Cardiovascular Disease and Lipoprotein(a)
Conditions
Keywords
CVD, Lipoprotein (a),
Brief summary
The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).
Interventions
DIAGNOSTIC_TESTBlood draw for Lp(a)
Collect sample for Lipoprotein(a) testing
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with normal and elevated Lipoprotein(a) (Lp(a)) levels in patients with established Cardiovascular Disease (CVD) | At screening | Prevalence of normal and elevated Lp(a) levels in patients with established CVD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipoprotein(a) (Lp(a)) values | At screening | Evaluate the median and other relevant statistics describing the distribution of Lp(a) within the normal range and elevated Lp(a) levels |
| Lp(a) values by region and country | At screening | Evaluate the median and other relevant statistics describing the distribution of Lp(a) by region and country |
| Low-density lipoprotein cholesterol (LDL(C)) values (corrected and uncorrected) | At screening | 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 |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Vietnam
Outcome results
None listed