Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-04 @ 12:46 PM
Study NCT ID:
NCT06541132
Status:
RECRUITING
Last Update Posted:
2024-08-21
First Post:
2024-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positive Association of US-FLI With the Severity of CAD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-04-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2024-08-02', 'studyFirstSubmitQcDate': '2024-08-02', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SYNTAX score', 'timeFrame': 'at baseline', 'description': 'The complexity of coronary artery disease (CAD) is a predictor of cardiovascular events in patients with \\>50 % diameter stenosis as determined by SYNTAX score. The range of US-FLI is 0-8. Fatty liver was diagnosed when US-FLI ≥ 2.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Metabolic Dysfunction-associated Fatty Liver Disease', 'SYNTAX score', 'Ultrasonography'], 'conditions': ['Coronary Artery Disease of Significant Bypass Graft', 'Metabolic Dysfunction-associated Fatty Liver Disease', 'SYNTAX Score', 'Ultrasonography']}, 'referencesModule': {'references': [{'pmid': '32278004', 'type': 'BACKGROUND', 'citation': 'Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.'}, {'pmid': '28641784', 'type': 'BACKGROUND', 'citation': 'Ballestri S, Nascimbeni F, Baldelli E, Marrazzo A, Romagnoli D, Targher G, Lonardo A. Ultrasonographic fatty liver indicator detects mild steatosis and correlates with metabolic/histological parameters in various liver diseases. Metabolism. 2017 Jul;72:57-65. doi: 10.1016/j.metabol.2017.04.003. Epub 2017 Apr 13.'}, {'pmid': '30170074', 'type': 'BACKGROUND', 'citation': 'Buckley AJ, Thomas EL, Lessan N, Trovato FM, Trovato GM, Taylor-Robinson SD. Non-alcoholic fatty liver disease: Relationship with cardiovascular risk markers and clinical endpoints. Diabetes Res Clin Pract. 2018 Oct;144:144-152. doi: 10.1016/j.diabres.2018.08.011. Epub 2018 Aug 28.'}, {'pmid': '25013373', 'type': 'BACKGROUND', 'citation': 'Liu Z, Que S, Xu J, Peng T. Alanine aminotransferase-old biomarker and new concept: a review. Int J Med Sci. 2014 Jun 26;11(9):925-35. doi: 10.7150/ijms.8951. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'As a multisystem disease, metabolic dysfunction-associated fatty liver disease (MAFLD) is closely linked to the onset and progression of coronary heart disease (CHD). Ultrasonographic fatty liver indicator (US-FLI) is a semi-quantitative tool for evaluating the degree of hepatic steatosis. Our study aims to explore the relationship between US-FLI based on MAFLD and the severity of CHD.', 'detailedDescription': '204 patients who had invasive coronary angiography performed between July 2022 and December 2023 at the cardiology department of the Second Affiliated Hospital of Chongqing Medical University were included in this study. Collect clinical information and abdominal ultrasound images from each patient. Hepatic steatosis which quantified by US-FLI was evaluated by the echo contrast between liver and kidney, posterior attenuation of ultrasound beam, areas of focal sparing, display of hepatic vessels, gallbladder wall and diaphragm. Fatty liver was diagnosed when US-FLI≥2. The severity of CHD was evaluated using the SYNTAX score (SS), and a total of 100 CHD patients were ultimately diagnosed. CHD patients were further divided into the low-risk group (SS ≤ 22) (54 cases) and the medium-high-risk group (SS≥23) (46 cases). Multivariate logistic regression model was used to assess the relationship between US-FLI and SS in patients with MAFLD. The receiver operating characteristic curve was used to determine the accuracy, sensitivity and specificity of US-FLI in predicting SS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All research subjects were from the Second Affiliated Hospital of Chongqing Medical University', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years old\n* Patients underwent ICA due to chest pain, chest tightness or other reasons in our hospital from August 2022 to December 2023 were included in our study\n\nExclusion Criteria:\n\n* Incomplete clinical data\n* previous coronary stent implantation\n* no abdominal ultrasound examination\n* poor ultrasound image quality\n* congenital heart disease\n* tumor\n* thyroid diseases and infectious diseases'}, 'identificationModule': {'nctId': 'NCT06541132', 'briefTitle': 'Positive Association of US-FLI With the Severity of CAD', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing Medical University'}, 'officialTitle': 'Positive Association Between Ultrasonographic Fatty Liver Indicator and the Severity of Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'ChongqingM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-CAD group', 'description': 'non-coronary artery disease group'}, {'label': 'CAD group', 'description': 'coronary artery disease group', 'interventionNames': ['Other: Observational study without human intervention']}, {'label': 'SS≤22 group', 'description': 'SYNTAX score ≤22'}, {'label': 'SS≥23 group', 'description': 'SYNTAX score ≥23', 'interventionNames': ['Other: Observational study without human intervention']}], 'interventions': [{'name': 'Observational study without human intervention', 'type': 'OTHER', 'description': 'Observational study without human intervention', 'armGroupLabels': ['CAD group', 'SS≥23 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400000', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tingqiu Wang, Bachelor', 'role': 'CONTACT', 'email': 'w857683014@163.com', 'phone': '17815370539'}], 'facility': 'The Second Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Tingqiu Wang', 'role': 'CONTACT', 'email': 'w857683014@163.com', 'phone': '+8617815370539'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tingqiu Wang', 'investigatorAffiliation': 'Chongqing Medical University'}}}}