Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-01-04 @ 4:38 PM
Study NCT ID:
NCT06450561
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2024-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adherence to Secondary Prevention Guidelines for Cardiovascular Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2024-06-03', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patients admitted for a cardiovascular event who are prescribed lipid-lowering treatment at discharge', 'timeFrame': 'Up to 3 months', 'description': 'Proportion of patients admitted for a cardiovascular event, warranting the initiation of secondary prevention with lipid-lowering agents, who are prescribed lipid-lowering treatment at discharge, adequate to reduce LDL by 50% or to below 55 mg/dL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atherosclerosis', 'Stroke, Ischemic', 'Acute Coronary Syndrome', 'Ischemic Heart Disease', 'Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'The present observational study aims to determine the degree of adherence to the recommendations of clinical guidelines regarding the prevention of cardiovascular complications in patients hospitalized due to a cardiovascular event.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized due to a cardiovascular event', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to the cardiology, neurology, or general surgery departments\n* With any of the following admission diagnoses:\n\nNon-ST-segment elevation acute coronary syndrome (NSTEACS) ST-segment elevation acute coronary syndrome (STEACS) Stable angina Unstable angina Non-ST-segment elevation myocardial infarction (NSTEMI) ST-segment elevation myocardial infarction (STEMI) Atherothrombotic ischemic stroke Lacunar stroke Peripheral artery disease Chronic ischemia of lower limbs Vascular ulcer due to arterial cause\n\nExclusion Criteria:\n\n* Patients for whom lipid-lowering treatment is ruled out due to limited life expectancy\n* Patients likely to die during hospitalization\n* Patients who died during hospitalization'}, 'identificationModule': {'nctId': 'NCT06450561', 'briefTitle': 'Adherence to Secondary Prevention Guidelines for Cardiovascular Risk', 'organization': {'class': 'OTHER', 'fullName': "Consorci Sanitari de l'Alt Penedès i Garraf"}, 'officialTitle': 'Adherence to Secondary Prevention Guidelines for Cardiovascular Risk', 'orgStudyIdInfo': {'id': 'CSAPG-60'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients hospitalized due to a cardiovascular event', 'description': 'Patients hospitalized due to a cardiovascular event including stroke, acute coronary syndrome, ischemic heart disease, or peripheral arterial disease', 'interventionNames': ['Other: cardiovascular event']}], 'interventions': [{'name': 'cardiovascular event', 'type': 'OTHER', 'description': 'In this single group observational trial the exposure of interest is a cardiovascular event.', 'armGroupLabels': ['Patients hospitalized due to a cardiovascular event']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08810', 'city': 'Sant Pere de Ribes', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Sanitari Alt Penedes i Garraf-Hospital Sant Camil', 'geoPoint': {'lat': 41.26045, 'lon': 1.77391}}], 'overallOfficials': [{'name': 'Lidia Tikhomirova', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CSAPG'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After publication of main results of the study.', 'ipdSharing': 'YES', 'description': 'IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).', 'accessCriteria': 'IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Consorci Sanitari de l'Alt Penedès i Garraf", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}