Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-30 @ 11:27 AM
Study NCT ID:
NCT05590858
Status:
COMPLETED
Last Update Posted:
2022-10-21
First Post:
2022-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Control on Coronary Inflammation Evaluated by FAI in ACS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 309}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-20', 'studyFirstSubmitDate': '2022-10-19', 'studyFirstSubmitQcDate': '2022-10-20', 'lastUpdatePostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pericoronary Fat attenuation index (FAI)', 'timeFrame': '2021.1.1-2022.10.31', 'description': 'The pericoronary FAI was defined as the mean CT attenuation of the pericoronary adipose tissue (-190 to -30 HU).\n\nPeri-stent FAI was measured around the stent segment of all 3 major epicardial coronary vessels.'}], 'secondaryOutcomes': [{'measure': 'Level of hsCRP', 'timeFrame': '2021.1.1-2022.10.31'}, {'measure': 'level of pro-inflammatory cytokines such as IL-2 and IL-6.', 'timeFrame': '2021.1.1-2022.10.31'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'acute coronary syndrome', 'coronary inflammation', 'coronary computed tomography angiography', 'fat attenuation index'], 'conditions': ['Inflammation Vascular']}, 'referencesModule': {'references': [{'pmid': '35023363', 'type': 'BACKGROUND', 'citation': 'Sun JT, Sheng XC, Feng Q, Yin Y, Li Z, Ding S, Pu J. Pericoronary Fat Attenuation Index Is Associated With Vulnerable Plaque Components and Local Immune-Inflammatory Activation in Patients With Non-ST Elevation Acute Coronary Syndrome. J Am Heart Assoc. 2022 Jan 18;11(2):e022879. doi: 10.1161/JAHA.121.022879. Epub 2022 Jan 13.'}, {'pmid': '39077018', 'type': 'DERIVED', 'citation': 'Jiang J, Yin Y, Li Y, Xu B, Zou Z, Ding S, Pu J. Impact of Glycemic Control on Coronary Inflammation Evaluated by Computed Tomography Pericoronary Fat Attenuation Index in Patients with Acute Coronary Syndrome. Rev Cardiovasc Med. 2023 Jul 14;24(7):203. doi: 10.31083/j.rcm2407203. eCollection 2023 Jul.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to clarify the relationship between blood glucose control and the FAI based pericoronary inflammation in low-risk ACS patients with or without diabetes. The results of this study are expected to provide evidence that quantitative assessment of pericoronary FAI helps monitor the local inflammatory activation in diabetic patients with poor glycemic control, therefore, pericoronary FAI evaluation, as a noninvasive imaging biomarker, plays an important role in early detecting coronary atherosclerosis risk in diabetes and allow timely providing appropriate risk reduction strategies in patients at high risk for future cardiovascular events.', 'detailedDescription': 'Coronary inflammation has been shown to be a cause of the significantly increased risk of cardiovascular disease (CVD) in diabetic patients. This study aimed to investigate the relationship between coronary local inflammation detected by pericoronary fat attenuation index (FAI) and different blood glucose control levels in low-risk acute coronary syndrome (ACS) patients with or without diabetes.A total of 309 patients with low-risk ACS were included in the analysis. Patients were classified into three groups: non-diabetes, well-regulated diabetes and poorly regulated diabetes, depend on the presence or absence of diabetes and the glycemic control evaluated based on a target HbA1c value of 7%. Pericoronary FAI around the proximal of left anterior descending artery (LAD), left circumflex artery (LCX), and right coronary artery (RCA) were evaluated by CCTA, while systemic inflammatory variables and other biochemical indicators were detected by flow cytometry. The results of this study are expected to provide evidence that quantitative assessment of pericoronary FAI helps monitor the local inflammatory activation in diabetic patients with poor glycemic control, therefore, pericoronary FAI evaluation, as a noninvasive imaging biomarker, plays an important role in early detecting coronary atherosclerosis risk in diabetes and allow timely providing appropriate risk reduction strategies in patients at high risk for future cardiovascular events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'low-risk ACS patients who underwent CCTA examination before elective coronary angiography between January 2019 and December 2020 at Renji Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients exhibited chest pain but troponin negative who suspected of low-risk ACS\\[17\\];\n* patients underwent CCTA examination before elective coronary angiography;\n* patients with at least one significant stenosis (≥50%) in major epicardial vessels based on coronary angiography.\n\nExclusion Criteria:\n\n* patients with missing preprocedural HbA1c values;\n* patients with insufficient image quality for FAI analysis,\n* patients with previous history of coronary revascularization or myocardial infarction, or chronic kidney disease requiring hemodialysis, or malignant tumor, or immune system disorders, or statin use within 3 months'}, 'identificationModule': {'nctId': 'NCT05590858', 'briefTitle': 'Glycemic Control on Coronary Inflammation Evaluated by FAI in ACS', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Impact of Glycemic Control on Coronary Inflammation Evaluated by Computed Tomography Pericoronary Fat Attenuation Index in Patients With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'FAI-DM in ACS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-diabetes', 'description': 'patients without diabetes'}, {'label': 'well-regulated diabetes', 'description': 'patients with diabetes and HbA1c ≤ 7%'}, {'label': 'poorly regulated diabetes', 'description': 'patients with diabetes and HbA1c \\> 7%'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Cardiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Song Ding, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}