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

Primary Purpose

Myocardial Ischemia, Coronary Artery Bypass Grafting, Coronary Arteriosclerosis

Status
Recruiting
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Allicor
Placebo
Sponsored by
Institute for Atherosclerosis Research, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Ischemia focused on measuring Inflammation, Allicin, Mitochondrial Genome

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institute for Atherosclerosis ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Allicor

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Frequency 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.
Frequency of clinically significant cardiovascular events
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

Secondary Outcome Measures

Change in the degree of stenosis of the coronary arteries
According to angiography examination
B-mode ultrasound of carotid arteries
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
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
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.

Full Information

First Posted
March 26, 2023
Last Updated
April 16, 2023
Sponsor
Institute for Atherosclerosis Research, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT05803759
Brief Title
The Effects of Allicor on Patients After Coronary Arteria Revascularization Treatment
Acronym
TEA-CART
Official Title
The Effects of Dietary Supplementation Allicor on the Effectiveness of Treatment of Patients After Coronary Arteria Revascularization
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for Atherosclerosis Research, Russia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Coronary Artery Bypass Grafting, Coronary Arteriosclerosis, Percutaneous Coronary Revascularization
Keywords
Inflammation, Allicin, Mitochondrial Genome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Allicor
Arm Type
Active Comparator
Arm Description
Dietary Supplement: Allicor 150 mg capsule by mouth two times a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule manufactured to mimic Allicor 150 mg capsule by by mouth two times a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Allicor
Other Intervention Name(s)
150 mg capsules of dried dried garlic powder
Intervention Description
Each capsule contains 150 mg dried garlic powder
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Allicor immitation
Intervention Description
Capsules manufactured to mimic Allicor 150 mg capsules
Primary Outcome Measure Information:
Title
Frequency of fatal cardiovascular events
Description
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
Title
Frequency of clinically significant cardiovascular events
Description
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
Title
Frequency of indications for a second revascularization
Time Frame
Evaluated in 12 months from revascularisation interventions
Secondary Outcome Measure Information:
Title
Change in the degree of stenosis of the coronary arteries
Description
According to angiography examination
Time Frame
Evaluated in 6 and in 12 months from revascularisation interventions
Title
B-mode ultrasound of carotid arteries
Description
Variation of intima-media thickness of common carotid arteries
Time Frame
Evaluated in 6 and in 12 months from revascularisation interventions
Title
Change in the level of cytokine response of monocytes after double stimulation with lipopolysaccharide in in vitro cell culture
Description
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
Title
Changes in the percentage of heteroplasmy of the mitochondrial genome of blood leukocytes in variants associated with atherosclerosis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikolay Shakhpazyan, PhD; Dr.
Phone
+79168244496
Email
nshakhpazyan@gmail.com
Facility Information:
Facility Name
Institute for Atherosclerosis Research
City
Moscow
ZIP/Postal Code
121609
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Varvara A Orekhova, MD
Phone
+0079629325095
Email
varvaraao@gmail.com
First Name & Middle Initial & Last Name & Degree
Alexander N Orekhov, PhD, DSc
First Name & Middle Initial & Last Name & Degree
Nikita G Nikiforov, BSc
First Name & Middle Initial & Last Name & Degree
Mikhail A Popov, PhD, Dr.

12. IPD Sharing Statement

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The Effects of Allicor on Patients After Coronary Arteria Revascularization Treatment

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