Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-01-04 @ 5:10 AM
Study NCT ID:
NCT06642259
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Triglyceride Glucose Index and Residual SYNTAX Score in STEMI Patients Undergoing PPCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 185}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-12', 'studyFirstSubmitDate': '2024-09-18', 'studyFirstSubmitQcDate': '2024-10-12', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. To check correlation between triglyceride glucose (TyG) index and residual SYNTAX score (RSS) in STEMI patients undergoing PPCI', 'timeFrame': 'baseline', 'description': '1\\. To check correlation between triglyceride glucose (TyG) index and residual SYNTAX score (RSS) in STEMI patients undergoing PPCI.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['STEMI - ST Elevation Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The goal of this study To check correlation between triglyceride glucose (TyG) index and residual SYNTAX score (RSS) in STEMI patients undergoing PPCI.\n\n2\\. Impact of both TyG index and RSS in STEMI patients undergoing PPCI on LV EF recovery after 3 months using LV speckle tracking.\n\n3\\. Impact of RSS and TyG index in STEMI patients undergoing PPCI on short term MACE at 3 months duration.', 'detailedDescription': 'ST-elevation myocardial infarction (STEMI) is known as a life-threatening complication of coronary artery disease (CAD) and it is one of the leading causes of death all over the world. Primary percutaneous coronary intervention (PPCI) of the culprit vessel in patients with STEMI is standard clinical practice .\n\nAt the time of PPCI, 40-65% of the patients exhibit one or more concomitant coronary lesions (i.e., multivessel disease (MVD)). The presence of narrowed coronaries other than those related to index ischemia in patients with STEMI is suggested as a feature associated with adverse clinical outcomes .\n\nThe recently developed residual SYNTAX Score (RSS) (developed 2012 and validated in 2013) is an objective, quantitative measure of the degree and complexity of residual stenosis after percutaneous coronary intervention (PCI) .It was developed to quantitatively assess the degree and complexity of residual stenoses, based on recalculating the SYNTAX score from coronary angiography after PCI . Higher RSS has been associated with worse outcome in patients undergoing angiography-mediated PCI .\n\nInsulin resistance (IR) is an important risk factor for the development of CAD . It is defined as a state in which a greater than normal amount of insulin is required to elicit a quantitatively normal response .\n\nPrevious studies have shown an independent association between IR and CVD. IR is tightly associated with increased cardiovascular morbidity and mortality by adversely modifying well-established cardiovascular risk factors such as dyslipidemia and hypertension and by causing endothelial dysfunction .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with STEMI and will undergo PPCI and fulfilling our inclusion criteria over a period of 6 months will be enrolled in our study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patient who are between 18 and 80 years old who present to our hospital (Assiut university heart hospital) with STEMI and eligible for primary PCI as treatment of choice according to guidelines, will be included in our study.\n\nExclusion Criteria:\n\n* Patient who refuse to undergo revasculariztion using primary PCI.\n* Patient who will die before withdraw of laboratory blood sample.\n* Patient with previous PCI and/or CABG.\n* Patient with underlying co-morbidity with life expectancy less than 1 year (end stage liver disease, end stage renal disease on regular dialysis, active malignancy).\n* Patient with failed canalization of infarct related artery.\n* Patient referred to CABG after angiography.\n* Patient who is unconscious after cardiac arrest .'}, 'identificationModule': {'nctId': 'NCT06642259', 'briefTitle': 'Correlation Between Triglyceride Glucose Index and Residual SYNTAX Score in STEMI Patients Undergoing PPCI', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Correlation Between Triglyceride Glucose Index and Residual SYNTAX Score in ST-elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': '(TyG) index and SYNTAX'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Echocardiography', 'type': 'RADIATION', 'description': 'ECHO'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohammad Medhat, MD student', 'role': 'CONTACT', 'email': 'mohammedmedhat1907@gmail.com', 'phone': '01157138440'}, {'name': 'Amir Khalifa, DR', 'role': 'CONTACT', 'email': 'amirkhalifa85@gmail.com', 'phone': '01002393557'}], 'overallOfficials': [{'name': 'Salwa Roshdy, Pro', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'mohammad medhat elsayed hasan', 'investigatorAffiliation': 'Assiut University'}}}}