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Coronary Artery Disease (CAD)NCT07184034

Lipoprotein a Assessment and Relation to Ca Score in CAD Patients Using MSCT

An observational study of Coronary Artery Disease (CAD), run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to evaluate whether serum Lipoprotein(a) [Lp(a)] levels are associated with coronary artery calcium (CAC) score measured by multi-slice computed tomography (MSCT) in adults undergoing cardiac risk assessment. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Coronary Artery Disease (CAD)
How many people
150 participants
Where
No sites listed yet
Study dates
Sep 2025to Oct 2026
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will include adult men and women aged 40 to 70 years who are classified as having intermediate cardiovascular risk (10-20% estimated 10-year ASCVD risk). Participants will be those referred for non-contrast multi-slice CT (MSCT) for suspected coronary artery disease and who are able to provide informed consent. Patients will be excluded if they have known coronary artery disease, prior myocardial infarction, prior coronary revascularization, or history of stroke. Additional exclusions include recent use of statins or PCSK9 inhibitors within the past 3 months, renal insufficiency (eGFR <45 mL/min/1.73m²), or active inflammatory or autoimmune disease.

Who may be able to join

  • 1-adults aged 40-70
  • 2- classified as intermediate cardiovascular risk (10-20% 10 years ASCVD risk)
  • 3-undergoing MsCT for suspected coronary artery disease
  • 4- ability to provide informed consent

Who cannot join

  • 1- known CAD or prior revascularization
  • 2-history of myocardial infarction or stroke
  • 3- statin or PCK9 inhibitor use in the past 3 months
  • 4-renal insufficiency (eGFR < 45ml/min/1.73m2)
  • 5-active inflammation or autoimmune disease

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Kerolos Kamel contact

+201282111275

Kerolosayman99@gmail.com

About this study

Official title: Assessment of the Correlation Between Lipoprotein (a) Levels and Coronary Artery Findings on Multislice Computed Tomography

The goal of this observational study is to evaluate whether serum Lipoprotein(a) [Lp(a)] levels are associated with coronary artery calcium (CAC) score measured by multi-slice computed tomography (MSCT) in adults undergoing cardiac risk assessment.

The main questions it aims to answer are:

Read more
  • Is there a correlation between elevated Lp(a) levels and higher CAC scores?
  • Does Lp(a) provide additional predictive value for subclinical atherosclerosis beyond traditional cardiovascular risk factors?

Participants will:

  • Undergo a non-contrast MSCT scan to measure CAC score.
  • Provide a blood sample for measurement of Lp(a) and routine lipid profile.
  • Have baseline clinical and demographic data collected, including cardiovascular risk factors.
Read the detailed description

Lipoprotein(a) [Lp(a)] is a genetically determined lipoprotein particle structurally similar to LDL, with an additional apolipoprotein(a) component. Elevated Lp(a) levels have been identified as an independent and causal risk factor for atherosclerotic cardiovascular disease (ASCVD). The pro-atherogenic, pro-thrombotic, and pro-inflammatory properties of Lp(a) contribute to plaque development and vascular calcification.

Coronary artery calcium (CAC) score, assessed by non-contrast multi-slice computed tomography (MSCT), is a widely validated imaging biomarker of subclinical coronary atherosclerosis. CAC burden strongly predicts future cardiovascular events and is frequently used for individualized risk stratification. Recent studies suggest that individuals with elevated Lp(a) may also demonstrate higher CAC scores and faster progression of coronary calcification. However, the strength and consistency of this association remain insufficiently defined across different populations.

This observational study is designed to evaluate the correlation between serum Lp(a) levels and CAC score in adult participants undergoing cardiovascular risk assessment. Participants will undergo non-contrast MSCT scanning for CAC scoring, fasting blood sampling for Lp(a) and routine lipid profile, and collection of baseline demographic and clinical risk factors. Multivariable analyses will assess the independent relationship between Lp(a) and CAC score, as well as the potential incremental predictive value of Lp(a) beyond traditional risk factors such as LDL-C, hypertension, diabetes, and smoking.

We hypothesize that higher Lp(a) levels will be associated with higher CAC scores, independent of conventional cardiovascular risk factors, and that patients with both elevated Lp(a) and high CAC (≥100) will represent the subgroup at greatest risk for ASCVD. Demonstrating this relationship may improve cardiovascular risk stratification and highlight the importance of integrating Lp(a) measurement with imaging-based assessment in the early prevention of ASCVD.

