RecruitingNCT07508007

Impact of Implementation Strategies on Lp(a) Testing in Secondary Care Settings

Lp(a)CCELERATE: Impact of Implementation Strategies on Lp(a) Testing in Secondary Care Settings


Sponsor

Novartis Pharmaceuticals

Enrollment

4,500 participants

Start Date

Nov 28, 2025

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria14

  • 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.
  • \. CV specialists or other HCPs managing and accessing CV risk at their respective centers (cardiology units or equivalent).
  • Electronic records are eligible for assessment in this study if they meet all the following criteria:
  • ICF and/or ICF waiver will be sought prior to abstraction of electronic patient records.
  • 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).
  • Previous Lp(a) testing:
  • Patients with an Lp(a) test recorded before the index date will be included in the baseline assessment, which covers the 12 months prior to the index date.
  • For post-index assessments at 6-, 12- and 24-months after the index date, patients with an Lp(a) test recorded before the index date will be excluded.
  • Over 18 years of age and qualify for Lp(a) testing according to local practice.

Exclusion Criteria4

  • Centers with no access to Lp(a) testing.
  • Centers where Lp(a) testing is not reimbursed.
  • Electronic records will not be assessed for:
  • \. Patients that have undergone Lp(a) testing prior to index date (for the post-index assessment)

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Locations(1)

Novartis Investigative Site

Nuremberg, Germany

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NCT07508007