Evaluating the Impact of 'Tertinat' on Patients with Atherosclerosis-Related Cardiovascular Diseases

Launched by INSTITUTE FOR ATHEROSCLEROSIS RESEARCH, RUSSIA · Sep 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a dietary supplement called Tertinat to see if it can help slow down the progression of atherosclerosis, a condition that affects the arteries and can lead to serious heart problems. Researchers want to find out if taking Tertinat can reduce the number of major heart-related events, such as heart attacks and strokes, in adults with cardiovascular diseases caused by atherosclerosis. Participants will either take Tertinat or a placebo (a harmless sugar pill) every day for two years and will visit the clinic once a year for check-ups and tests.

To be eligible for this study, participants should be adults with specific cardiovascular conditions related to atherosclerosis who require medical treatment. They need to have undergone necessary medical tests to assess their heart health and should be able to return for annual follow-ups. It's important to note that people with severe heart issues or other serious health conditions may not qualify. Throughout the trial, participants will receive their regular medical care while also taking Tertinat or the placebo.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with cardiovascular disease disease of atherosclerotic origin, requiring hospitalization and treatment hospital conditions. Cardiovascular diseases may include the following nosology: Coronary heart disease; Atherosclerosis. Diseases include (and/or) atherosclerotic lesions of the coronary arteries, brachiocephalic arteries, limb arteries, renal arteries requiring surgical revascularization.
• • Patients who have undergone a complex of necessary by current standards for their disease instrumental and laboratory examinations, including ECG, severity assessment vascular stenosis (ultrasound, CT, angiography), including large arteries, brachiocephalic arteries, femoral arteries, biochemical blood test assessing the level of general cholesterol, triglycerides, lipoproteins low density, high lipoprotein density, glucose level.
• • Possibility of monitoring the patient - Possibility every 12 months call the patient for questioning and examination.
• • The patient has signed informed consent.
• Exclusion Criteria:
• • 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)
• • Systemic autoimmune diseases in medical history, including: rheumatoid arthritis, systemic lupus erythematosus, autoimmune thyroiditis, autoimmune vasculitis, ulcerative colitis.
• • 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.
• • Carriers of HIV or viral hepatitis
• • Pregnancy or breast feeding
• • Refusal to participate in the study.