Coronary revascularization interventions such as coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) are the standard of surgical treatment of patients with myocardial ischemia. However, up to 30% of patients experience complications of varying degrees within 12 months after the revascularization, or need for second intervention. Thus, it is necessary to search for additional approaches to the postoperative treatment of patients in order to improve the long-term results of revascularization treatment. Substances of natural origin with an anti-atherosclerotic effect have a good potential. These substances, as dietary supplements, can be taken by patients for a long time in conjunction with other prescribed medicines and treatments. Another valuable direction of investigations is the search for predictors of long-term cardiovascular complications after revascularization, which can be markers of inflammation and heteroplasmy levels of the patient's mitochondrial genome. The purpose of this study is to determine whether the intake of dietary supplement Allicor at a daily dose of 300 mg affects the frequency of long-term postoperative cardiovascular complications and re-intervention in patients after revascularization operations on the coronary arteries. The second goal is assessing the relationship between the grade monocytes inflammatory response and the level of heteroplasmy of the mitochondrial genome of blood leukocytes with the frequency of cardiovascular complications and re-interventions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Institute for Atherosclerosis Research
Moscow, Russia
RECRUITINGFrequency of fatal cardiovascular events
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.
Time frame: Evaluated in 12 months from revascularisation interventions
Frequency of clinically significant cardiovascular events
Clinically significant cardiovascular events include: acute myocardial infarction and acute coronary syndrome, acute cerebrovascular accident, progressive heart failure
Time frame: Evaluated in 12 months from revascularisation interventions
Frequency of indications for a second revascularization
Time frame: Evaluated in 12 months from revascularisation interventions
Change in the degree of stenosis of the coronary arteries
According to angiography examination
Time frame: Evaluated in 6 and in 12 months from revascularisation interventions
B-mode ultrasound of carotid arteries
Variation of intima-media thickness of common carotid arteries
Time frame: Evaluated in 6 and in 12 months from revascularisation interventions
Change in the level of cytokine response of monocytes after double stimulation with lipopolysaccharide in in vitro cell culture
Cytokine level measurement by ELISA (TNF-a; IL-1b; IL-6; IL-8; IL-10; CCL2) after the first and second LPS stimulation of monocytes.
Time frame: Evaluated in 6 and in 12 months from revascularisation interventions
Changes in the percentage of heteroplasmy of the mitochondrial genome of blood leukocytes in variants associated with atherosclerosis
Includes variants m.12315G\>A, m.13513G\>A, m.14459G\>A, m.14846G\>A, m.15059G\>A, m.1555A\>G, m.3256C\>T, m.3336T\>C, m.5178C\>A, m.652delG measured with quantitative PCR.
Time frame: Evaluated in 6 and in 12 months from revascularisation interventions
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