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

NCT07184034 | Not Yet Recruiting

• 1 other identifier: Lipoprotein a assessment
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. The main questions it aims to answer are:

• 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.

Conditions

Coronary Artery Disease (CAD)

Outcome Measures

Primary Outcomes (1)

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

  Baseline

Secondary Outcomes (1)

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

  Baseline

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• 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.

  PMID: 32762899 BACKGROUND

• 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.

  PMID: 35665572 BACKGROUND

• 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.

  PMID: 23388002 BACKGROUND

• 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.

  PMID: 20124537 BACKGROUND

• 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.

  PMID: 18086931 BACKGROUND

• 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.

  PMID: 28183512 BACKGROUND

• 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.

  PMID: 17481445 BACKGROUND

• 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.

  PMID: 30025580 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Kerolos Kamel

CONTACT

+201282111275; Kerolosayman99@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09