Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-02-22 @ 7:26 PM
Study NCT ID:
NCT06449092
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Significance of Remnant Cholesterol and Carotid Intima Media Thickness in Patients With MAFLD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2024-06-03', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To detect the significance of remnant cholesterol in detection severity of MAFLD', 'timeFrame': 'From Jan 2025 to Jan 2026', 'description': 'lipid profile in MAFLD patients to detect remnant cholesterol'}, {'measure': 'To detect the relationship between carotid intima-media thickness and remnant cholesterol in MAFLD and prediction of cardiovascular effect.', 'timeFrame': 'From Jan 2025 to Jan 2026', 'description': 'color doppler and echocardiography in MAFLD patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Detect the Significance of Remnant Cholesterol in Detection Severity of MAFLD']}, 'descriptionModule': {'briefSummary': '1. To detect the significance of remenant cholesterol in detection severity of MAFLD\n2. To detect the significance of carotid intima-media thickness in MAFLD', 'detailedDescription': 'Non-alcoholic fatty liver disease (NAFLD) is fatty infiltration of the liver in the absence of other causes of steatosis, such as alcohol consumption characterized by excessive fat accumulation in liver \\>5-10% of its weight encompassing a spectrum of increasingly severe clinico-pathological conditions - nonalcoholic fatty liver (NAFL) and nonalcoholic steato-hepatitis (NASH) with or without fibrosis/cirrhosis. Since NAFLD is frequently associated with further metabolic comorbidities such as obesity, type 2 diabetes mellitus, or dyslipidemia, it is generally considered as the hepatic manifestation of the metabolic syndrome A growing body of evidence also indicates that NAFLD is strongly associated with an increased risk of major CVD events and other cardiac complications (ie, cardiomyopathy, cardiac valvular calcification and cardiac arrhythmias), independently of traditional cardiovascular risk factors NAFLD has also been associated with an increase in the carotid intima- media thickness (CIMT), independent of conventional CVD risk factors. CIMT is a marker of early atherosclerosis and has been shown to predict increased risks of myocardial in-farction and stroke Fatty liver index (FLI) has been proposed as an accurate, convenient, and economic surrogate of the severity of NAFLD. Remnant cholesterol refers to the cholesterol content carried by triglyceride-rich lipoproteins, which include non-LDL-C and nonhigh density lipoprotein-cholesterol (HDL-C) A large number of studies have reported that serum remnant cholesterol levels were positively associated with the risk of coronary artery disease NAFLD\n\n, type 2 diabetes , and metabolic syndrome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include patients presented to Fibroscan clinic, Internal medicine department at Assiut University hospitals within 1 year', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study will include adult patients (≥18 years) presented to fibroscan clinic and diagnosed as MAFLD.\n\nExclusion Criteria:\n\n1. Patients Known previous cardiac disease ( cardiovascular disease, heart failure, arrhythmia )\n2. Patients Known liver cirrhosis\n3. septic patients\n4. Patients have malignancy'}, 'identificationModule': {'nctId': 'NCT06449092', 'acronym': 'MAFLD', 'briefTitle': 'The Significance of Remnant Cholesterol and Carotid Intima Media Thickness in Patients With MAFLD', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Significance of Remnant Cholesterol and Carotid Intima Media Thickness in Patients With MAFLD', 'orgStudyIdInfo': {'id': 'Severity of MAFLD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lipid profile', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['color doppler'], 'description': 'carotid intima media thickness'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Ahmed Kh Nazier', 'role': 'CONTACT', 'email': 'ak0555012@gmail.com', 'phone': '01005897058'}, {'name': 'Marwa Mo Mahmoud', 'role': 'CONTACT', 'email': 'marwaabokresha@aun.edu.eg', 'phone': '01000580208'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ahmed Khaled Mohammed', 'investigatorFullName': 'Ahmed Khaled Mohammed', 'investigatorAffiliation': 'Assiut University'}}}}