Lipoprotein(a), Hyper-Lp(a)-EmiaNCT06610669
The Prevalence of Hyper-Lp(a)-Emia in the PMMHRI-Lp(a) Registry
An observational study of Lipoprotein(a), Hyper-Lp(a)-Emia, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lipoprotein(a), Hyper-Lp(a)-Emia
- How many people
- 2,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2022to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- measured lipoprotein(a) concentration
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Polish Mother Memorial Research Institute
Lodz, 93-338
Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA, maciej.banach@icloud.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Lipoprotein(a), Hyper-Lp(a)-Emia
- Keywords
- lipoprotein(a)
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hyper-Lp(a)-aemia among the Polish population, along with the identification of associated patient characteristics and risk factors
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Jan 2022
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipoprotein(a), Hyper-Lp(a)-EmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polish Mother Memorial Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610669
- Sponsor's protocol ID
- PMMHRI-Lp(a)-Registry
- Status last verified
- Aug 2024
- First submitted
- 20 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06610669
- Acronym / sponsor ID
- PMMHRI-Lp(a)-Registry
- Conditions
- Lipoprotein(a), Hyper-Lp(a)-Emia
- Keywords
- lipoprotein(a)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Polish Mother Memorial Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- measured lipoprotein(a) concentration
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
Related trials for Lipoprotein(a), Hyper-Lp(a)-Emia
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Lipoprotein(a), Lipoprotein(a), Hyper-Lp(a)-Emia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipoprotein(a), Hyper-Lp(a)-Emia, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA (+48 42 2711599, maciej.banach@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.