The Effects of Allicor on Patients After Coronary Arteria Revascularization Treatment

Myocardial Ischemia Clinical Trial

— TEA-CART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05803759
• Other study ID #: IAR-AL-CAR
• Status: Recruiting
• Phase: Phase 4
• Start date: April 10, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2023
• Source: Institute for Atherosclerosis Research, Russia
• Contact: Nikolay Shakhpazyan, PhD; Dr.
• Phone: +79168244496
• Email: nshakhpazyan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Bypass Grafting
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia
• Percutaneous Coronary Revascularization

Intervention

Dietary Supplement:
• Allicor
Each capsule contains 150 mg dried garlic powder

Drug:
• Placebo
Capsules manufactured to mimic Allicor 150 mg capsules

Locations

Country	Name	City	State
Russian Federation	Institute for Atherosclerosis Research	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Atherosclerosis Research, Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (16)

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Falk E. Pathogenesis of atherosclerosis. J Am Coll Cardiol. 2006 Apr 18;47(8 Suppl):C7-12. doi: 10.1016/j.jacc.2005.09.068. — View Citation

Gao X, Xue Z, Ma Q, Guo Q, Xing L, Santhanam RK, Zhang M, Chen H. Antioxidant and antihypertensive effects of garlic protein and its hydrolysates and the related mechanism. J Food Biochem. 2020 Feb;44(2):e13126. doi: 10.1111/jfbc.13126. Epub 2019 Dec 26. — View Citation

Hamal S, Cherukuri L, Birudaraju D, Matsumoto S, Kinninger A, Chaganti BT, Flores F, Shaikh K, Roy SK, Budoff MJ. Short-term impact of aged garlic extract on endothelial function in diabetes: A randomized, double-blind, placebo-controlled trial. Exp Ther Med. 2020 Feb;19(2):1485-1489. doi: 10.3892/etm.2019.8377. Epub 2019 Dec 27. — View Citation

Imaizumi VM, Laurindo LF, Manzan B, Guiguer EL, Oshiiwa M, Otoboni AMMB, Araujo AC, Tofano RJ, Barbalho SM. Garlic: A systematic review of the effects on cardiovascular diseases. Crit Rev Food Sci Nutr. 2022 Feb 23:1-23. doi: 10.1080/10408398.2022.2043821. Online ahead of print. — View Citation

Lindstedt S, Wlosinska M, Nilsson AC, Hlebowicz J, Fakhro M, Sheikh R. Successful improved peripheral tissue perfusion was seen in patients with atherosclerosis after 12 months of treatment with aged garlic extract. Int Wound J. 2021 Oct;18(5):681-691. doi: 10.1111/iwj.13570. Epub 2021 Feb 16. — View Citation

Mollahosseini M, Hosseini-Marnani E, Panjeshahin A, Panbehkar-Jouybari M, Gheflati A, Mozaffari-Khosravi H. A systematic review of randomized controlled trials related to the effects of garlic supplementation on platelet aggregation. Phytother Res. 2022 Nov;36(11):4041-4050. doi: 10.1002/ptr.7556. Epub 2022 Oct 12. — View Citation

Orekhov AN, Grunwald J. Effects of garlic on atherosclerosis. Nutrition. 1997 Jul-Aug;13(7-8):656-63. doi: 10.1016/s0899-9007(97)83010-9. — View Citation

Orekhov AN, Sobenin IA, Korneev NV, Kirichenko TV, Myasoedova VA, Melnichenko AA, Balcells M, Edelman ER, Bobryshev YV. Anti-atherosclerotic therapy based on botanicals. Recent Pat Cardiovasc Drug Discov. 2013 Apr;8(1):56-66. doi: 10.2174/18722083113079990008. — View Citation

Orekhov AN, Tertov VV. In vitro effect of garlic powder extract on lipid content in normal and atherosclerotic human aortic cells. Lipids. 1997 Oct;32(10):1055-60. doi: 10.1007/s11745-997-0136-7. — View Citation

Panyod S, Wu WK, Chen PC, Chong KV, Yang YT, Chuang HL, Chen CC, Chen RA, Liu PY, Chung CH, Huang HS, Lin AY, Shen TD, Yang KC, Huang TF, Hsu CC, Ho CT, Kao HL, Orekhov AN, Wu MS, Sheen LY. Atherosclerosis amelioration by allicin in raw garlic through gut microbiota and trimethylamine-N-oxide modulation. NPJ Biofilms Microbiomes. 2022 Jan 27;8(1):4. doi: 10.1038/s41522-022-00266-3. — View Citation

Piragine E, Citi V, Lawson K, Calderone V, Martelli A. Potential Effects of Natural H2S-Donors in Hypertension Management. Biomolecules. 2022 Apr 14;12(4):581. doi: 10.3390/biom12040581. — View Citation

Reinhart KM, Talati R, White CM, Coleman CI. The impact of garlic on lipid parameters: a systematic review and meta-analysis. Nutr Res Rev. 2009 Jun;22(1):39-48. doi: 10.1017/S0954422409350003. — View Citation

Ried K. Garlic lowers blood pressure in hypertensive subjects, improves arterial stiffness and gut microbiota: A review and meta-analysis. Exp Ther Med. 2020 Feb;19(2):1472-1478. doi: 10.3892/etm.2019.8374. Epub 2019 Dec 27. — View Citation

Sobenin IA, Pryanishnikov VV, Kunnova LM, Rabinovich YA, Martirosyan DM, Orekhov AN. The effects of time-released garlic powder tablets on multifunctional cardiovascular risk in patients with coronary artery disease. Lipids Health Dis. 2010 Oct 19;9:119. doi: 10.1186/1476-511X-9-119. — View Citation

Wlosinska M, Nilsson AC, Hlebowicz J, Hauggaard A, Kjellin M, Fakhro M, Lindstedt S. The effect of aged garlic extract on the atherosclerotic process - a randomized double-blind placebo-controlled trial. BMC Complement Med Ther. 2020 Apr 29;20(1):132. doi: 10.1186/s12906-020-02932-5. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Evaluated in 12 months from revascularisation interventions
Primary	Frequency of clinically significant cardiovascular events	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
Primary	Frequency of indications for a second revascularization		Evaluated in 12 months from revascularisation interventions
Secondary	Change in the degree of stenosis of the coronary arteries	According to angiography examination	Evaluated in 6 and in 12 months from revascularisation interventions
Secondary	B-mode ultrasound of carotid arteries	Variation of intima-media thickness of common carotid arteries	Evaluated in 6 and in 12 months from revascularisation interventions
Secondary	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.	Evaluated in 6 and in 12 months from revascularisation interventions
Secondary	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.	Evaluated in 6 and in 12 months from revascularisation interventions