Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-03 @ 1:18 PM
Study NCT ID:
NCT06610669
Status:
RECRUITING
Last Update Posted:
2024-09-24
First Post:
2024-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prevalence of Hyper-Lp(a)-Emia in the PMMHRI-Lp(a) Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2024-09-20', 'studyFirstSubmitQcDate': '2024-09-23', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of hyper-Lp(a)-aemia among the Polish population, along with the identification of associated patient characteristics and risk factors', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lipoprotein(a)'], 'conditions': ['Lipoprotein(a), Hyper-Lp(a)-Emia']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* measured lipoprotein(a) concentration\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06610669', 'briefTitle': 'The Prevalence of Hyper-Lp(a)-Emia in the PMMHRI-Lp(a) Registry', 'organization': {'class': 'OTHER', 'fullName': 'Polish Mother Memorial Hospital Research Institute'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'PMMHRI-Lp(a)-Registry'}}, 'contactsLocationsModule': {'locations': [{'zip': '93-338', 'city': 'Lodz', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA', 'role': 'CONTACT', 'email': 'maciej.banach@icloud.com'}], 'facility': 'Polish Mother Memorial Research Institute', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'centralContacts': [{'name': 'Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA', 'role': 'CONTACT', 'email': 'maciej.banach@icloud.com', 'phone': '+48 42 2711599'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Polish Mother Memorial Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}