Lipoprotein(a) in Patients With Cardiovascular Disease (CVD)

Study Overview
=================
Brief Summary
-----------------
The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).

Official Title
-----------------
Multi-center Cross-sectional Epidemiological Study to Characterize the Prevalence and Distribution of Lipoprotein(a) Levels Among Patients With Established Cardiovascular Disease

Conditions
-----------------
Cardiovascular Disease and Lipoprotein(a)

Intervention / Treatment
-----------------
* Diagnostic Test: Blood draw for Lp(a)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Established CVD defined as one of the following: History of a myocardial infarction (MI) ≥3 months and ≤10 years before the study visit History of ischemic stroke ≥ 3 months and ≤ 10 years before the study visit Symptomatic PAD (intermitted claudication with ankle-brachial index ≤0.90 and/or lower limb amputation or re-vascularization due to lower limb ischemia Exclusion Criteria: - Patients currently enrolled in clinical studies with investigational drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is a multi-center cross-sectional epidemiological study to estimate the prevalence (%) of patients with elevated Lp(a) in patients with established CVD defined by their medical history. One study visit is planned for data collection. Relevant medical history and laboratory values for LDL-cholesterol (LDL-C) and Lp(a) within a past pre-specified period will be collected retrospectively. In case laboratory data are not available, blood sampling will be performed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cardiovascular disease<br>Patients with established Cardiovascular disease | Diagnostic Test: Blood draw for Lp(a)<br>* Collect sample for Lipoprotein(a) testing<br>* Other names: In case retrospective laboratory data are not available, blood sampling will be performed to analyze Lp(a);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with normal and elevated Lipoprotein(a) (Lp(a)) levels in patients with established Cardiovascular Disease (CVD) | Prevalence of normal and elevated Lp(a) levels in patients with established CVD | At screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipoprotein(a) (Lp(a)) values | Evaluate the median and other relevant statistics describing the distribution of Lp(a) within the normal range and elevated Lp(a) levels | At screening | 
| Lp(a) values by region and country | Evaluate the median and other relevant statistics describing the distribution of Lp(a) by region and country | At screening | 
| Low-density lipoprotein cholesterol (LDL(C)) values (corrected and uncorrected) | Evaluate the median and other relevant statistics describing the distribution of LDL-C (corrected and uncorrected) within the normal range and with elevated Lp(a) levels | At screening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CVD, Lipoprotein (a),