Impact of Implementation Strategies on Lp(a) Testing in Secondary Care Settings (NCT07508007) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Implementation Strategies on Lp(a) Testing in Secondary Care Settings
Germany4,500 participantsStarted 2025-11-28
Plain-language summary
Lipoprotein(a) \[Lp(a)\] is recognised as an independent, non-modifiable genetic risk factor for cardiovascular (CV) disease. Current guidelines from the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) recommend that Lp(a) be measured at least once in every adult's lifetime, however routine Lp(a) testing rates remains infrequent.
The aim of this study is to assess the impact of implementation strategies (IStr) designed to increase the adoption of Lp(a) testing in routine practice, ultimately leading to more individuals being tested in secondary care. This, in turn, is expected to result in the identification and enhanced management of Cardiovascular Disease (CVD) risk patients with elevated Lp(a).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Lp(a) testing is available in this center and reimbursed.
ā. Capacity to increase Lp(a) testing in relevant patient groups (according to the defined patient eligibility criteria).
ā. Low and/or inconsistent Lp(a) testing rate(number of eligible patients tested for Lp(a)/number of eligible patients seen) \<15%.
ā. Willingness to fulfill research requirements, e.g., repurposing existing clinic data for research etc.
ā. Seeing a defined number of eligible patients per year based on the sample size required for the study.
ā. Availability of local infrastructure and data interoperability.
ā. ICF and/or ICF waiver will be sought prior to abstraction of electronic patient records.
ā. Patients attending at least one SOC visit during the pre-defined time intervals (12 months prior to index date and 0-6 months, 7-12 months and 13-24 months post-index).
Exclusion criteria
ā
What they're measuring
1
Proportion of patients with at least one Lp(a) test prescribed at 12 months post-Implementation Strategy (IStr) vs 12 months pre-IStr
Timeframe: 12 months pre-IStr, 12 months post IStr