Boosting Lp(a) testing in secondary care clinics

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

This project will try different ways to increase Lp(a) blood testing for adults who attend hospital heart clinics so more people with high Lp(a) are found.

Quick facts

• Study type: Observational
• Enrollment: 4500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Locations: 1 site (Nuremberg)
• Trial ID: NCT07508007 on ClinicalTrials.gov

What this trial studies

This is an observational, cluster-based implementation project that tests whether targeted implementation strategies increase routine Lp(a) testing in secondary-care cardiology settings. Participating centers are selected for low baseline Lp(a) testing rates and must have the infrastructure to repurpose clinic data and support the study. The study will track the proportion of eligible patients who receive Lp(a) testing and use health-care professional surveys to document barriers and facilitators to uptake. Findings will guide how to better implement guideline-recommended Lp(a) measurement in routine practice.

Who should consider this trial

Good fit: Adults seen in participating secondary-care cardiovascular clinics who are eligible for guideline-recommended Lp(a) testing and have not yet been tested are the focus of this work.

Not a fit: Patients who already have documented Lp(a) results, those not seen in participating centers, or whose care would remain unchanged by an Lp(a) result may not directly benefit.

Why it matters

Potential benefit: If successful, more adults with elevated Lp(a) could be identified earlier and offered appropriate cardiovascular risk management.

How similar studies have performed: Other implementation projects have improved uptake of guideline-recommended tests and practices, but applying these strategies specifically to Lp(a) testing is relatively new with limited direct evidence.

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:

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.

Exclusion Criteria:

Exclusion criteria at center cluster-level includes:

1. Centers with no access to Lp(a) testing.
2. 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)

Where this trial is running

Nuremberg

• Novartis Investigative Site — Nuremberg, Germany (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Implementing EAS/ESC Guideline Recommendation on Lp Testing in Routine Practice; Lp; Lipoprotein; Secondary Care Settings; implementation science; Lp test