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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Lp(a) testing is available in this center and reimbursed.
. Capacity to increase Lp(a) testing in relevant patient groups (according to the defined patient eligibility criteria).
. Low and/or inconsistent Lp(a) testing rate(number of eligible patients tested for Lp(a)/number of eligible patients seen) \<15%.
. Willingness to fulfill research requirements, e.g., repurposing existing clinic data for research etc.
. Seeing a defined number of eligible patients per year based on the sample size required for the study.
. Availability of local infrastructure and data interoperability.
. ICF and/or ICF waiver will be sought prior to abstraction of electronic patient records.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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).