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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline group | all eligible patients included during the 12 months before the implementation of the strategies. | ||
| 0-12 months group | all eligible patients included in the study during the first 12 months of the implementation of the strategies. | ||
| 13-24 months group | all eligible patients included in the study between 13-24 months after the implementation of the strategies. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with at least one Lp(a) test prescribed at 12 months post-Implementation Strategy (IStr) vs 12 months pre-IStr | 12 months pre-IStr, 12 months post IStr |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with at least one Lp(a) test prescribed at 6 and 12 months post-IStr compared to 12 months pre-IStr | 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 |
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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:
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:
Over 18 years of age and qualify for Lp(a) testing according to local practice.
Exclusion Criteria:
Exclusion criteria at center cluster-level includes:
Electronic records will not be assessed for:
1. Patients that have undergone Lp(a) testing prior to index date (for the post-index assessment)
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cardiology centers (or equivalent) with low or inconsistent Lp(a) testing in Germany, Italy and the UK
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Nuremberg | 90443 | Germany |
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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) |
| 12 months pre-IStr, 12 months post IStr |
| Proportion of tested patients with elevated Lp(a) before and after the implementation of IStr | Proportion of tested patients with elevated Lp(a) ≥50, ≥70, ≥90, ≥180 mg/dL or ≥125, ≥150, ≥190, ≥396 nmol/dL | 12 months pre-IStr, 12 months post-IStr |
| Proportion of HCPs indicating feasibility, appropriateness, and acceptability of interventions post-IStr vs pre-IStr | 6 and 12 months post-IStr |