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Recruiting NCT07508007

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Implementing EAS/ESC Guideline Recommendation on Lp(a) Testing in Routine Practice. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Primary outcome measures

  • 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 outcome measures (4)
  • 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]
  • 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]
  • 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 HCPs indicating feasibility, appropriateness, and acceptability of interventions post-IStr vs pre-IStr [Time frame: 6 and 12 months post-IStr]

Eligibility criteria

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:

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:

  • 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:

1\. Patients that have undergone Lp(a) testing prior to index date (for the post-index assessment)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Novartis Investigative Site — Nuremberg

Identifiers

NCT: NCT07508007 · CTQJ230A12012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