Boosting Lp(a) testing in secondary care clinics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Novartis Investigative Site
  Nuremberg, Germany Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.