Subclinical Cardiovascular Changes in NAFLD Patient (Predictive Value of Speckle Tracking Echocardiography )

NCT05790057 | Unknown

• 1 other identifier: cardiac complication in NAFLD
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

the goal of this study (observational study ) is to learn about the subclinical cardiovascular changes in patients with nonalcoholic fatty liver . the main questions it aims to answer are

1. 1.the role of speckle tracking echocardiogram in detection of subclinical cardiovascular complication in NAFLD patients
2. 2.the role of fibroscan in diagnosis of nonalcoholic fatty liver the participant will be examined by fibroscan and speckle tracking echocardiogram

Conditions

Liver Steatoses

Outcome Measures

Primary Outcomes (3)

• the sensitivity of fibroscan in diagnosis of NAFLD

  analysis of the results of fibroscan and test the sensitivity of fibroscan in measurement the degree of steatosis and diagnosis of NAFLD

  baseline

• role of speckle tracking echocardiogram in detection of subclinical cardiovascular complications of NAFLD

  speckle tracking echocardiogram will be used to to find any cardiac abnormality such as myocardial infarction , valvular diseases in NAFLD patients

  baseline

• comparison between conventional echocardiogram and speckle tracking echocardiogram in detection of subclinical cardiovascular complications of NAFLD patients

  comparison between the results and measurements of both conventional echocardiogram and speckle tracking echocardiogram

  baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

any patient above 18 years no specific gender is required , with no comorbidities ( not cardiac not hypertensive , no chronic liver disease , no hepatocellular carcinoma , not alcoholic

You may qualify if:

• Patients above age of 18 years old
• All patients showing degree of fibrosis and steatosis

You may not qualify if:

• Patients diagnosed with cardiac disease (previous or current )
• patients known to have chronic liver disease
• patients younger than 18 years old
• patients with hepatocellular cancer
• patients know to be alcoholic
• patients with previous history of hypertension

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Assuit, 71515, Egypt

Location

Related Publications (6)

• Kasper P, Martin A, Lang S, Kutting F, Goeser T, Demir M, Steffen HM. NAFLD and cardiovascular diseases: a clinical review. Clin Res Cardiol. 2021 Jul;110(7):921-937. doi: 10.1007/s00392-020-01709-7. Epub 2020 Jul 21.

  PMID: 32696080 BACKGROUND

• Newsome PN, Sasso M, Deeks JJ, Paredes A, Boursier J, Chan WK, Yilmaz Y, Czernichow S, Zheng MH, Wong VW, Allison M, Tsochatzis E, Anstee QM, Sheridan DA, Eddowes PJ, Guha IN, Cobbold JF, Paradis V, Bedossa P, Miette V, Fournier-Poizat C, Sandrin L, Harrison SA. FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study. Lancet Gastroenterol Hepatol. 2020 Apr;5(4):362-373. doi: 10.1016/S2468-1253(19)30383-8. Epub 2020 Feb 3.

  PMID: 32027858 BACKGROUND

• Oeda S, Tanaka K, Oshima A, Matsumoto Y, Sueoka E, Takahashi H. Diagnostic Accuracy of FibroScan and Factors Affecting Measurements. Diagnostics (Basel). 2020 Nov 12;10(11):940. doi: 10.3390/diagnostics10110940.

  PMID: 33198092 BACKGROUND

• Pathik P, Ravindra S, Ajay C, Prasad B, Jatin P, Prabha S. Fibroscan versus simple noninvasive screening tools in predicting fibrosis in high-risk nonalcoholic fatty liver disease patients from Western India. Ann Gastroenterol. 2015 Apr-Jun;28(2):281-286.

  PMID: 25830783 BACKGROUND

• Anstee QM, Mantovani A, Tilg H, Targher G. Risk of cardiomyopathy and cardiac arrhythmias in patients with nonalcoholic fatty liver disease. Nat Rev Gastroenterol Hepatol. 2018 Jul;15(7):425-439. doi: 10.1038/s41575-018-0010-0.

  PMID: 29713021 BACKGROUND

• Zamirian M MD, Samiee E MD, Moaref A MD, Abtahi F MD, Tahamtan M MD. Assessment of Subclinical Myocardial Changes in Non-Alcoholic Fatty Liver Disease: A Case-Control Study Using Speckle Tracking Echocardiography. Iran J Med Sci. 2018 Sep;43(5):466-472.

  PMID: 30214098 BACKGROUND

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• lobna m abdelwaheed, professor

  supervisor of the research ( professor of internal medicine Assiut university

  STUDY DIRECTOR

• soheir m kasem, professor

  supervisor of the research ( professor of internal medicine Assiut university

  STUDY DIRECTOR

Central Study Contacts

omar m magdy, postgraduate

CONTACT

01062983336; omar.megooz96@gmail.com

reem e mahdy, PHD

CONTACT

01096608866; reemezzat@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pricipal investigator , internal medicine resident

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 29, 2023
• Study Start: May 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

EG (1)