Fatty LiverNCT06456970
Frequency of Metabolic Dysfunction Associated Fatty Liver Disease in Patients With Acute Coronary Syndromes
An observational study of Fatty Liver, run by Assiut University.
Trial summary
Aim of the research is to assess frequency of MAFLD among patients with acute coronary syndromes (ACS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatty Liver
- What is being tested?
- fibroscan
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Aim of the research is to assess frequency of MAFLD among patients with acute coronary syndromes (ACS).
Read the 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.
- Conditions
- Fatty Liver
- Being tested
- fibroscan
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taiseer Mohamed Kamal El Deen Hasanin Mohamed, Assiut University
- Investigators
- Taiseer Mohamed Kamal El Deen, resident, Principal investigator, Assiut UniversityWaleed Attia Hassan, A.professor, Study director, Assiut UniversitySahar Mohammed Hassany, professor, Study director, Assiut UniversityMohamed Osman Abdelhameed, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456970
- Sponsor's protocol ID
- MAFLD and ACS
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28669328Malnick 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.
PubMed 32775350Eddy 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.
PubMed 18469838Huang 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.
PubMed 35370968Ren 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.
PubMed 35441719Sianos 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.
PubMed 19758907Cavalcante 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.
PubMed 28431047Abosheaishaa 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.
PubMed 38194827Baharvand-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.
PubMed 28149317Keys 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.
PubMed 4650929WHO 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.
PubMed 14726171Eslam 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.
PubMed 33006093
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Metabolic Dysfunction Associated Fatty Liver Disease in Patients With Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT06456970
- Acronym / sponsor ID
- MAFLD and ACS
- Conditions
- Fatty Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fibroscanFibroscan 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) | Device | – |
Primary outcome
Assess frequency of MAFLD among patients with acute coronary syndromes (ACS).
Time frame: baseline
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 28669328Katsiki 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.
- Background: PubMed 32775350Malnick 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.
- Background: PubMed 18469838Eddy 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.
- Background: PubMed 35370968Huang 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.
- Background: PubMed 35441719Ren 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.
- Background: PubMed 19758907Sianos 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.
- Background: PubMed 28431047Cavalcante 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.
- Background: PubMed 38194827Abosheaishaa 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.
- Background: PubMed 28149317Baharvand-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.
- Background: PubMed 4650929Keys 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.
- Background: PubMed 14726171WHO 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.
- Background: PubMed 33006093Eslam 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.
- Is Nonalcoholic Fatty Liver Disease Indeed the Hepatic Manifestation of Metabolic Syndrome?Link provided by the sponsor.
- The Interplay between Alcoholic Liver Disease, Obesity, and the Metabolic SyndromeLink provided by the sponsor.
- The metabolic syndrome and cardiovascular risk: implications for clinical practiceLink provided by the sponsor.
- Association of Age of Metabolic Syndrome Onset With Cardiovascular Diseases: The Kailuan StudyLink provided by the sponsor.
- Relationship between NAFLD and coronary artery disease: A Mendelian randomization studyLink provided by the sponsor.
- The SYNTAX Score: an angiographic tool grading the complexity of coronary artery diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Fatty Liver
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taiseer Mohamed Kamal El Deen, resident principal investigator
Assiut University
Waleed Attia Hassan, A.professor study director
Assiut University
Sahar Mohammed Hassany, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taiseer Mohamed Kamal El Deen, resident (01080718330, totym036@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess frequency of MAFLD among patients with acute coronary syndromes (ACS). (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06456970, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.