NCT07267312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

3.3 years

First QC Date

November 25, 2025

Last Update Submit

November 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Dyslipidemia pattern in patients with acute coronary syndrome

    Dyslipidemia pattern in patients with acute coronary syndrome was recorded.

    Within 24 hours of hospital admission

  • Incidence of familial dyslipidemia among patients with acute coronary syndrome

    Incidence of familial dyslipidemia among patients with acute coronary syndrome was recorded.

    Within 24 hours of hospital admission

Study Arms (2)

Non-premature coronary artery disease

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

Other: Cardiovascular risk assessment

Premature coronary artery disease

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

Other: Cardiovascular risk assessment

Interventions

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).

Non-premature coronary artery diseasePremature coronary artery disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Premature BirthCoronary Artery DiseaseAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiovascular Medicine Department, Cairo University, Cairo, Egypt.

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 5, 2025

Study Start

December 1, 2021

Primary Completion

March 27, 2025

Study Completion

March 27, 2025

Last Updated

December 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations