The Effects of Allicor on Patients After Revascularization Treatment During a Year

• Status: Not yet recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

Summary

A valuable problem of medical care is atherosclerotic occlusion of peripheral arteries such as lower extremities and brachycephalic arteries, which can eventually lead to loss of limbs or fatal ischemic strokes. Revascularizing surgical interventions can restore the lumen of the arteries and they are an effective way to treat such patients. However up to a third of patients need re-intervention, or suffering cardiovascular complications within a year after surgery. The purpose of our study is to evaluate the effect of the additional to the conventional treatment intake the natural dietary supplement Allicor on the incidence of cardiovascular complications and the effectiveness of treatment after 12 months after the revascularization. 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute for Atherosclerosis Research, Russia

Criteria

Inclusion Criteria:

1. Age >40 and <75 years

2. A revascularization (including stenting, endarterectomy, artery prosthetic or bypass grafting) is indicated for the patient because of chronic atherosclerotic obliteration of the arteries of the lower extremities and/or common carotid arteries.

3. Patients passed a complex of instrumental and laboratory examinations before revascularization, including X-ray contrast angiography or ultrasound examination of common carotid arteries and arteries of the lower extremities, the ankle-brachial index (ABI) assessment, 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. Trophic ulcers of the lower extremities.

3. 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).

4. 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)

5. High degree of disability of the patient (4 or higher points on the modified Rankin scale).

6. History of systemic autoimmune diseases.

7. Significant weight loss (> 10% of body weight in the previous year) of unknown etiology.

8. Conditions that limit adherence to participation in the study (dementia, neuropsychiatric diseases, drug addiction, alcoholism, etc.).

9. Participation in other clinical studies (or use of investigational substances) within 3 months prior to study entry.

10. Patients with malignant tumors, including the postoperative period with chemotherapy and/or radiation therapy.

11. Carriers of HIV or viral hepatitis

12. Pregnancy or breast feeding

13. Refusal to participate in the study.