NCT06456970

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jul 2024Jul 2026

First Submitted

Initial submission to the registry

June 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 9, 2024

Last Update Submit

June 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

fibroscanDEVICE

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)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients refused to participate.
  • Patients with history of alcohol or drug abuse.
  • Patients have hepatitis C or hepatitis B infection.
  • Patients have primary or secondary hepatic malignancies
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

    PMID: 28669328BACKGROUND
  • 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.

    PMID: 32775350BACKGROUND
  • 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.

    PMID: 18469838BACKGROUND
  • 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.

    PMID: 35370968BACKGROUND
  • 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.

    PMID: 35441719BACKGROUND
  • 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.

    PMID: 19758907BACKGROUND
  • 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.

    PMID: 28431047BACKGROUND
  • 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.

    PMID: 38194827BACKGROUND
  • 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.

    PMID: 28149317BACKGROUND
  • 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.

    PMID: 4650929BACKGROUND
  • 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.

    PMID: 14726171BACKGROUND
  • 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.

    PMID: 33006093BACKGROUND

Related Links

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Taiseer Mohamed Kamal El Deen, resident

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Waleed Attia Hassan, A.professor

    Assiut University

    STUDY DIRECTOR
  • Sahar Mohammed Hassany, professor

    Assiut University

    STUDY DIRECTOR
  • Mohamed Osman Abdelhameed, Lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Taiseer Mohamed Kamal El Deen, resident

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

June 9, 2024

First Posted

June 13, 2024

Study Start

July 1, 2024

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

June 13, 2024

Record last verified: 2024-06