Premature Coronary Artery Disease and Familial Dyslipidemia in Patients Presenting With Acute Coronary Syndrome

NCT ID: NCT07267312

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-03-27

Brief Summary

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.

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.

Conditions

Premature; Coronary Artery Disease; Familial Dyslipidemia; Acute Coronary Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Non-premature coronary artery disease

Males aged \<55 years and females aged \<65 years.

Cardiovascular risk assessment

Intervention Type: OTHER

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).

Premature coronary artery disease

Males aged ≥55 years and females aged ≥65 years.

Cardiovascular risk assessment

Intervention Type: OTHER

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).

Interventions

Cardiovascular risk assessment

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).

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Hassan Senara

Cardiovascular Medicine Department, Cairo University, Cairo, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

AFHSRMREC/2023/CARDIOLOGY/678

Identifier Type: -

Identifier Source: org_study_id