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NCT Number: NCT07508007

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

Nuremberg, 90443, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

Inclusion criteria

for HCP survey participants:

  • 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 criteria

Exclusion criteria

at center cluster-level includes:

  • 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)

Treatment and study plan

Primary outcomes

  1. Proportion of patients with at least one Lp(a) test prescribed at 12 months post-Implementation Strategy (IStr) vs 12 months pre-IStr

    Time frame: 12 months pre-IStr, 12 months post IStr

Secondary outcomes

  1. Proportion of patients with at least one Lp(a) test prescribed at 6 and 12 months post-IStr compared to 12 months pre-IStr

    Time frame: 12 months pre-IStr to 6 months post and 12 months pre-IStr to 24 months post

  2. 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 interest

    Time frame: 12 months pre-IStr, 12 months post IStr

    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 interest (including but not limited to high and very high risk , recent MI; recurrent ASCVD; pre-mature ASCVD)

  3. Proportion of tested patients with elevated Lp(a) before and after the implementation of IStr

    Time frame: 12 months pre-IStr, 12 months post-IStr

    Proportion of tested patients with elevated Lp(a) ≥50, ≥70, ≥90, ≥180 mg/dL or ≥125, ≥150, ≥190, ≥396 nmol/dL

  4. Proportion of HCPs indicating feasibility, appropriateness, and acceptability of interventions post-IStr vs pre-IStr

    Time frame: 6 and 12 months post-IStr

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: Lp(a)CCELERATE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.