Clinical trial NCT06456970: Frequency of Metabolic Dysfunction Associated Fatty Liver Disease in Patients With Acute Coronary Syndromes
Official title: Frequency of Metabolic Dysfunction Associated Fatty Liver Disease in Patients With Acute Coronary Syndromes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fatty Liver
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any Patient above the age of 18 years presented with acute coronary syndromes {myocardial infarction (MI), non-ST elevation myocardial infarction (NSTEMI), unstable angina} underwent coronary angiography within admission.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assess frequency of MAFLD among patients with acute coronary syndromes (ACS).
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Taiseer Mohamed Kamal El Deen, resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Waleed Attia Hassan, A.professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Sahar Mohammed Hassany, professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mohamed Osman Abdelhameed, Lecturer
role: STUDY_DIRECTOR
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