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

April 16, 2023 updated by: Institute for Atherosclerosis Research, Russia

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 121609
        • Recruiting
        • Institute for Atherosclerosis Research
        • Contact:
        • Sub-Investigator:
          • Alexander N Orekhov, PhD, DSc
        • Sub-Investigator:
          • Nikita G Nikiforov, BSc
        • Principal Investigator:
          • Mikhail A Popov, PhD, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age >40 and <75 years
  2. Patients with coronary arteries atherosclerosis for whom coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) is indicated
  3. 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.
  4. The possibility of monitoring the patient for 12 months after revascularization, including phone contacts and visits to the clinic after 6 and 12 months.
  5. 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:

  1. Repeated revascularization surgery.
  2. 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).
  3. 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)
  4. High degree of disability of the patient (4 or higher points on the modified Rankin scale).
  5. History of systemic autoimmune diseases.
  6. Significant weight loss (> 10% of body weight in the previous year) of unknown etiology.
  7. Conditions that limit adherence to participation in the study (dementia, neuropsychiatric diseases, drug addiction, alcoholism, etc.).
  8. Participation in other clinical studies (or use of investigational substances) within 3 months prior to study entry.
  9. Patients with malignant tumors, including the postoperative period with chemotherapy and / or radiation therapy.
  10. Carriers of HIV or viral hepatitis
  11. Pregnancy or breast feeding
  12. Refusal to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
Other Names:
  • 150 mg capsules of dried 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
Other Names:
  • Allicor immitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of fatal cardiovascular events
Time Frame: 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.
Evaluated in 12 months from revascularisation interventions
Frequency of clinically significant cardiovascular events
Time Frame: 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
Evaluated in 12 months from revascularisation interventions
Frequency of indications for a second revascularization
Time Frame: Evaluated in 12 months from revascularisation interventions
Evaluated in 12 months from revascularisation interventions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the degree of stenosis of the coronary arteries
Time Frame: Evaluated in 6 and in 12 months from revascularisation interventions
According to angiography examination
Evaluated in 6 and in 12 months from revascularisation interventions
B-mode ultrasound of carotid arteries
Time Frame: Evaluated in 6 and in 12 months from revascularisation interventions
Variation of intima-media thickness of common carotid arteries
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
Time Frame: 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.
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
Time Frame: 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.
Evaluated in 6 and in 12 months from revascularisation interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Atherosclerosis Research, Russia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

March 31, 2025

Study Registration Dates

First Submitted

March 26, 2023

First Submitted That Met QC Criteria

March 26, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAR-AL-CAR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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