The Effects of Dietary Supplementation Allicor on Patients With Multifocal Atherosclerosis After Peripheral Artery Revascularization Treatment During a Year
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Frequency of clinically significant cardiovascular events
研究概览
简要总结
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 patient's mitochondrial genome.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
A randomized, double-blinded, placebo-controlled trial
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >40 and <75 years
- •A revascularization (including stenting, endarterectomy, artery prosthetic or bypass grafting) is indicated for the patient because of chronic atherosclerotic obliteration of the arteries of the lower extremities and/or common carotid arteries.
- •Patients passed a complex of instrumental and laboratory examinations before revascularization, including X-ray contrast angiography or ultrasound examination of common carotid arteries and arteries of the lower extremities, the ankle-brachial index (ABI) assessment, biochemical analysis of blood included assessment of cholesterol, triglycerides, low density lipoproteins, high density lipoproteins and glucose levels.
- •The possibility of monitoring the patient for 12 months after revascularization, including phone contacts and visits to the clinic after 6 and 12 months.
- •Patient or legal authorized representative capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Repeated revascularization surgery.
- •Trophic ulcers of the lower extremities.
- •Critical and urgent cardiovascular conditions: tissue ischemia stage III-IV, stroke, acute coronary syndrome, myocardial infarction, chronic heart failure III and IV class NYHA (New York Heart Association).
- •Other critical and urgent conditions not associated with cardiovascular diseases, including the need for urgent interventions, chronic renal failure stages IV-V (creatinine clearance < 30 ml / min according to the Cockcroft-Gault Equation)
- •High degree of disability of the patient (4 or higher points on the modified Rankin scale).
- •History of systemic autoimmune diseases.
- •Significant weight loss (> 10% of body weight in the previous year) of unknown etiology.
- •Conditions that limit adherence to participation in the study (dementia, neuropsychiatric diseases, drug addiction, alcoholism, etc.).
- •Participation in other clinical studies (or use of investigational substances) within 3 months prior to study entry.
- •Patients with malignant tumors, including the postoperative period with chemotherapy and/or radiation therapy.
- •Carriers of HIV or viral hepatitis
- •Pregnancy or breast feeding
- •Refusal to participate in the study.
研究组 & 干预措施
Placebo
Placebo capsule manufactured to mimic Allicor 150 mg capsule by mouth two times a day during the year
干预措施: Placebo (Drug)
Experimental: Allicor
Dietary Supplement: Allicor 150 mg capsule by mouth two times a day during the year
干预措施: Allicor (Dietary Supplement)
结局指标
主要结局
Frequency of clinically significant cardiovascular events
时间窗: Evaluated in 12 months from revascularization interventions
Clinically significant cardiovascular events include: acute myocardial infarction and acute coronary syndrome, acute cerebrovascular accident, progressive heart failure, hospitalization due to critical limb ischemia.
Frequency of indications for a second revascularization
时间窗: Evaluated in 12 months from revascularization interventions
Frequency of second revascularization events during the year.
Frequency of fatal cardiovascular events
时间窗: Evaluated in 12 months from revascularization interventions
Fatal cardiovascular events include: death from myocardial infarction, other forms of coronary heart disease (CHD), stroke, including sudden death and death within 24 hours of symptom onset, death from other non-coronary cardiovascular diseases except definitely non-atherosclerotic causes of death.
次要结局
- Change in the degree of stenosis of the peripheral arteries (lower limbs arteries, common carotid arteries)(Evaluated in 6 and in 12 months from revascularization interventions)
- Variation of intima-media thickness of common carotid arteries(Evaluated in 6 and in 12 months from revascularization interventions)
- Change in the level of cytokine response of monocytes after double stimulation with lipopolysaccharide in in vitro cell culture(Evaluated in 6 and in 12 months from revascularization interventions)
- Changes in the percentage of heteroplasmy of the mitochondrial genome of blood leukocytes in variants associated with atherosclerosis(Evaluated in 6 and in 12 months from revascularization interventions.)
- Change in the ankle-brachial index (ABI)(Evaluated in 6 and in 12 months from revascularization interventions.)
- The maximal walking distance (MWD)(Evaluated in 6 and in 12 months from revascularization interventions)