Atherosclerosis Clinical Trials

Find Atherosclerosis Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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:

• 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.

∙ 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.

Locations
Other Locations
Germany
Novartis Investigative Site
RECRUITING
Nuremberg
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2025-11-28
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 4500
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov