Frequency of Metabolic Dysfunction Associated Fatty Liver Disease in Patients With Acute Coronary Syndromes

Fatty Liver Clinical Trial

Official title:

Frequency of Metabolic Dysfunction Associated Fatty Liver Disease in Patients With Acute Coronary Syndromes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456970
• Other study ID #: MAFLD and ACS
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: June 2024
• Source: Assiut University
• Contact: Taiseer Mohamed Kamal El Deen, resident
• Phone: 01080718330
• Email: totym036[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim of the research is to assess frequency of MAFLD among patients with acute coronary syndromes (ACS).

Description:

Hepatic manifestation of metabolic syndrome (MS) is known as Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD). MAFLD could be complicated by serious events as steatohepatitis, cirrhosis and malignant liver. The characteristics histological findings in those patients are macrovesicular steatosis. The prevalence of MAFLD has doubled over the last 20 years.

Globally, based on many reported studies, it's well-known that in 25-28% of deaths in patients with Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD) , coronary artery disease (CAD) is accused to be the leading cause.

Patients with MAFLD are known to have more complex coronary artery disease in angiography. But the effect on clinical outcome and mortality is not known. Furthermore, the impact of MAFLD on acute coronary syndrome (ACS) is not clear. Moreover, in patients with metabolic syndrome the presence of MAFLD would be associated with severe form of CAD as noticed by angiography where there was increased in number of affected vessels and multivariate regression analysis found that MAFLD as the only independent factor affecting coronary score.

The SYNTAX score was prospectively developed for the SYNTAX trial to grade the anatomical complexity of coronary lesions in patients with lt main coronary arterty (LM) or three-vessel disease . It was found to be an independent predictor of long-term major adverse cardiac and cerebrovascular events (MACCE) and of death.

While the available data clearly support a role of MAFLD in initiating and progression of CAD in non-diabetic patients is still to be searched. MAFLD might play a part in the pathogenesis of CAD through the overexpression and systemic release of several inflammatory, hemostatic and oxidative-stress mediators or via contributing to whole-body insulin resistance and atherogenic dyslipidemia.

Based on the lack of studies that discussed the effect of MAFLD on patients with ACS ,we designed this study trying to asses the effect of MAFLD on the severity of ACS.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Any Patient above the age of 18 years old presented with acute coronary syndromes {myocardial infarction (MI), non-ST elevation myocardial infarction (NSTEMI), unstable angina} underwent coronary angiography within admission.

Exclusion Criteria:

1. Patients refused to participate.

2. Patients with history of alcohol or drug abuse.

3. Patients have hepatitis C or hepatitis B infection.

4. Patients have primary or secondary hepatic malignancies

5. Pregnant women.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Fatty Liver
• Liver Diseases

Intervention

Device:
• fibroscan
Fibroscan examination with controlled attenuation parameter"CAP" (Echosens FibroScan ® Compact 530) for evaluation of steatosis and its degree (by CAP score) and fibrosis stage by liver stiffness measurement(LSM)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (12)

Abosheaishaa H, Hussein M, Ghallab M, Abdelhamid M, Balassiano N, Ahammed MR, Baig MA, Khan J, Elshair M, Soliman MY, Abdelwahed M, Ali A, Alzamzamy A, Nassar M. Association between non-alcoholic fatty liver disease and coronary artery disease outcomes: A systematic review and meta-analysis. Diabetes Metab Syndr. 2024 Jan;18(1):102938. doi: 10.1016/j.dsx.2023.102938. Epub 2024 Jan 3. — View Citation

Baharvand-Ahmadi B, Sharifi K, Namdari M. Prevalence of non-alcoholic fatty liver disease in patients with coronary artery disease. ARYA Atheroscler. 2016 Jul;12(4):201-205. — View Citation

Cavalcante R, Sotomi Y, Mancone M, Whan Lee C, Ahn JM, Onuma Y, Lemos PA, van Geuns RJ, Park SJ, Serruys PW. Impact of the SYNTAX scores I and II in patients with diabetes and multivessel coronary disease: a pooled analysis of patient level data from the SYNTAX, PRECOMBAT, and BEST trials. Eur Heart J. 2017 Jul 1;38(25):1969-1977. doi: 10.1093/eurheartj/ehx138. — View Citation

