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

NCT ID: NCT06456970

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-07-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Fatty Liver

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Taiseer Mohamed Kamal El Deen Hasanin Mohamed

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Taiseer Mohamed Kamal El Deen, resident

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Waleed Attia Hassan, A.professor

Role: STUDY_DIRECTOR

Assiut University

Sahar Mohammed Hassany, professor

Role: STUDY_DIRECTOR

Assiut University

Mohamed Osman Abdelhameed, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Taiseer Mohamed Kamal El Deen, resident

Role: CONTACT

01080718330

References

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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.

Reference Type BACKGROUND
PMID: 28669328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32775350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18469838 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35370968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35441719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19758907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28431047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38194827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28149317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4650929 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14726171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33006093 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://pubmed.ncbi.nlm.nih.gov/19758907/

The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease

https://pubmed.ncbi.nlm.nih.gov/28431047/

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

https://pubmed.ncbi.nlm.nih.gov/38194827/

Association between non-alcoholic fatty liver disease and coronary artery disease outcomes: A systematic review and meta-analysis

https://pubmed.ncbi.nlm.nih.gov/28149317/

Prevalence of non-alcoholic fatty liver disease in patients with coronary artery disease

https://pubmed.ncbi.nlm.nih.gov/4650929/

Indices of relative weight and obesity

https://pubmed.ncbi.nlm.nih.gov/14726171/

Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies

https://pubmed.ncbi.nlm.nih.gov/33006093/

The Asian Pacific Association for the Study of the Liver clinical practice guidelines for the diagnosis and management of metabolic associated fatty liver disease

https://pubmed.ncbi.nlm.nih.gov/28669328/

Is Nonalcoholic Fatty Liver Disease Indeed the Hepatic Manifestation of Metabolic Syndrome?

https://pubmed.ncbi.nlm.nih.gov/32775350/

The Interplay between Alcoholic Liver Disease, Obesity, and the Metabolic Syndrome

https://pubmed.ncbi.nlm.nih.gov/18469838/

The metabolic syndrome and cardiovascular risk: implications for clinical practice

https://pubmed.ncbi.nlm.nih.gov/35370968/

Association of Age of Metabolic Syndrome Onset With Cardiovascular Diseases: The Kailuan Study

https://pubmed.ncbi.nlm.nih.gov/35441719/

Relationship between NAFLD and coronary artery disease: A Mendelian randomization study

Other Identifiers

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MAFLD and ACS

Identifier Type: -

Identifier Source: org_study_id

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