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The Effect of Lipoprotein (a) on Arterial Stiffness, Endothelial Function and Myocardial Deformation

ConditionsLipoprotein DisorderArterial StiffnessEndothelial Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity of Athens

About this trial

1. Introduction Lipoprotein(a), or Lp(a), is a type of lipoprotein that is structurally similar to LDL (low-density lipoprotein) but carries an additional protein called apolipoprotein (a). 2. Purpose of the Study

The primary purpose of this study is to investigate the effect of Lp(a) levels on arterial stiffness, endothelial function, and left atrial (LA) and left ventricular (LV) deformation over a 12-month follow-up period.

Secondarily, the study will investigate: * a) The incidence of major adverse cardiovascular events (MACE), including cardiovascular death, acute myocardial infarction, and acute stroke. * b) The correlation between MACE incidence and parameters of arterial stiffness, endothelial function, and LA/LV deformation. * c) The levels of oxidative load markers. 3. Materials and Methods This observational study will include adults aged 18-75 years (regardless of gender) who visit the outpatient clinics of the 2nd University Cardiology Clinic at "Attikon" General Hospital. All participants will sign a consent form. A full medical history, clinical examination, and blood collection will be performed to determine levels of Total Cholesterol, LDL-C, HDL-C, triglycerides, and Lp(a) at each visit..

Participants will be divided into three groups:

* Group A: Lp(a) ≥50 mg/dL with Total Cholesterol\<200 mg/dl * Group B : Lp(a) \<50 mg/dL. with Total Cholesterol\>200 mg/dl * Group C (Control): Lp(a) \<50 mg/dL. with Total Cholesterol\<200 mg/dl At each group n ≥ 100 participants are anticipated.

Measurements at baseline, at 6 and at 12 months:

* Arterial Stiffness: Determination of carotid-femoral pulse wave velocity (cf-PWV) using the Complior SP device and 24-hour pulse wave analysis with the Mobil-O-Graph device. * Endothelial Function: Measurement of the endothelial glycocalyx thickness of sublingual capillaries using a Sidestream Dark Field (SDF) camera (GlycoCheck). This is expressed through the perfused boundary region (PBR) index. * Cardiac Deformation: Use of two-dimensional strain (speckle tracking) to calculate the Global Longitudinal Strain (GLS) of the LV and LA strain. * Oxidative Load: Determination of malondialdehyde (MDA) and protein carbonyls (PCs) levels as markers of oxidative stress using spectrophotometric kits.

Statistical Analysis: Comparisons regarding the changes in these markers over 6 and 12 months will be conducted between the three groups.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults participants 18-75 years old

Willing to sign the informed consent and paerticipate in the study

Disqualifiers

History of autoimmune/autoinflammatory disease,

Severe valvular heart disease,

severe chronic kidney disease(eGFR<60 ml/min/1.73 m2),

Active Pregnancy

Trial population

This observational study will include adults aged 18-75 years (regardless of gender) who visit the outpatient clinics of the 2nd University Cardiology Clinic at "Attikon" General Hospital. All participants will sign a consent form. A full medical history, clinical examination, and blood collection will be performed to determine levels of Total Cholesterol, LDL-C, HDL-C, triglycerides, and Lp(a) at each visit. Participants will be divided into three groups: * Group A: Lp(a) ≥50 mg/dL with Total Cholesterol\<200 mg/dl * Group B : Lp(a) \<50 mg/dL. with Total Cholesterol\>200 mg/dl * Group C (Control): Lp(a) \<50 mg/dL. with Total Cholesterol\<200 mg/dl At each group n ≥ 100 participants are anticipated.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 3 trial groups
Group A: Participants with elevated Lipoprotein a
Group B: Participants with elevated Total Cholesterol
Group C: Participants with normal lipids levels

Trial outcomes

Primary outcomes

1

Comparison of endothelial glycocalyx thickness difference between groups

Comparison of Perfused Boundary Region (PBR) difference of sublingual vessels between groups

Time frame
12 months
2

Comparison of arterial stiffness difference between groups

Comparison of carotid-to-femoral Pulse Wave Velocity (PWV) difference between groups

Time frame
12 months
3

Comparison of left atrial deformation difference between groups

Comparison of left atrial strain difference between groups

Time frame
12 months
4

Comparison of left ventricular deformation difference between groups

Comparison of left ventricular strain difference between groups

Time frame
12 months

Secondary outcomes

1

Comparison of oxidative stress burden difference between groups

Comparison of malondialdehyde difference between groups

Time frame
12 monnths
2

Comparison of major adverse cardiovascular events between groups

Comparison of the compoite outcome (consisted of : Myocardial Infarction ,stroke, Cardiovascular death) between groups

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Athens

Lead sponsor

Source ClinicalTrials.gov
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