Eddy DM, Schlessinger L, Heikes K. The metabolic syndrome and cardiovascular risk: implications for clinical practice. Int J Obes (Lond). 2008 May;32 Suppl 2:S5-10. doi: 10.1038/ijo.2008.28. — View Citation

Eslam M, Sarin SK, Wong VW, Fan JG, Kawaguchi T, Ahn SH, Zheng MH, Shiha G, Yilmaz Y, Gani R, Alam S, Dan YY, Kao JH, Hamid S, Cua IH, Chan WK, Payawal D, Tan SS, Tanwandee T, Adams LA, Kumar M, Omata M, George J. The Asian Pacific Association for the Study of the Liver clinical practice guidelines for the diagnosis and management of metabolic associated fatty liver disease. Hepatol Int. 2020 Dec;14(6):889-919. doi: 10.1007/s12072-020-10094-2. Epub 2020 Oct 1. — View Citation

Huang Z, Wang X, Ding X, Cai Z, Li W, Chen Z, Fang W, Cai Z, Lan Y, Chen G, Wu W, Chen Z, Wu S, Chen Y. Association of Age of Metabolic Syndrome Onset With Cardiovascular Diseases: The Kailuan Study. Front Endocrinol (Lausanne). 2022 Mar 17;13:857985. doi: 10.3389/fendo.2022.857985. eCollection 2022. — View Citation

Katsiki N, Perez-Martinez P, Anagnostis P, Mikhailidis DP, Karagiannis A. Is Nonalcoholic Fatty Liver Disease Indeed the Hepatic Manifestation of Metabolic Syndrome? Curr Vasc Pharmacol. 2018;16(3):219-227. doi: 10.2174/1570161115666170621075619. — View Citation

Keys A, Fidanza F, Karvonen MJ, Kimura N, Taylor HL. Indices of relative weight and obesity. J Chronic Dis. 1972 Jul 1;25(6):329-43. doi: 10.1016/0021-9681(72)90027-6. No abstract available. — View Citation

Malnick S, Maor Y. The Interplay between Alcoholic Liver Disease, Obesity, and the Metabolic Syndrome. Visc Med. 2020 Jun;36(3):198-205. doi: 10.1159/000507233. Epub 2020 Apr 23. — View Citation

Ren Z, Simons PIHG, Wesselius A, Stehouwer CDA, Brouwers MCGJ. Relationship between NAFLD and coronary artery disease: A Mendelian randomization study. Hepatology. 2023 Jan 1;77(1):230-238. doi: 10.1002/hep.32534. Epub 2022 May 18. — View Citation

Sianos G, Morel MA, Kappetein AP, Morice MC, Colombo A, Dawkins K, van den Brand M, Van Dyck N, Russell ME, Mohr FW, Serruys PW. The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease. EuroIntervention. 2005 Aug;1(2):219-27. No abstract available. — View Citation

WHO Expert Consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet. 2004 Jan 10;363(9403):157-63. doi: 10.1016/S0140-6736(03)15268-3. Erratum In: Lancet. 2004 Mar 13;363(9412):902. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess frequency of MAFLD among patients with acute coronary syndromes (ACS).	patients with acute coronary syndrome will be evaluated if they have MAFLD and then we will know frequency of MAFLD among patients with acute coronary syndromes (ACS)	baseline

External Links

•   Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies
•   Association between non-alcoholic fatty liver disease and coronary artery disease outcomes: A systematic review and meta-analysis
•   Association of Age of Metabolic Syndrome Onset With Cardiovascular Diseases: The Kailuan Study
•   Impact of the SYNTAX scores I and II in patients with diabetes and multivessel coronary disease: a pooled analysis of patient level data from the SYNTAX, PRECOMBAT, and BEST trials
•   Indices of relative weight and obesity
•   Is Nonalcoholic Fatty Liver Disease Indeed the Hepatic Manifestation of Metabolic Syndrome?
•   Prevalence of non-alcoholic fatty liver disease in patients with coronary artery disease
•   Relationship between NAFLD and coronary artery disease: A Mendelian randomization study
•   The Asian Pacific Association for the Study of the Liver clinical practice guidelines for the diagnosis and management of metabolic associated fatty liver disease
•   The Interplay between Alcoholic Liver Disease, Obesity, and the Metabolic Syndrome
•   The metabolic syndrome and cardiovascular risk: implications for clinical practice
•   The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease