Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-01-13 @ 3:28 PM
Study NCT ID:
NCT07267312
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2025-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Premature Coronary Artery Disease and Familial Dyslipidemia in Patients Presenting With Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2025-11-25', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyslipidemia pattern in patients with acute coronary syndrome', 'timeFrame': 'Within 24 hours of hospital admission', 'description': 'Dyslipidemia pattern in patients with acute coronary syndrome was recorded.'}, {'measure': 'Incidence of familial dyslipidemia among patients with acute coronary syndrome', 'timeFrame': 'Within 24 hours of hospital admission', 'description': 'Incidence of familial dyslipidemia among patients with acute coronary syndrome was recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature', 'Coronary Artery Disease', 'Familial Dyslipidemia', 'Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'This study aimed to explore the relationship between familial hypercholesterolemia and premature coronary artery disease, particularly in the context of acute coronary syndrome, by reviewing current evidence and highlighting the need for improved screening and aggressive lipid-lowering strategies in high-risk populations.', 'detailedDescription': 'Dyslipidaemia and familial hypercholesterolemia (FH) are a common disorder that causes premature coronary artery disease.\n\nThe lifelong burden of elevated low-density lipoprotein cholesterol (LDL-C) in FH accelerates endothelial dysfunction and plaque formation, often culminating in acute coronary syndrome (ACS) at a young age. ACS in patients with undiagnosed FH may be their first clinical manifestation, underscoring the importance of early identification and intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a prospective, cross-sectional, observational study conducted at the Department of Cardiology, Prince Khaled Ben Sultan, between December 2021 and March 2025. A total of 2,000 consecutive adult patients admitted with a confirmed diagnosis of coronary artery disease (CAD) were included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years at the time of presentation.\n* Both sexes.\n* Confirmed diagnosis of coronary artery disease (CAD), established by clinical presentation, electrocardiographic findings, elevated cardiac biomarkers, and/or angiographic evidence of ≥50% luminal stenosis in at least one major coronary artery.\n* Hospital admission to the participating cardiology department between \\[insert study period, e.g., January 2020 and December 2024\\] for acute coronary syndrome (ACS), including unstable angina, non-ST-elevation myocardial infarction (NSTEMI), or ST-elevation myocardial infarction (STEMI).\n* Availability of complete clinical, laboratory, and echocardiographic data necessary for classification and analysis.\n\nExclusion Criteria:\n\n* Incomplete medical records or missing essential laboratory, imaging, or demographic data.\n* Secondary causes of dyslipidemia, including uncontrolled hypothyroidism, nephrotic syndrome, chronic liver disease, or use of lipid-altering medications (other than statins) before presentation.\n* Previous congenital or structural heart disease, cardiomyopathy, or significant valvular heart disease unrelated to CAD.\n* Severe chronic kidney disease (estimated glomerular filtration rate \\<30 mL/min/1.73 m²) or patients on dialysis.\n* Autoimmune, inflammatory, or systemic diseases known to influence vascular inflammation or lipid metabolism.\n* Malignancy or life expectancy \\<6 months due to non-cardiac causes.\n* Pregnant or lactating women.\n* Non-Saudi patients (focusing on Saudi population in southern region).'}, 'identificationModule': {'nctId': 'NCT07267312', 'briefTitle': 'Premature Coronary Artery Disease and Familial Dyslipidemia in Patients Presenting With Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Premature Coronary Artery Disease and Familial Dyslipidemia in Patients Presenting With Acute Coronary Syndrome: A Tertiary Cardiac Center Registry', 'orgStudyIdInfo': {'id': 'AFHSRMREC/2023/CARDIOLOGY/678'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-premature coronary artery disease', 'description': 'Males aged \\<55 years and females aged \\<65 years.', 'interventionNames': ['Other: Cardiovascular risk assessment']}, {'label': 'Premature coronary artery disease', 'description': 'Males aged ≥55 years and females aged ≥65 years.', 'interventionNames': ['Other: Cardiovascular risk assessment']}], 'interventions': [{'name': 'Cardiovascular risk assessment', 'type': 'OTHER', 'description': 'Participants underwent a standardized cardiovascular risk assessment that included detailed clinical evaluation, lipid profiling (Total Cholesterol, Low-Density Lipoprotein Cholesterol, High-Density Lipoprotein Cholesterol, and Triglycerides).', 'armGroupLabels': ['Non-premature coronary artery disease', 'Premature coronary artery disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiovascular Medicine Department, Cairo University, Cairo, Egypt.', 'investigatorFullName': 'Mohamed Hassan Senara', 'investigatorAffiliation': 'Cairo University'}}}}