Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-01-16 @ 9:58 AM
Study NCT ID:
NCT03887520
Status:
COMPLETED
Last Update Posted:
2022-01-28
First Post:
2019-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lipoprotein(a) in Patients With Cardiovascular Disease (CVD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a multi-center cross-sectional epidemiological study to estimate the prevalence (%) of patients with elevated Lp(a) in patients with established CVD defined by their medical history. One study visit is planned for data collection. Relevant medical history and laboratory values for LDL-cholesterol (LDL-C) and Lp(a) within a past pre-specified period will be collected retrospectively. In case laboratory data are not available, blood sampling will be performed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49001}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2019-03-21', 'studyFirstSubmitQcDate': '2019-03-21', 'lastUpdatePostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with normal and elevated Lipoprotein(a) (Lp(a)) levels in patients with established Cardiovascular Disease (CVD)', 'timeFrame': 'At screening', 'description': 'Prevalence of normal and elevated Lp(a) levels in patients with established CVD'}], 'secondaryOutcomes': [{'measure': 'Lipoprotein(a) (Lp(a)) values', 'timeFrame': 'At screening', 'description': 'Evaluate the median and other relevant statistics describing the distribution of Lp(a) within the normal range and elevated Lp(a) levels'}, {'measure': 'Lp(a) values by region and country', 'timeFrame': 'At screening', 'description': 'Evaluate the median and other relevant statistics describing the distribution of Lp(a) by region and country'}, {'measure': 'Low-density lipoprotein cholesterol (LDL(C)) values (corrected and uncorrected)', 'timeFrame': 'At screening', 'description': 'Evaluate the median and other relevant statistics describing the distribution of LDL-C (corrected and uncorrected) within the normal range and with elevated Lp(a) levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CVD, Lipoprotein (a),'], 'conditions': ['Cardiovascular Disease and Lipoprotein(a)']}, 'descriptionModule': {'briefSummary': 'The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Established CVD defined as one of the following:\n\n * History of a myocardial infarction (MI) ≥3 months and ≤10 years before the study visit\n * History of ischemic stroke ≥ 3 months and ≤ 10 years before the study visit\n * Symptomatic PAD (intermitted claudication with ankle-brachial index ≤0.90 and/or lower limb amputation or re-vascularization due to lower limb ischemia\n\nExclusion Criteria:\n\n\\- Patients currently enrolled in clinical studies with investigational drugs'}, 'identificationModule': {'nctId': 'NCT03887520', 'briefTitle': 'Lipoprotein(a) in Patients With Cardiovascular Disease (CVD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Multi-center Cross-sectional Epidemiological Study to Characterize the Prevalence and Distribution of Lipoprotein(a) Levels Among Patients With Established Cardiovascular Disease', 'orgStudyIdInfo': {'id': 'CTQJ230A12001'}, 'secondaryIdInfos': [{'id': '2018-003786-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cardiovascular disease', 'description': 'Patients with established Cardiovascular disease', 'interventionNames': ['Diagnostic Test: Blood draw for Lp(a)']}], 'interventions': [{'name': 'Blood draw for Lp(a)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['In case retrospective laboratory data are not available, blood sampling will be performed to analyze Lp(a)'], 'description': 'Collect sample for Lipoprotein(a) testing', 'armGroupLabels': ['Cardiovascular disease']}]}, 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