Medical subject headings
Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between serum lipoprotein (a) levels and coronary artery calcium (CAC) score as measured by MSCT.

    Measured: Baseline

Secondary outcomes (1)

  1. Check which of these patients will need revascularization after 6 to 12 months

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionSep 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

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
150 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07184034
Sponsor's protocol ID
Lipoprotein a assessment
Status last verified
Sep 2025
First submitted
13 Sep 2025
Last updated
19 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zeitouni M, Nanna MG, Sun JL, Chiswell K, Peterson ED, Navar AM. Performance of Guideline Recommendations for Prevention of Myocardial Infarction in Young Adults. J Am Coll Cardiol. 2020 Aug 11;76(6):653-664. doi: 10.1016/j.jacc.2020.06.030.

    PubMed 32762899

  • Kobayashi R, Kawakatsu S, Morioka D, Suzuki A. Diversity of dopamine transporter images in frontotemporal lobar degeneration-motor neuron disease. Psychogeriatrics. 2022 Sep;22(5):771. doi: 10.1111/psyg.12860. Epub 2022 Jun 5. No abstract available.

    PubMed 35665572

  • Thanassoulis G, Campbell CY, Owens DS, Smith JG, Smith AV, Peloso GM, Kerr KF, Pechlivanis S, Budoff MJ, Harris TB, Malhotra R, O'Brien KD, Kamstrup PR, Nordestgaard BG, Tybjaerg-Hansen A, Allison MA, Aspelund T, Criqui MH, Heckbert SR, Hwang SJ, Liu Y, Sjogren M, van der Pals J, Kalsch H, Muhleisen TW, Nothen MM, Cupples LA, Caslake M, Di Angelantonio E, Danesh J, Rotter JI, Sigurdsson S, Wong Q, Erbel R, Kathiresan S, Melander O, Gudnason V, O'Donnell CJ, Post WS; CHARGE Extracoronary Calcium Working Group. Genetic associations with valvular calcification and aortic stenosis. N Engl J Med. 2013 Feb 7;368(6):503-12. doi: 10.1056/NEJMoa1109034.

    PubMed 23388002

  • Hemmelgarn BR, Manns BJ, Lloyd A, James MT, Klarenbach S, Quinn RR, Wiebe N, Tonelli M; Alberta Kidney Disease Network. Relation between kidney function, proteinuria, and adverse outcomes. JAMA. 2010 Feb 3;303(5):423-9. doi: 10.1001/jama.2010.39.

    PubMed 20124537

  • Kamstrup PR, Benn M, Tybjaerg-Hansen A, Nordestgaard BG. Extreme lipoprotein(a) levels and risk of myocardial infarction in the general population: the Copenhagen City Heart Study. Circulation. 2008 Jan 15;117(2):176-84. doi: 10.1161/CIRCULATIONAHA.107.715698. Epub 2007 Dec 17.

    PubMed 18086931

  • Tsimikas S. A Test in Context: Lipoprotein(a): Diagnosis, Prognosis, Controversies, and Emerging Therapies. J Am Coll Cardiol. 2017 Feb 14;69(6):692-711. doi: 10.1016/j.jacc.2016.11.042.

    PubMed 28183512

  • Budoff MJ, Shaw LJ, Liu ST, Weinstein SR, Mosler TP, Tseng PH, Flores FR, Callister TQ, Raggi P, Berman DS. Long-term prognosis associated with coronary calcification: observations from a registry of 25,253 patients. J Am Coll Cardiol. 2007 May 8;49(18):1860-70. doi: 10.1016/j.jacc.2006.10.079. Epub 2007 Apr 20.

    PubMed 17481445

  • Greenland P, Blaha MJ, Budoff MJ, Erbel R, Watson KE. Coronary Calcium Score and Cardiovascular Risk. J Am Coll Cardiol. 2018 Jul 24;72(4):434-447. doi: 10.1016/j.jacc.2018.05.027.

    PubMed 30025580

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease (CAD), run by Assiut University.

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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kerolos Kamel (+201282111275, Kerolosayman99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between serum lipoprotein (a) levels and coronary artery calcium (CAC) score as measured by MSCT. (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07184034, which also lists 8 linked publications.

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 19 Sep 2025.

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