Predictors of Aortic Root Dilatation in Tetralogy of Fallot Patients

NCT06081855 | Unknown

• 1 other identifier: Aortic Root Dilatation in TOF
• Study Type: observational
• Target: 77
• Locations: 0 countries
• Sites: N/A

Brief Summary

• To predict vulnerable patients for aortic root dilatation in TOF patients using CT as a reliable imaging modality, thus aiding early intervention, and identifying those who will require strict follow-up.
• To assess the prevalence of TOF patients who developed aortic root dilatation, and those who were complicated with dissection, AR, and aneurysm, through collecting data from a large center (Aswan Heart Centre).
• To investigate the relationship between age at repair and the diameter of aortic root.

Conditions

Congenital Heart Disease; Aortic Root Dilatation; Tetralogy of Fallot

Outcome Measures

Primary Outcomes (1)

• 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.

  Throughout the study duration, about 1 year

Secondary Outcomes (2)

• Aortic valve repair or surgical or transcatheter aortic valve replacement

  Throughout the study duration, about 1 year

• Severity of AR at latest follow-up or before the earliest aortic valve or root intervention.

  Throughout the study duration, about 1 year

Study Arms (2)

Repaired TOF

Diagnostic Test: CT

Unrepaired TOF

Diagnostic Test: CT

Interventions

CT DIAGNOSTIC_TEST

Measuring aortic root diameter by CT

Repaired TOF; Unrepaired TOF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• All patients with TOF who either underwent or have not yet had surgical correction.
• All patients with Fallot-type DORV.
• Patients should have survived until discharge and have at least one echocardiography and CT with full data related to one or more anatomic subcomponents of the aortic root, either before surgery or during follow-up, regardless of specific duration post repair.

You may not qualify if:

• \- Patients who have contraindication for conducting cardiac CT scan. For instance, dye sensitivity, pregnancy, CKD, in addition to patients who have factors that interfere with CT image quality as metallic objects within the chest (e.g. Pacemaker).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (12)

• Expert Consensus Panel:; Miller JR, Stephens EH, Goldstone AB, Glatz AC, Kane L, Van Arsdell GS, Stellin G, Barron DJ, d'Udekem Y, Benson L, Quintessenza J, Ohye RG, Talwar S, Fremes SE, Emani SM, Eghtesady P. The American Association for Thoracic Surgery (AATS) 2022 Expert Consensus Document: Management of infants and neonates with tetralogy of Fallot. J Thorac Cardiovasc Surg. 2023 Jan;165(1):221-250. doi: 10.1016/j.jtcvs.2022.07.025. Epub 2022 Oct 26.

  PMID: 36522807 BACKGROUND

• Goldstein BH, Petit CJ, Qureshi AM, McCracken CE, Kelleman MS, Nicholson GT, Law MA, Meadows JJ, Zampi JD, Shahanavaz S, Mascio CE, Chai PJ, Romano JC, Batlivala SP, Maskatia SA, Asztalos IB, Kamsheh AM, Healan SJ, Smith JD, Ligon RA, Pettus JA, Juma S, Raulston JEB, Hock KM, Pajk AL, Eilers LF, Khan HQ, Merritt TC, Canter M, Juergensen S, Rinderknecht FA, Bauser-Heaton H, Glatz AC. Comparison of Management Strategies for Neonates With Symptomatic Tetralogy of Fallot. J Am Coll Cardiol. 2021 Mar 2;77(8):1093-1106. doi: 10.1016/j.jacc.2020.12.048.

  PMID: 33632484 BACKGROUND

• Niwa K, Siu SC, Webb GD, Gatzoulis MA. Progressive aortic root dilatation in adults late after repair of tetralogy of Fallot. Circulation. 2002 Sep 10;106(11):1374-8. doi: 10.1161/01.cir.0000028462.88597.ad.

