Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)MASLD-CACNCT07865936
Cardiovascular Risk Assessment and Coronary Calcium Score in Thai MASLD Patients
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Cardiovascular Disease (CVD), run by Watcharasak Chotiyaputta at 1 site in Thailand.
Trial summary
Metabolic dysfunction-associated steatotic liver disease (MASLD) is common in Thailand and is strongly linked to metabolic risk factors such as obesity, diabetes, hypertension, and dyslipidemia. Cardiovascular disease is the leading cause of death among patients with MASLD. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Cardiovascular Disease (CVD), Coronary Artery Calcification
- How many people
- 251 participants
- Where
- 1 siteThailand
- Study dates
- 24 Jun 2026to 23 Jun 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Thai adults aged 35-75 years diagnosed with MASLD who underwent coronary artery calcium scoring at Siriraj Hospital. Clinical, metabolic, liver disease severity, and CAC score data are collected for cardiovascular risk analysis.
Who may be able to join
- Asymptomatic
- Diagnosed MASLD by: Ultrasound showing fatty liver, or FibroScan CAP ≥ 248 dB/m
- Available liver fibrosis assessment (FIB-4, APRI)
- Complete clinical and laboratory data required for cardiovascular risk assessment
Who cannot join
- History of myocardial infarction, PCI, or CABG
- History of stroke or peripheral arterial disease
- History of heart failure, RV dysfunction, or pulmonary hypertension
- Chronic hepatitis B or C
- Autoimmune hepatitis, Wilson's disease, hemochromatosis
- Alcohol intake >30 g/day (men) or >20 g/day (women)
Show all 9Show fewer
- CKD stage 4-5 or ESRD
- Advanced cancer
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkoknoi, 10700
Watcharasak Chotiyaputta, M.D., +66 85-125-5489, watcharasak.cho@mahidol.ac.th
About this study
Official title: Association of Cardiovascular Disease Risk Assessment With Coronary Artery Calcium Score in Thai Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease
Metabolic dysfunction-associated steatotic liver disease (MASLD) is common in Thailand and is strongly linked to metabolic risk factors such as obesity, diabetes, hypertension, and dyslipidemia. Cardiovascular disease is the leading cause of death among patients with MASLD. Coronary artery calcium (CAC) scoring is a widely used marker of subclinical coronary atherosclerosis. This study aims to evaluate the association between cardiovascular risk assessment tools and CAC scores in Thai patients with MASLD to improve cardiovascular risk stratification in this population.
Read the detailed description
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a major public health concern in Thailand, with a high prevalence among individuals undergoing health evaluations. MASLD is closely associated with metabolic abnormalities and is recognized as an independent risk factor for cardiovascular disease (CVD). Although MASLD primarily affects the liver, multiple studies have shown that CVD is the leading cause of mortality in this population. Contributing mechanisms include insulin resistance, chronic low-grade inflammation, oxidative stress, and atherogenic dyslipidemia.
Coronary artery calcium (CAC) scoring, obtained through non-contrast cardiac CT, is a validated tool for detecting subclinical coronary atherosclerosis and predicting future cardiovascular events. Commonly used cardiovascular risk calculators-such as the Framingham Risk Score, ASCVD Risk Estimator, and UKPDS risk engine-were developed in Western populations and may not accurately reflect cardiovascular risk in Asian or Thai patients.
This observational study aims to investigate the relationship between cardiovascular risk assessment tools and CAC scores in Thai patients diagnosed with MASLD. Clinical data, metabolic parameters, liver disease severity, and CAC scores will be analyzed to determine how well existing risk calculators correlate with coronary calcification in this population. The findings may support improved cardiovascular risk stratification and help identify MASLD patients who may benefit from early cardiovascular evaluation.
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Cardiovascular Disease (CVD), Coronary Artery Calcification
- Keywords
- MASLD, Metabolic Dysfunction-Associated Steatotic Liver Disease, Coronary Artery Calcium (CAC), Liver Disease and Cardiovascular Risk
- Medical subject headings
- Cardiovascular Diseases, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MASLD Cohort | Thai adult patients diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD) who underwent coronary artery calcium (CAC) scoring at Siriraj Hospital. Clinical, metabolic, liver disease severity, and CAC score data are collected to evaluate the association between cardiovascular risk assessment tools and coronary calcification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between Thai CV Risk Score and Coronary Artery Calcium (CAC) Score in Thai MASLD patients
The study will evaluate the correlation between the Thai CV risk score and the coronary artery calcium (CAC) score in Thai patients diagnosed with MASLD. Clinical and metabolic parameters will be used to calculate ASCVD risk, and CAC scores will be obtained from non-contrast cardiac CT.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start24 Jun 2026
- Primary completion23 May 2027 (estimated)
- Study completion23 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Studies of the same condition, open and under way.
