Baylor Scott & White Medical Center in Temple has opened enrollment on a study designed to help characterize the prevalence and distribution of lipoprotein(a) Lp(a), levels among patients with established cardiovascular disease (CVD).
Given Lp(a) levels have been found to be associated with the risk of developing atherosclerosis, and in turn, the onset of conditions such as heart attacks, stroke or peripheral artery disease, this study will aim to gather data at a global level. The Temple facility will help lead efforts to capture a portion of the target 45,000 participants.
The purpose of this study is to improve knowledge about the epidemiology of Lp(a), with primary and second outcomes measures as follows:
- Percentage of patients with normal and elevated Lp(a) levels in patients with established CVD at screening
- Evaluate the median and other relevant statistics describing the distribution of Lp(a) within the normal range and elevated Lp(a) levels
- Evaluate the median and other relevant statistics describing the distribution of Lp(a) by region and country
- 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
- Signed informed consent
- Established CVD defined as one of
- 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
- Patients currently enrolled in clinical studies with investigational drugs
For a complete list of eligibility criteria and outcomes measures, visit ClinicalTrials.gov. (Study NCT#: NCT03887520).