The Prevalence of Hyper-Lp(a)-Emia in the PMMHRI-Lp(a) Registry

September 23, 2024 updated by: Polish Mother Memorial Hospital Research Institute

The Prevalence, Patients' Characteristics, and Hyper-Lp(a)-Emia Risk Factors in the Polish Population. The Polish Mother's Memorial Hospital Research Institute Lipoprotein(a) Registry

The PMMHRI-Lp(a)-Registry is a non-interventional, single-center registry conducted in the Polish Mother's Memorial Hospital Research Institute (PMMHRI). The PMMHRI-Lp(a)-Registry was established in January 2022. Since then, all consecutive patients of the Department of Cardiology and Adult Congenital Heart Diseases, Department of Endocrinology, and outpatient cardiology and endocrinology clinics with the measured Lp(a) concentration have been included.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The PMMHRI-Lp(a)-Registry is a non-interventional, single-center registry conducted in Poland's 2nd largest, supra-regional hospital - the Polish Mother's Memorial Hospital Research Institute (PMMHRI). The PMMHRI-Lp(a)-Registry was established in January 2022. Since then, all consecutive patients of the Departments of Cardiology, Endocrinology, and outpatient cardiology and endocrinology clinics have been included. The indications for Lp(a) measurement in the registry are based on the 2021 Polish Lipid Guidelines and new Polish recommendations on the management of elevated Lp(a) (2024). Lp(a) was determined using Sentinel's Lp(a) Ultra, an Immunoturbidimetric quantitative test (Sentinel, Milan, Italy), and the results are presented in mg/dl.

The following information was collected from the patient's medical records: demographic parameters; relevant comorbidities; concomitant medications including lipid-lowering therapy status, anticoagulation status; smoking status; post hoc calculated cardiovascular risk score; and laboratory parameters including i.e. Lp(a) and lipids profile.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Łódź, Poland, 93-338
        • Recruiting
        • Polish Mother Memorial Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients of the Department of Cardiology and Adult Congenital Heart Diseases, Department of Endocrinology, and outpatient cardiology and endocrinology clinics with the measured Lp(a) concentration.

Description

Inclusion Criteria:

  • measured lipoprotein(a) concentration

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of hyper-Lp(a)-aemia among the Polish population, along with the identification of associated patient characteristics and risk factors
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Polish Mother Memorial Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PMMHRI-Lp(a)-Registry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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