Status:
RECRUITING
Evaluating the Impact of 'Tertinat' on Patients with Atherosclerosis-Related Cardiovascular Diseases
Lead Sponsor:
Institute for Atherosclerosis Research, Russia
Conditions:
Atherosclerosis
Atheroscleroses, Coronary
Eligibility:
All Genders
45-75 years
Phase:
PHASE2
Brief Summary
The aim of this clinical trial is to evaluate whether the biologically active food supplement, Tertinat, can influence atherosclerosis progression in adults and improve the treatment outcomes of cardi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
556 Patients enrolled
Trial Details
Trial ID
NCT06590012
Start Date
August 29 2024
End Date
March 1 2026
Last Update
September 19 2024
Active Locations (1)
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1
Institute for Atherosclerosis Research
Moscow, Russia, 121609