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Recruiting NCT06575556

Validation of MRI Instead of CT to Follow-up Ross Procedure With Loose Jacket Technique

— Observational Cardiac Imaging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cardiac CT and MRI.
Who it may be relevant to
Registry conditions: Cardiac Imaging. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Validation of Magnetic Resonance Imaging Against Multidetector Computed Tomography After Ross Procedure Using Loose Jacket Technique

Overview

Patients who underwent Ross procedure with loose jacket technique will be enrolled in this study and undergo CT and MRI follow-up to compare between both modalities.

Interventions

  • Diagnostic test Cardiac CT and MRI
    • Cardiac MRI Protocol The cardiac MRI protocol will include cine imaging, aortic flow, and 3D navigator of the aorta. These sequences will be performed to assess aortic root dimensions, including aortic root, sinuses of Valsalva, and sinotubular junction and ascending aorta diameters. • CT Aortography Protocol: The CT aortography protocol will include non-contrast and contrast-enhanced CT imaging. The non-contrast images will be used for calcium scoring, while the contrast-enhanced images wi

Primary outcome measures

  • Accuracy of MRI measurements in comparison to CT using statistical analysis. [Time frame: 1 year]
Secondary outcome measures (1)
  • The largest diameters of each aortic structure [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • All patients who underwent Ross procedure with loose jacket technique at Aswan Heart Centre, regardless of the indication and duration after surgery.
  • Patients should have survived until discharge and underwent at least one echocardiography with full data related to one or more anatomic subcomponents of the aortic root before surgery.

Exclusion criteria

  • 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).
  • Patients who have contra-indication for conducting a safe MRI scan. For instance, metallic implants that are incompatible with MRI.
  • Patients who underwent Ross procedure with technique other than loose jacket.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Aswan Heart Centre (Magdi Yacoub Foundation) — Aswān

Publications

  • Artemiou P, Schusterova I, Tohatyova A, Cocherova J, Krcho P, Sabol F. Follow-up after the Ross procedure, how significant it is, case reports of three patients. J Cardiothorac Surg. 2015 Nov 3;10:144. doi: 10.1186/s13019-015-0369-8. PMID 26530243
  • Ruzmetov M, Welke KF, Geiss DM, Buckley K, Fortuna RS. Failed autograft after the ross procedure in children: management and outcome. Ann Thorac Surg. 2014 Jul;98(1):112-8. doi: 10.1016/j.athoracsur.2014.02.038. Epub 2014 Apr 12. PMID 24725835
  • Juthier F, Vincentelli A, Pincon C, Banfi C, Ennezat PV, Marechaux S, Prat A. Reoperation after the Ross procedure: incidence, management, and survival. Ann Thorac Surg. 2012 Feb;93(2):598-604; discussion 605. doi: 10.1016/j.athoracsur.2011.06.083. Epub 2011 Oct 8. PMID 21983074
  • Notenboom ML, Melina G, Veen KM, De Robertis F, Coppola G, De Siena P, Navarra EM, Gaer J, Ibrahim MEK, El-Hamamsy I, Takkenberg JJM, Yacoub MH. Long-Term Clinical and Echocardiographic Outcomes Following the Ross Procedure: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2024 Jan 1;9(1):6-14. doi: 10.1001/jamacardio.2023.4090. PMID 37938855
  • Notenboom ML, Schuermans A, Etnel JRG, Veen KM, van de Woestijne PC, Rega FR, Helbing WA, Bogers AJJC, Takkenberg JJM. Paediatric aortic valve replacement: a meta-analysis and microsimulation study. Eur Heart J. 2023 Sep 7;44(34):3231-3246. doi: 10.1093/eurheartj/ehad370. PMID 37366156
  • Afifi A, Hosny H, Mahgoub A, Yacoub M. The Ross procedure-the loose jacket technique. Ann Cardiothorac Surg. 2021 Jul;10(4):544-545. doi: 10.21037/acs-2020-rp-20. No abstract available. PMID 34422572
  • Yacoub MH, Tsang V, Sarathchandra P, Jensen H, Hughes S, Latif N. Long-term adaptive versus maladaptive remodelling of the pulmonary autograft after the Ross operation. Eur J Cardiothorac Surg. 2020 May 1;57(5):977-985. doi: 10.1093/ejcts/ezaa019. PMID 32129834
  • Yacoub MH, Notenboom ML, Melina G, Takkenberg JJM. Surgical Heritage: You Had to Be There, Ross: The Comeback Kid. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2024;27:37-41. doi: 10.1053/j.pcsu.2023.10.001. Epub 2023 Nov 7. PMID 38522870

Identifiers

NCT: NCT06575556 · MRI in Ross procedure

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