NCT06575556

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

July 13, 2024

Last Update Submit

August 26, 2024

Conditions

Cardiac Imaging

Keywords

Cardiac imagingCardiac CTCardiac MRIRoss procedureLoose jacket technique

Outcome Measures

Primary Outcomes (1)

  • Accuracy of MRI measurements in comparison to CT using statistical analysis.

    We will use bland altman plots to visualize the degree of agreement between the two raters and identify any systematic bias. The closer the difference to zero, the better.

    1 year

Secondary Outcomes (1)

  • The largest diameters of each aortic structure

    1 year

Study Arms (1)

Patients who underwent Ross procedure with loose jacket technique

Patients who underwent Ross procedure with loose jacket technique regardless of the timing of surgery, all patients will undergo both CT and MRI scans

Diagnostic Test: Cardiac CT and MRI

Interventions

Cardiac CT and MRIDIAGNOSTIC_TEST

• 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 will be used to assess aortic root dimensions

Patients who underwent Ross procedure with loose jacket technique

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All paients who underwent Ross procedure with loose jacket technique at Aswan Heart Centre

You may qualify if:

  • 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.

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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan Heart Centre (Magdi Yacoub Foundation)

Aswān, 1242770, Egypt

RECRUITING

Related Publications (13)

  • 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: 26530243BACKGROUND

  • 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: 24725835BACKGROUND

  • 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: 21983074BACKGROUND

  • 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: 37938855BACKGROUND

  • 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: 37366156BACKGROUND

  • 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: 34422572BACKGROUND

  • 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: 32129834BACKGROUND

  • 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: 38522870BACKGROUND

  • Erbel R, Aboyans V, Boileau C, Bossone E, Bartolomeo RD, Eggebrecht H, Evangelista A, Falk V, Frank H, Gaemperli O, Grabenwoger M, Haverich A, Iung B, Manolis AJ, Meijboom F, Nienaber CA, Roffi M, Rousseau H, Sechtem U, Sirnes PA, Allmen RS, Vrints CJ; ESC Committee for Practice Guidelines. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2014 Nov 1;35(41):2873-926. doi: 10.1093/eurheartj/ehu281. Epub 2014 Aug 29. No abstract available.

    PMID: 25173340BACKGROUND

  • Poskaite P, Pamminger M, Kranewitter C, Kremser C, Reindl M, Reiter G, Piccini D, Dumfarth J, Henninger B, Tiller C, Holzknecht M, Reinstadler SJ, Klug G, Metzler B, Mayr A. Self-navigated 3D whole-heart MRA for non-enhanced surveillance of thoracic aortic dilation: A comparison to CTA. Magn Reson Imaging. 2021 Feb;76:123-130. doi: 10.1016/j.mri.2020.12.003. Epub 2020 Dec 9.

    PMID: 33309920BACKGROUND

  • 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: 16682313BACKGROUND

  • 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: 20211339BACKGROUND

  • 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: 34830578BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Abdelrahman Gamal Ahmed G. Ramadan

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelrahman Gamal Ahmed Ramadan, MBBCH

CONTACT

01011808028abdelrahman.ramadan@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 13, 2024

First Posted

August 28, 2024

Study Start

January 1, 2024

Primary Completion

December 1, 2024

Study Completion

July 1, 2025

Last Updated

August 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)