  PMID: 12221055 BACKGROUND

• Mongeon FP, Gurvitz MZ, Broberg CS, Aboulhosn J, Opotowsky AR, Kay JD, Valente AM, Earing MG, Lui GK, Fernandes SM, Gersony DR, Cook SC, Ting JG, Nickolaus MJ, Landzberg MJ, Khairy P; Alliance for Adult Research in Congenital Cardiology (AARCC). Aortic root dilatation in adults with surgically repaired tetralogy of fallot: a multicenter cross-sectional study. Circulation. 2013 Jan 15;127(2):172-9. doi: 10.1161/CIRCULATIONAHA.112.129585. Epub 2012 Dec 6.

  PMID: 23224208 BACKGROUND

• Chong WY, Wong WH, Chiu CS, Cheung YF. Aortic root dilation and aortic elastic properties in children after repair of tetralogy of Fallot. Am J Cardiol. 2006 Mar 15;97(6):905-9. doi: 10.1016/j.amjcard.2005.09.141. Epub 2006 Feb 3.

  PMID: 16516599 BACKGROUND

• Niwa K. Aortic root dilatation in tetralogy of Fallot long-term after repair--histology of the aorta in tetralogy of Fallot: evidence of intrinsic aortopathy. Int J Cardiol. 2005 Aug 18;103(2):117-9. doi: 10.1016/j.ijcard.2004.07.002.

  PMID: 16080967 BACKGROUND

• Rathi VK, Doyle M, Williams RB, Yamrozik J, Shannon RP, Biederman RW. Massive aortic aneurysm and dissection in repaired tetralogy of Fallot; diagnosis by cardiovascular magnetic resonance imaging. Int J Cardiol. 2005 May 11;101(1):169-70. doi: 10.1016/j.ijcard.2004.05.037. No abstract available.

  PMID: 15860407 BACKGROUND

• Konstantinov IE, Fricke TA, d'Udekem Y, Robertson T. Aortic dissection and rupture in adolescents after tetralogy of Fallot repair. J Thorac Cardiovasc Surg. 2010 Nov;140(5):e71-3. doi: 10.1016/j.jtcvs.2010.06.045. Epub 2010 Aug 1. No abstract available.

  PMID: 20674941 BACKGROUND

• Colan SD, McElhinney DB, Crawford EC, Keane JF, Lock JE. Validation and re-evaluation of a discriminant model predicting anatomic suitability for biventricular repair in neonates with aortic stenosis. J Am Coll Cardiol. 2006 May 2;47(9):1858-65. doi: 10.1016/j.jacc.2006.02.020. Epub 2006 Apr 17.

  PMID: 16682313 BACKGROUND

• Gautier M, Detaint D, Fermanian C, Aegerter P, Delorme G, Arnoult F, Milleron O, Raoux F, Stheneur C, Boileau C, Vahanian A, Jondeau G. Nomograms for aortic root diameters in children using two-dimensional echocardiography. Am J Cardiol. 2010 Mar 15;105(6):888-94. doi: 10.1016/j.amjcard.2009.11.040.

  PMID: 20211339 BACKGROUND

• Mohammed AFA, Frick M, Kerst G, Hatam N, Elgamal MF, Essa KM, Hovels-Gurich HH, Vazquez-Jimenez JF, Zayat R. Proximal Aortic Dilatation and Pulmonary Valve Replacement in Patients with Repaired Tetralogy of Fallot: Is There a Relationship? A Cardiac Magnetic Resonance Imaging Study. J Clin Med. 2021 Nov 15;10(22):5296. doi: 10.3390/jcm10225296.

  PMID: 34830578 BACKGROUND

• Kim W, Kwak JG, Cho S, Kim WH. Ten-year follow-up of dilatation of aortic structures in Fallot-type anomalies. Pediatr Cardiol. 2023 Oct;44(7):1552-1559. doi: 10.1007/s00246-023-03225-7. Epub 2023 Jul 5.

  PMID: 37405457 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Amr Elbadry, MD

  Assiut University, Faculty of Medicine

  STUDY CHAIR

Central Study Contacts

Abdelrahman أ Ramadan, MBBCH

CONTACT

+201011808028; abdelrahman.ramadan@aun.edu.eg

Amr Elbadry, MD

CONTACT

+201060701601; aelbadry@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 13, 2023
• Study Start: January 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: May 1, 2025
• Last Updated: October 13, 2023

Record last verified: 2023-10