- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07267312
Premature Coronary Artery Disease and Familial Dyslipidemia in Patients Presenting With Acute Coronary Syndrome
Premature Coronary Artery Disease and Familial Dyslipidemia in Patients Presenting With Acute Coronary Syndrome: A Tertiary Cardiac Center Registry
Study Overview
Status
Intervention / Treatment
Detailed Description
Dyslipidaemia and familial hypercholesterolemia (FH) are a common disorder that causes premature coronary artery disease.
The 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 12613
- Cairo University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years at the time of presentation.
- Both sexes.
- 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.
- 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).
- Availability of complete clinical, laboratory, and echocardiographic data necessary for classification and analysis.
Exclusion Criteria:
- Incomplete medical records or missing essential laboratory, imaging, or demographic data.
- Secondary causes of dyslipidemia, including uncontrolled hypothyroidism, nephrotic syndrome, chronic liver disease, or use of lipid-altering medications (other than statins) before presentation.
- Previous congenital or structural heart disease, cardiomyopathy, or significant valvular heart disease unrelated to CAD.
- Severe chronic kidney disease (estimated glomerular filtration rate <30 mL/min/1.73 m²) or patients on dialysis.
- Autoimmune, inflammatory, or systemic diseases known to influence vascular inflammation or lipid metabolism.
- Malignancy or life expectancy <6 months due to non-cardiac causes.
- Pregnant or lactating women.
- Non-Saudi patients (focusing on Saudi population in southern region).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Non-premature coronary artery disease
Males aged <55 years and females aged <65 years.
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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).
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Premature coronary artery disease
Males aged ≥55 years and females aged ≥65 years.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dyslipidemia pattern in patients with acute coronary syndrome
Time Frame: Within 24 hours of hospital admission
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Dyslipidemia pattern in patients with acute coronary syndrome was recorded.
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Within 24 hours of hospital admission
|
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Incidence of familial dyslipidemia among patients with acute coronary syndrome
Time Frame: Within 24 hours of hospital admission
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Incidence of familial dyslipidemia among patients with acute coronary syndrome was recorded.
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Within 24 hours of hospital admission
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Heart Diseases
- Obstetric Labor, Premature
- Obstetric Labor Complications
- Pregnancy Complications
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Myocardial Ischemia
- Premature Birth
- Coronary Artery Disease
- Acute Coronary Syndrome
Other Study ID Numbers
- AFHSRMREC/2023/CARDIOLOGY/678
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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