PrematureNCT07267312
Premature Coronary Artery Disease and Familial Dyslipidemia in Patients Presenting With Acute Coronary Syndrome
An observational study of Premature and Coronary Artery Disease, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Premature, Coronary Artery Disease, Familial Dyslipidemia
- What is being tested?
- Cardiovascular risk assessment
- How many people
- 2,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 27 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Premature Coronary Artery Disease and Familial Dyslipidemia in Patients Presenting With Acute Coronary Syndrome: A Tertiary Cardiac Center Registry
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.
Read the 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.
- Being tested
- Cardiovascular risk assessment
- Medical subject headings
- Premature Birth, Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular risk assessmentOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Non-premature coronary artery disease | Males aged <55 years and females aged <65 years. Receives: Other: Cardiovascular risk assessment | |
| Premature coronary artery disease | Males aged ≥55 years and females aged ≥65 years. Receives: Other: Cardiovascular risk assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyslipidemia pattern in patients with acute coronary syndrome
Dyslipidemia pattern in patients with acute coronary syndrome was recorded.
Measured: 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.
Measured: Within 24 hours of hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Dec 2021
- Primary completion27 Mar 2025
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hassan Senara, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267312
- Sponsor's protocol ID
- AFHSRMREC/2023/CARDIOLOGY/678
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premature Coronary Artery Disease and Familial Dyslipidemia in Patients Presenting With Acute Coronary Syndrome: A Tertiary Cardiac Center Registry
- ClinicalTrials.gov ID
- NCT07267312
- Acronym / sponsor ID
- AFHSRMREC/2023/CARDIOLOGY/678
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-premature coronary artery disease | – | Other: Cardiovascular risk assessmentMales aged <55 years and females aged <65 years. |
| Premature coronary artery disease | – | Other: Cardiovascular risk assessmentMales aged ≥55 years and females aged ≥65 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular risk assessmentParticipants 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). | Other | Non-premature coronary artery disease, Premature coronary artery disease |
Primary outcome
Dyslipidemia pattern in patients with acute coronary syndrome
Time frame: Within 24 hours of hospital admission
Dyslipidemia pattern in patients with acute coronary syndrome was recorded.
Incidence of familial dyslipidemia among patients with acute coronary syndrome
Time frame: Within 24 hours of hospital admission
Incidence of familial dyslipidemia among patients with acute coronary syndrome was recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature and Coronary Artery Disease, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyslipidemia pattern in patients with acute coronary syndrome (time frame: Within 24 hours of hospital admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.