UnknownNot Applicable

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

Slovenia70 participantsStarted 2020-11-10

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ultrasound functional and morphological properties of the arterial wall and Lp (a) concentration

Timeframe: Baseline

Concentration of Lp (a) and SNP in the LPA gene

Timeframe: Baseline

The effect of alirocumab or evolocumab on functional and morphological properties of arterial wall after 6 months

Timeframe: 6 months

Trial details

NCT IDNCT04613167

SponsorUniversity Medical Centre Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-30

Contact for this trial

Miran Šebeštjen, prof.

+38615228541 miran.sebestjen@guest.arnes.si, miran.sebestjen@kclj.si

View on ClinicalTrials.gov More Acute Coronary Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Ultrasound functional and morphological properties of the arterial wall and Lp (a) concentration

Timeframe: Baseline

Concentration of Lp (a) and SNP in the LPA gene

Timeframe: Baseline

The effect of alirocumab or evolocumab on functional and morphological properties of arterial wall after 6 months

Timeframe: 6 months