Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05813171
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-19
First Post:
2023-04-02
Brief Title:
The Effects of Allicor on Patients After Revascularization Treatment During a Year
Sponsor:
Institute for Atherosclerosis Research Russia
Organization:
Institute for Atherosclerosis Research Russia
Study Overview
Official Title:
The Effects of Dietary Supplementation Allicor on Patients With Multifocal Atherosclerosis After Peripheral Artery Revascularization Treatment During a Year
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEA-PARTY
Brief Summary:
A significant challenge in medical care is atherosclerotic occlusion of peripheral arteries such as lower extremities and brachiocephalic arteries which can eventually lead to loss of limbs or fatal ischemic strokes Revascularizing surgical interventions can restore the lumen of the arteries and provide an effective way to treat such patients However up to a third of patients need re-intervention or experience cardiovascular complications within a year after surgery The purpose of this study is to evaluate the effect of adding the natural dietary supplement Allicor to conventional treatment on the incidence of cardiovascular complications and treatment effectiveness 12 months after revascularization Another valuable area of investigation is the search for predictors of long-term cardiovascular complications after revascularization which could be markers of inflammation and heteroplasmy levels in the patients mitochondrial genome
Detailed Description:
Recently atherosclerosis of large arteries has become a common problem affecting the quality of life and life expectancy of the population In addition to atherosclerosis of coronary arteries leading to myocardial ischemia another significant issue is atherosclerosis of the lower limb and brachiocephalic arteries Typically arteries are affected in multiple areas resulting in multifocal atherosclerosis of several arterial basins Consequently 14 to 19 of patients suffering from damage to the arteries of the lower extremities have significant stenosis of the common carotid arteries Clinical guidelines from the European Society of Cardiology ESC and the European Society for Vascular Surgery ESVS emphasize the need to examine other arteries in patients with atherosclerosis of the arteries of the lower extremities Clinical screening for carotid and subclavian artery stenosis is also recommended
The surgical method for treating arterial occlusive lesions includes revascularization interventions to restore blood flow thus eliminating tissue ischemia and preventing fatal and disabling consequences In addition to surgical treatment medications that lower blood cholesterol and reduce blood thrombogenesis are used
An important predictor of disease and treatment efficiency is the level of systemic inflammatory markers such as protein-C An anti-inflammatory approach is not used for treating patients with multifocal atherosclerosis However investigating new markers of inflammation may be promising for the development of new diagnostics
Insofar as up to a third of patients face the need for re-intervention or suffer cardiovascular complications within a year after revascularization surgery the search for new approaches to treat multifocal arterial atherosclerosis is necessary
Long-term use of drugs of natural origin with anti-inflammatory and anti-atherosclerotic effects may be promising
Dietary Supplementation Allicor consists of dried garlic There is a trial study ClinicalTrialsgov Identifier NCT01734707 that determined the ability of Allicor to have a beneficial effect on patients with atherosclerosis and there are also data on the beneficial effect of Allicor on the condition of patients with coronary heart disease Another randomized double-blind placebo-controlled trial of a dietary supplement made of garlic ClinicalTrialsgov Identifier NCT03860350 found benefits for patients with coronary artery atherosclerosis Thus there is reason to believe that Allicor will improve treatment outcomes in patients with multifocal atherosclerosis
The aim of this study is to investigate how the addition of Allicor to the standard treatment affects the incidence of serious cardiovascular events during a year after revascularization intervention Also to be assessed is the need for repeated operations as well as an evaluation of arterial flow and arterial wall The study will also assess promising markers related to atherosclerosis and inflammation - an in vitro monocyte cytokine release test and heteroplasmy levels of the patients mitochondrial genome variants associated with atherosclerosis
The surgical method for treating arterial occlusive lesions includes revascularization interventions to restore blood flow thus eliminating tissue ischemia and preventing fatal and disabling consequences In addition to surgical treatment medications that lower blood cholesterol and reduce blood thrombogenesis are used
An important predictor of disease and treatment efficiency is the level of systemic inflammatory markers such as protein-C An anti-inflammatory approach is not used for treating patients with multifocal atherosclerosis However investigating new markers of inflammation may be promising for the development of new diagnostics
Insofar as up to a third of patients face the need for re-intervention or suffer cardiovascular complications within a year after revascularization surgery the search for new approaches to treat multifocal arterial atherosclerosis is necessary
Long-term use of drugs of natural origin with anti-inflammatory and anti-atherosclerotic effects may be promising
Dietary Supplementation Allicor consists of dried garlic There is a trial study ClinicalTrialsgov Identifier NCT01734707 that determined the ability of Allicor to have a beneficial effect on patients with atherosclerosis and there are also data on the beneficial effect of Allicor on the condition of patients with coronary heart disease Another randomized double-blind placebo-controlled trial of a dietary supplement made of garlic ClinicalTrialsgov Identifier NCT03860350 found benefits for patients with coronary artery atherosclerosis Thus there is reason to believe that Allicor will improve treatment outcomes in patients with multifocal atherosclerosis
The aim of this study is to investigate how the addition of Allicor to the standard treatment affects the incidence of serious cardiovascular events during a year after revascularization intervention Also to be assessed is the need for repeated operations as well as an evaluation of arterial flow and arterial wall The study will also assess promising markers related to atherosclerosis and inflammation - an in vitro monocyte cytokine release test and heteroplasmy levels of the patients mitochondrial genome variants associated with atherosclerosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None