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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07508007
Acronym
Lp(a)CCELERATE
Enrollment
4500
Registered
2026-04-02
Start date
2025-11-28
Completion date
2028-03-31
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implementing EAS/ESC Guideline Recommendation on Lp(a) Testing in Routine Practice

Keywords

Lp(a), Lipoprotein(a), Secondary Care Settings, implementation science, Lp(a) test

Brief 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).

Interventions

None listed

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Each cluster within this study has a set of inclusion criteria. In addition, to be eligible for inclusion in this study, all the following criteria at the cluster-level must be met: Inclusion criteria for centers: 1. Lp(a) testing is available in this center and reimbursed. 2. Capacity to increase Lp(a) testing in relevant patient groups (according to the defined patient eligibility criteria). 3. Low and/or inconsistent Lp(a) testing rate(number of eligible patients tested for Lp(a)/number of eligible patients seen) \<15%. 4. Willingness to fulfill research requirements, e.g., repurposing existing clinic data for research etc. 5. Seeing a defined number of eligible patients per year based on the sample size required for the study. 6. Availability of local infrastructure and data interoperability. Inclusion criteria for HCP survey participants: 1\. 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: 1. ICF and/or ICF waiver will be sought prior to abstraction of electronic patient records. 2. 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). 3. Previous Lp(a) testing: 1. 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. 2. 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. 4. Over 18 years of age and qualify for Lp(a) testing according to local practice.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with at least one Lp(a) test prescribed at 12 months post-Implementation Strategy (IStr) vs 12 months pre-IStr12 months pre-IStr, 12 months post IStr

Secondary

MeasureTime frameDescription
Proportion of patients with at least one Lp(a) test prescribed at 6 and 12 months post-IStr compared to 12 months pre-IStr12 months pre-IStr to 6 months post and 12 months pre-IStr to 24 months post
Change in proportion of patients with at least one Lp(a) test prescribed 12 months post IStr vs 12 months pre-IStr by pre-defined subgroups of interest12 months pre-IStr, 12 months post IStrChange in proportion of patients with at least one Lp(a) test prescribed 12 months post IStr vs 12 months pre-IStr by pre-defined subgroups of interest (including but not limited to high and very high risk , recent MI; recurrent ASCVD; pre-mature ASCVD)
Proportion of tested patients with elevated Lp(a) before and after the implementation of IStr12 months pre-IStr, 12 months post-IStrProportion of tested patients with elevated Lp(a) ≥50, ≥70, ≥90, ≥180 mg/dL or ≥125, ≥150, ≥190, ≥396 nmol/dL
Proportion of HCPs indicating feasibility, appropriateness, and acceptability of interventions post-IStr vs pre-IStr6 and 12 months post-IStr

Countries

Germany

Contacts

CONTACTNovartis Pharmaceuticals
novartis.email@novartis.com+41613241111
STUDY_DIRECTORNovartis Pharmaceuticals

Novartis Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026