Markers of Cardiovascular Risk in Patients With Premature Coronary Artery Disease and Treatment

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of study is to examine the relationship between lipid subfractions, inflammation and structural-functional properties of the arterial wall in patients with premature coronary heart disease, to study genetic polymorphisms that determine lipid subfractions concentration on the functional and morphological properties of the arterial vascular wall in patients with early coronary heart disease, to study the effect of alirocumab and evolocumab on lipid subfractions, inflammation and structural-functional properties of arterial wall in patients with early coronary atherosclerosis and to study the influence of NOS-3 gene expression on the functional and morphological properties of the arterial vascular wall in the same patients. Impaired blood fat metabolism and chronic inflammation are intertwined as possible causes of atherosclerosis. Lipoprotein (a) (Lp (a)) is an important risk factor for coronary heart disease and a prognostic predictor in patients after myocardial infarction, but recent research suggests that subtilisin-kexin convertase type 9 (PCSK9) inhibitors are the only drugs that significantly reduce serum Lp (a) concentration. However, there are no data on the relationship between Lp (a) values and polymorphisms for Lp (a), indicators of inflammation and impaired arterial function, and response to treatment with various PCSK9 inhibitors in patients with early coronary heart disease.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Treatments: Evolocumab

Criteria

Inclusion Criteria:

• at least 6 months after acute coronary syndrome,

• up to 55 years at the time of first acute coronary syndrome

• concentration Lp (a) above 1000 mg / L or Lp (a) above 600 mg / L and LDL above 2.6 mmol / L

• optimally treated risk factors for cardiovascular events according to currently valid guidelines.

Exclusion Criteria:

• Age <18 years or > 65 years,

• documented history of myocardial infarction less than 6 months before enrollment

• secondary dyslipidemia,

• severe renal disease (oGFR <30 ml / min),

• moderate to severe liver disease (elevated transaminases above 3 times the norm, elevated bilirubin above 2 times the norm, elevated creatinine kinase above 3 times the norm),

• acute illness 6 weeks before inclusion in the study,

• history of allergic reaction to any ingredient in the drug,

• pregnancy and lactation,

• life expectancy less than 12 months,

• unwillingness to participate or lack of availability for follow-up