- 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
- 251 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Watcharasak Chotiyaputta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Watcharasak Chotiyaputta, Mahidol University
- Investigators
- Thammarin Khaoropphan, M.D., Study director, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865936
- Sponsor's protocol ID
- Si 568/2026
- Other IDs
- GAT-2026
- Acronym
- MASLD-CAC
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy protection and institutional policy regarding clinical data from Siriraj Hospital.
Publications
Writing Committee Members; Blumenthal RS, Morris PB, Gaudino M, Johnson HM, Anderson TS, Bittner VA, Blankstein R, Brewer LC, Cho L, de Ferranti SD, Gianos E, Gluckman TJ, Gradney KF, Isiadinso I, Lloyd-Jones DM, Marrs JC, Martin SS, McLain KH, Mehta LS, Mora S, Mulugeta WM, Natarajan P, Navar AM, Orringer CE, Polonsky TS, Reynolds HR, Saseen JJ, Shapiro MD, Soffer DE, Tynes SA, Villavaso CD, Virani SS, Wilkins JT. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2026 Apr 28;153(17):e1154-e1276. doi: 10.1161/CIR.0000000000001423. Epub 2026 Mar 13.
PubMed 41824552Gershon GS, Barr JR, Razavi AC, Yang Y, Momin E, Dzaye O, Whelton SP, Blaha MJ, Blumenthal RS, Sperling LS, De Cecco CN, van Assen M. Coronary artery calcium burden across the pooled cohort equation versus the American Heart Association PREVENT risk calculator. Am J Prev Cardiol. 2025 Sep 17;24:101301. doi: 10.1016/j.ajpc.2025.101301. eCollection 2025 Dec.
PubMed 41078705Neves PO, Andrade J, Moncao H. Coronary artery calcium score: current status. Radiol Bras. 2017 May-Jun;50(3):182-189. doi: 10.1590/0100-3984.2015.0235.
PubMed 28670030Ma G, Xu G, Huang H. Correlation between metabolic dysfunction-associated steatotic liver disease and subclinical coronary atherosclerosis in eastern China. Diabetol Metab Syndr. 2025 Jan 16;17(1):16. doi: 10.1186/s13098-025-01577-z.
PubMed 39815332Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
PubMed 31504418Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e563-e595. doi: 10.1161/CIR.0000000000000677. Epub 2019 Mar 17.
PubMed 30879339Tiansuwan N, Sasiprapha T, Jongjirasiri S, Unwanatham N, Thakkinstian A, Laothamatas J, Limpijankit T. Utility of coronary artery calcium in refining 10-year ASCVD risk prediction using a Thai CV risk score. Front Cardiovasc Med. 2023 Nov 2;10:1264640. doi: 10.3389/fcvm.2023.1264640. eCollection 2023.
PubMed 3802849722. UKPDS Cardiac Risk Calculator. Available from: https://www.mdapp.co/ukpds-cardiac-risk-calculator-215/.
21. ASCVD Risk Estimator Plus. Available from: https://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate/.
20. FHS Cardiovascular Disease (10-year risk). Available from: https://www.framinghamheartstudy.org/fhs-risk-functions/cardiovascular-disease-10-year-risk/.
19. Thai CV risk score. Available from: https://www.rama.mahidol.ac.th/cardio_vascular_risk/thai_cv_risk_score/.
Kavaric N, Klisic A, Ninic A. Cardiovascular Risk Estimated by UKPDS Risk Engine Algorithm in Diabetes. Open Med (Wars). 2018 Dec 31;13:610-617. doi: 10.1515/med-2018-0086. eCollection 2018.
PubMed 30847393Karlas T, Petroff D, Sasso M, Fan JG, Mi YQ, de Ledinghen V, Kumar M, Lupsor-Platon M, Han KH, Cardoso AC, Ferraioli G, Chan WK, Wong VW, Myers RP, Chayama K, Friedrich-Rust M, Beaugrand M, Shen F, Hiriart JB, Sarin SK, Badea R, Jung KS, Marcellin P, Filice C, Mahadeva S, Wong GL, Crotty P, Masaki K, Bojunga J, Bedossa P, Keim V, Wiegand J. Individual patient data meta-analysis of controlled attenuation parameter (CAP) technology for assessing steatosis. J Hepatol. 2017 May;66(5):1022-1030. doi: 10.1016/j.jhep.2016.12.022. Epub 2016 Dec 28.
PubMed 28039099Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. J Hepatol. 2023 Dec;79(6):1542-1556. doi: 10.1016/j.jhep.2023.06.003. Epub 2023 Jun 24.
PubMed 37364790Kalaiyarasi K, Sanchalika A, Hsien Min L, Wei Ming Y, Vishalkumar S, Kuo Chao Y, Jee Keem L, Sameer J, Terence HCW, Yen Ping T. Transient Elastography Is the Best-Performing Non-Invasive Test of Liver Fibrosis in Obese Asian Patients with Non-Alcoholic Fatty Liver Disease: A Pilot, Cross-Sectional Study. Medicina (Kaunas). 2024 Jan 17;60(1):169. doi: 10.3390/medicina60010169.
PubMed 38256429