TEA-CART: The Effects of Allicor on Patients After Coronary Arteria Revascularization Treatment

Sponsor

Institute for Atherosclerosis Research, Russia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05803759

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Ischemia Coronary Artery Bypass Grafting Coronary Arteriosclerosis Percutaneous Coronary Revascularization	Dietary Supplement: Allicor Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

The Effects of Dietary Supplementation Allicor on the Effectiveness of Treatment of Patients After Coronary Arteria Revascularization

Anticipated Study Start Date :

Mar 31, 2023

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Allicor Dietary Supplement: Allicor 150 mg capsule by mouth two times a day	Dietary Supplement: Allicor Each capsule contains 150 mg dried garlic powder
Placebo Comparator: Placebo Placebo capsule manufactured to mimic Allicor 150 mg capsule by by mouth two times a day	Drug: Placebo Capsules manufactured to mimic Allicor 150 mg capsules

Arm

Intervention/Treatment

Active Comparator: Allicor

Dietary Supplement: Allicor 150 mg capsule by mouth two times a day

Dietary Supplement: Allicor

Each capsule contains 150 mg dried garlic powder

Placebo Comparator: Placebo

Placebo capsule manufactured to mimic Allicor 150 mg capsule by by mouth two times a day

Drug: Placebo

Capsules manufactured to mimic Allicor 150 mg capsules

Outcome Measures

Primary Outcome Measures

Frequency of fatal cardiovascular events [Evaluated in 12 months from revascularisation 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.
Frequency of clinically significant cardiovascular events [Evaluated in 12 months from revascularisation interventions]
Clinically significant cardiovascular events include: acute myocardial infarction and acute coronary syndrome, acute cerebrovascular accident, progressive heart failure
Frequency of indications for a second revascularization [Evaluated in 12 months from revascularisation interventions]

Secondary Outcome Measures

Change in the degree of stenosis of the coronary arteries [Evaluated in 6 and in 12 months from revascularisation interventions]
According to angiography examination
B-mode ultrasound of carotid arteries [Evaluated in 6 and in 12 months from revascularisation interventions]
Variation of intima-media thickness of common carotid arteries
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 revascularisation interventions]
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.
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 revascularisation interventions]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age >40 and <75 years
Patients with coronary arteries atherosclerosis for whom coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) is indicated
Patients passed a complex of instrumental and laboratory examinations before revascularization, including ECG, echocardiography, visualization of coronary vessels by X-ray contrast angiography, or CT, screening for atherosclerotic lesions of large arteries, including common carotid arteries, abdominal segment of the aorta, arteries of the lower extremities, 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.

Exclusion Criteria:

Repeated revascularization surgery.
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.