Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-02-01 @ 7:02 AM
Study NCT ID:
NCT05503095
Status:
UNKNOWN
Last Update Posted:
2023-10-27
First Post:
2022-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PCSK9 Polymorphism and Risk of Cardiac Rupture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006342', 'term': 'Heart Rupture, Post-Infarction'}, {'id': 'D006341', 'term': 'Heart Rupture'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005820', 'term': 'Genetic Testing'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-26', 'studyFirstSubmitDate': '2022-08-09', 'studyFirstSubmitQcDate': '2022-08-15', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PCSK9 gene polymorphism', 'timeFrame': 'up to 1 year', 'description': 'PCSK9 gene polymorphism (studied at patient admission and recovery for acute myocardial infarction)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCSK9', 'Cardiac rupture'], 'conditions': ['Post-Infarction Heart Rupture', 'Gene Polymorphism']}, 'descriptionModule': {'briefSummary': "Protein convertase subtilisin/kexin type 9 (PCSK9) plays a regulatory role in cholesterol homeostasis by promoting low-density lipoprotein receptor (LDLr) degradation. Although the vast majority of the studies have focused on the role of PCSK9 in LDLr expression in the liver, an increasing body of evidence suggests that PCSK9 gene is also present in extra-hepatic tissues. A recent publication showed for the first time that PCSK9 is expressed in the ischemic heart and the expression is highest in the zone bordering the infarcted areas. Furthermore, the expression of PCSK9 is maximal early, at 1 week of ischemia.\n\nMechanical complications (or cardiac ruptures) are uncommon but potentially lethal sequelae of acute myocardium infarction (AMI) and are commonly associated with early mortality without appropriate surgical intervention. It's unknown why some patients develop these devasting complications following AMI, while others not. Interestingly, studies have shown that post-infarction cardiac rupture affect the border zone between the ischemic and normal area and occur within the first 3 to 5 days after AMI.\n\nBased on the aforementioned observations, it's likely to assume a relationship between PCSK9 expression and the development of post-AMI cardiac rupture. Therefore, the main purpose of the this project is to study the PCSK9 gene polymorphism and its association with cardiac rupture. Investigators hypothesize that PCSK9 expression/secretion and development of post-AMI cardiac rupture may be a part of the dynamic changes at cellular levels occurring in the ischemic heart of genetically predisposed patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who develop cardiac rupture following acute myocardial infarction (case group) and patients with acute ST-elevation myocardial infarction not complicated by cardiac rupture (control group)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of acute myocardial infarction with ST sopra-elevation (control group)\n* clinical diagnosis of acute myocardial infarction complicated by cardiac rupture\n\nExclusion Criteria:\n\n* absence of coronary artery disease'}, 'identificationModule': {'nctId': 'NCT05503095', 'briefTitle': 'PCSK9 Polymorphism and Risk of Cardiac Rupture', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'PCSK9 Polymorphism and Risk of Mechanical Complications Following Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'IT-VA-237-2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients who develop cardiac rupture following acute myocardial infarction', 'interventionNames': ['Genetic: Genetic analysis for PCSK9 polymorphisms']}, {'label': 'patients with acute ST-elevation myocardial infarction not complicated by cardiac rupture', 'interventionNames': ['Genetic: Genetic analysis for PCSK9 polymorphisms']}], 'interventions': [{'name': 'Genetic analysis for PCSK9 polymorphisms', 'type': 'GENETIC', 'description': 'Determination of PCSK9 gene polymorphism and serum PCSK9 concentration', 'armGroupLabels': ['patients who develop cardiac rupture following acute myocardial infarction', 'patients with acute ST-elevation myocardial infarction not complicated by cardiac rupture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21100', 'city': 'Varese', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Matteo Matteucci, MD', 'role': 'CONTACT', 'email': 'matteomatteucci87@gmail.com', 'phone': '+39 3493556001'}, {'name': 'Matteo Matteucci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Matteo Matteucci', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}