An observational study in Congenital Heart Disease, Aortic Root Dilatation and Tetralogy of Fallot, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by Assiut University · Observational
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Tetralogy of Fallot (TOF) occurs in approximately 3 to 5 of every 10,000 live births and is the most common cyanotic congenital heart defect and it exhibits four main features. These features are pulmonary stenosis, right ventricular hypertrophy, overriding aorta and ventricular septal defect. Moreover, since the survival of patients with congenital heart diseases has improved significantly in recent decades, long-term complications should be monitored cautiously. One of these complications is aortic root dilatation, attributed to increased and altered flow through the overriding aorta and an uneven sharing of conotruncal tissue between the aorta and pulmonary artery, particularly in patients who have not undergone early repair.
Despite the concern that TOF patients may harbor aortopathy that can lead to aortic regurgitation, aortic aneurysms, and, potentially, aortic dissection, the scope of the problem remains uncertain. Prevalence estimates of aortic root dilatation have ranged from 15% to 87% with the use of various criteria. Moderate to severe aortic regurgitation (AR) has also been reported in up to 12.5% of adults with TOF and dilated aortic roots. The incidence of aortic dissection and surgical intervention remains unknown. Moreover, features associated with aortic dilatation are not fully understood. Therefore, correlating and predicting vulnerable patients and identifying possible risk factors for aortic root dilatation in TOF patients, will enable more cautious follow-up and earlier intervention, thus decreasing possible morbidity and mortality.
92 studies on the registry are indexed under Tetralogy of Fallot; 25 are open to participants now.
This study's planned enrollment of 77 is below the median of 150 across 40 observational studies indexed under Tetralogy of Fallot.
Browse Tetralogy of Fallot studies →Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Tetralogy of Fallot, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Defects, Congenital. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Sample size was calculated using Epi- Info7. Based on aortic dilatation is found in 84.6 in follow up CT [12] With a confidence limits 5% and a confidence level of 80% the minimum patients required for this study is 77 cases.
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Exclusion Criteria:
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Diagnostic Test: CT
Diagnostic Test: CT
Measuring aortic root diameter by CT
Aortic root diameters
: Aortic root diameters at four levels: 1. aortic annulus (AA) 2. sinus of Valsalva (SoV) 3. sinotubular junction (STJ) 4. ascending aorta (AAo). AA will be measured as the inter-commissural distance in the aortic valve, SoV will be measured at the level of maximal diameter on the axial image, STJ will be measured at the level of transitional zone from STJ to AAo, and AAo will be measured at the level of the main pulmonary artery bifurcation. Aortic cross-sectional area will be calculated by π×(diameter/2)2 The largest diameters of each aortic structure as measured based on the chest CT will be re-calculated as z-scores. In our study, "significant dilatation of the aortic structures" is defined as 95% confidence interval (z-score≥2) in diameter of each aortic structures. Echocardiography will be performed to check other cardiac deformities, including AR.
Time frame: Throughout the study duration, about 1 year
Aortic valve repair or surgical or transcatheter aortic valve replacement
Time frame: Throughout the study duration, about 1 year
Severity of AR at latest follow-up or before the earliest aortic valve or root intervention.
Time frame: Throughout the study duration, about 1 year
No study locations are listed for this record.
Start is estimated for Jan 2024; primary completion for Feb 2025, 13 months later.
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This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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