markers of atherosclerosis in PAD patients. Polyphenols,
inhibiting NOX2-mediated oxidative stress and immune-mediated process, could represent a
novel therapy to reduce the high risk of cardiovascular events in PAD.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
Active, not recruiting |
NCT03987061 -
MOTIV Bioresorbable Scaffold in BTK 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 | |
Active, not recruiting |
NCT04677725 -
NEtwork to Control ATherothrombosis (NEAT Registry)
|
||
Recruiting |
NCT05961943 -
RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients
|
N/A | |
Recruiting |
NCT06047002 -
Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
|
||
Completed |
NCT03185052 -
Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
|
N/A | |
Recruiting |
NCT05992896 -
A Study of Loco-Regional Liposomal Bupivacaine Injection
|
Phase 4 | |
Completed |
NCT04635501 -
AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial
|
N/A | |
Recruiting |
NCT04584632 -
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
|
N/A | |
Withdrawn |
NCT03994185 -
The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
|
N/A | |
Withdrawn |
NCT03538392 -
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
|
||
Recruiting |
NCT02915796 -
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty
|
Phase 1 | |
Active, not recruiting |
NCT02900924 -
Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
|
||
Completed |
NCT02901847 -
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
|
N/A | |
Not yet recruiting |
NCT02387450 -
Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication
|
Phase 2/Phase 3 | |
Withdrawn |
NCT02126540 -
Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries
|
N/A | |
Not yet recruiting |
NCT02455726 -
Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease
|
N/A | |
Completed |
NCT02022423 -
Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease
|
N/A |