[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593751":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":10,"responsibleParty":26,"collaborators":10,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":10,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":38,"maxAge":10,"enrollmentInfo":39,"targetDuration":10,"studyType":42,"phases":10,"briefSummary":43,"conditions":44,"keywords":10,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":10},{"fullName":5,"class":6},"Assiut University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with TOF",null,"The study cohort consists of adult patients (≥18 years) with previously repaired Tetralogy of Fallot (TOF) who underwent routine clinical follow-up, including cardiac imaging, functional testing, and laboratory investigations. Patients included underwent surgical repair using either valve-sparing techniques or valved conduits and had follow-up assessments performed at least 3 months post-surgery. Data will be retrospectively collected from medical records, imaging databases, and clinical documentation. The cohort includes patients in sinus rhythm or with a documented history of ventricular arrhythmia, all of whom were referred for routine cardiovascular magnetic resonance (CMR) imaging and other functional assessments as part of standard care.",[13],"Diagnostic Test: CMR, stress ECG, Holter, BnP",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","CMR, stress ECG, Holter, BnP","This study involves no experimental intervention. All data were collected retrospectively from patients with repaired Tetralogy of Fallot (TOF) who underwent standard clinical follow-up. As part of routine care, patients received comprehensive multimodal functional assessment, including:\n\nCardiac Magnetic Resonance Imaging (CMR) with feature-tracking strain analysis\n\nTransthoracic Echocardiography\n\nExercise stress testing (treadmill ECG using Bruce protocol)\n\n12-lead ECG and 24-hour Holter monitoring\n\nLaboratory evaluation including NT-proBNP levels\n\nNYHA functional class assessment",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Alaa AA Abdelhafez","CONTACT","01140522334","alaaabdelrahman300@aun.edu.eg",{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Alaa Abdelrahman Abdelgaber Abdelhafez","Doctor","100593751","quality-of-life-in-operated-adult-patients-with-tetralogy-of-fallot-and-correlation-with-myocardial-strain-analysis-by-cmr-100593751",false,"NCT07010510","Quality of Life in Operated Adult Patients With Tetralogy of Fallot and Correlation With Myocardial Strain Analysis by CMR","Quality of Life in Operated Adult Patients With Tetralogy of Fallot and Correlation With Myocardial Strain Analysis by Cardiac Magnetic Resonance Imaging and Exercise Test","* Inclusion criteria:\n\n  * Adult TOF patients who were referred for surgical repair of TOF either valve sparing repair (VSR) or valved conduit (stented valve conduits, freestyle valved conduits, bio-prosthesis, or homograft).\n  * Adults (age ≥18 years) with repaired TOF.\n  * Undergoing routine CMR for clinical follow-up.\n  * Sinus rhythm or known history of ventricular arrhythmia.\n* Exclusion criteria:\n\n  * Confounding other congenital defects e.g. AV canal.\n  * Significant aortic regurgitation or stenosis.\n  * Significant mitral regurgitation.\n  * Residual significant major aorto-pulmonary collaterals (MAPCAs).\n  * Patients with contraindications to CMR (e.g., pacemakers, severe renal impairment, claustrophobic).\n  * Poor-quality CMR images precluding strain analysis.","ALL","18 Years",{"count":40,"type":41},100,"ESTIMATED","OBSERVATIONAL","Title:\n\nFunctional Assessment and Arrhythmia Prediction in Adult Patients with Repaired Tetralogy of Fallot Using a Multimodality Approach\n\nBackground:\n\nTetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect. Surgical repair has improved survival into adulthood, but long-term complications like arrhythmias and heart failure remain common. Assessing health-related quality of life (HRQOL) and cardiac function is essential.\n\nAim:\n\nAssess functional status of adult patients with repaired TOF using a multimodal approach, including myocardial strain analysis via CMR.\n\nIdentify predictors of arrhythmia using strain and clinical parameters.\n\nMethods:\n\nDesign: Prospective observational study over one year.\n\nPopulation: Adults (≥18 years) with repaired TOF undergoing follow-up CMR.\n\nAssessments:\n\nClinical evaluation (NYHA class)\n\nEchocardiography (RV size, function, valve status)\n\nLaboratory tests (BNP, NT-proBNP)\n\nExercise testing (METs, VO₂ max)\n\nECG \\& 24-hour Holter monitoring (QRS duration, arrhythmias)\n\nCMR (volumes, flow, fibrosis, strain analysis of RA, RV, LV)\n\nOutcomes:\n\nPrimary: Functional assessment of repaired TOF patients.\n\nSecondary: Detection of arrhythmia and need for further interventions (e.g., ICD or ablation).\n\nStatistical Analysis:\n\nComparison between arrhythmic and non-arrhythmic groups.\n\nLogistic regression for predictors of arrhythmia.\n\nROC analysis to determine optimal strain cut-off values.\n\nEthical Considerations:\n\nEthics committee approval and informed consent.\n\nData confidentiality maintained.",[45],"TOF","NOT_YET_RECRUITING","2025-05-30",{"date":49,"type":50},"2025-06-08","ACTUAL",{"date":52,"type":41},"2025-06",{"date":54,"type":41},"2030-01",{"name":5,"class":6}]