SerumNCT07209631
Serum Lipoprotein-a as a Marker of Severity of Coronary Artery Disease in Aortic Valve Sclerosis Patients
An observational study of Serum and Lipoprotein(A), run by Sohag University at 1 site in Egypt.
Trial summary
This work aimed to evaluate the association of serum level of Lp(a) with the severity of coronary artery disease (CAD) in aortic valve sclerosis (AVS) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serum, Lipoprotein(A), Severity
- What is being tested?
- Serum Lipoprotein-a level
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 May 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 prospective cohort study was carried out on 100 patients. The study was done after approval from the local Ethics Committee (Under the Declaration of Helsinki). Informed written consent was obtained from the patients.
Who may be able to join
- Age ≥ 18 years.
- Both sexes.
- Patients with chest pain and/or dyspnea were diagnosed provisionally as having coronary artery disease.
Who cannot join
- Aortic stenosis.
- Aortic prosthesis.
- Untreated hypothyroidism.
- Severe chronic kidney failure.
- Administration of anti-inflammatory or immunosuppressive drugs.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Lipoprotein-a Just a Lipid Marker or a Predictor for the Severity of Coronary Lesions in Aortic Valve Sclerosis Patients?
This work aimed to evaluate the association of serum level of Lp(a) with the severity of coronary artery disease (CAD) in aortic valve sclerosis (AVS) patients.
Read the detailed description
Aortic valve sclerosis (AVS) has a prevalence of 2% to 7% in the population above 65 years of age. In industrialized countries, aortic valve sclerosis is most frequently caused by progressive calcification and degeneration of the aortic cusps.
Coronary artery disease (CAD) is the most significant single cause of death in the world. In developed countries, more than 25% of all deaths in persons older than 35 years are due to CAD. More than half of acute myocardial infarctions occur without previous history or symptoms of CAD.
In recent years, there has been a special emphasis on lipoprotein(a) (Lp(a)), a significant, causal, and nonmodifiable predictor of valvular outcomes and CAD in the general population
- Conditions
- Serum, Lipoprotein(A), Severity, Coronary Artery Disease, Aortic Valve Sclerosis
- Being tested
- Serum Lipoprotein-a level
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Lipoprotein-a levelOther
A venous blood sample was taken from each patient a month or so after discharge to check their Lp (a) levels. The samples were centrifuged for 10 minutes at 2-8 °C, after which the serum was divided into aliquots and stored at -20 ° C.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with chest pain and/or dyspnea were diagnosed provisionally as having coronary artery disease. Receives: Other: Serum Lipoprotein-a level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of significance of coronary lesions
Incidence of significance of coronary lesions in relation to lipoprotein (a) level was recorded.
Measured: 1 month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Oct 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SerumStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remon Saleh Adly, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209631
- Sponsor's protocol ID
- Soh-Med-24-09-5PD
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 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 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Lipoprotein-a Just a Lipid Marker or a Predictor for the Severity of Coronary Lesions in Aortic Valve Sclerosis Patients?
- ClinicalTrials.gov ID
- NCT07209631
- Acronym / sponsor ID
- Soh-Med-24-09-5PD
- Conditions
- Serum, Lipoprotein(A), Severity, Coronary Artery Disease, Aortic Valve Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 7 Oct 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 work aimed to evaluate the association of serum level of Lp(a) with the severity of coronary artery disease (CAD) in aortic valve sclerosis (AVS) patients.
Detailed description
Aortic valve sclerosis (AVS) has a prevalence of 2% to 7% in the population above 65 years of age. In industrialized countries, aortic valve sclerosis is most frequently caused by progressive calcification and degeneration of the aortic cusps.
Coronary artery disease (CAD) is the most significant single cause of death in the world. In developed countries, more than 25% of all deaths in persons older than 35 years are due to CAD. More than half of acute myocardial infarctions occur without previous history or symptoms of CAD.
In recent years, there has been a special emphasis on lipoprotein(a) (Lp(a)), a significant, causal, and nonmodifiable predictor of valvular outcomes and CAD in the general population
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Serum Lipoprotein-a levelPatients with chest pain and/or dyspnea were diagnosed provisionally as having coronary artery disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective cohort study was carried out on 100 patients. The study was done after approval from the local Ethics Committee (Under the Declaration of Helsinki). Informed written consent was obtained from the patients.
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Both sexes.
- Patients with chest pain and/or dyspnea were diagnosed provisionally as having coronary artery disease.
Key exclusion criteria (6 listed)
- Aortic stenosis.
- Aortic prosthesis.
- Untreated hypothyroidism.
- Severe chronic kidney failure.
- Administration of anti-inflammatory or immunosuppressive drugs.
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 |
|---|---|---|
| Serum Lipoprotein-a levelA venous blood sample was taken from each patient a month or so after discharge to check their Lp (a) levels. The samples were centrifuged for 10 minutes at 2-8 °C, after which the serum was divided into aliquots and stored at -20 ° C. | Other | Study group |
Primary outcome
Incidence of significance of coronary lesions
Time frame: 1 month post-procedure
Incidence of significance of coronary lesions in relation to lipoprotein (a) level 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 7 Oct 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 Serum and Lipoprotein(A), run by Sohag 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 3 inclusion and 6 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 7 Oct 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?
Incidence of significance of coronary lesions (time frame: 1 month post-procedure). 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 7 Oct 2025.