Cardiac ImagingNCT06575556

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

An observational study of Cardiac Imaging, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Cardiac Imaging
What is being tested?: Cardiac CT and MRI
How many people: 70 participants
Where: 1 siteEgypt
Study dates: 1 Jan 2024to Jul 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Abdelrahman Gamal Ahmed Ramadan, MBBCH contact

01011808028

abdelrahman.ramadan@aun.edu.eg

Egypt1 site, 1 recruiting

Aswan Heart Centre (Magdi Yacoub Foundation)
Aswān, 1242770
Ramadan, MBBCH, 00201011808028, abdelrahman.ramadan@aun.edu.eg
Recruiting

Other trials in Egypt

About this study

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

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.

Conditions: Cardiac Imaging
Being tested: Cardiac CT and MRI
Keywords: Cardiac imaging, Cardiac CT, Cardiac MRI, Ross procedure, Loose jacket technique

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06575556
Study group	Role	What they receive
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 Receives: Diagnostic Test: Cardiac CT and MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 year

Secondary outcomes (1)

The largest diameters of each aortic structure
The largest diameters of each aortic structure 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.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 2024Jul 2025

First posted28 Aug 2024
Study start1 Jan 2024
Primary completionDec 2024 (estimated)
Study completionJul 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Cardiac ImagingStudies of the same condition, open and under way.
More trials run by Assiut UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06575556
Sponsor's protocol ID: MRI in Ross procedure
Status last verified: Aug 2024
First submitted: 13 Jul 2024
Last updated: 28 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 38522870
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.
PubMed 25173340
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.
PubMed 33309920
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.
PubMed 16682313
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.
PubMed 20211339
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.
PubMed 34830578

Want to know more?

Abdelrahman Gamal Ahmed Ramadan, MBBCH

01011808028

abdelrahman.ramadan@aun.edu.eg

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cardiac Imaging trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of Magnetic Resonance Imaging Against Multidetector Computed Tomography After Ross Procedure Using Loose Jacket Technique
ClinicalTrials.gov ID: NCT06575556
Acronym / sponsor ID: MRI in Ross procedure
Conditions: Cardiac Imaging
Keywords: Cardiac imaging, Cardiac CT, Cardiac MRI, Ross procedure, Loose jacket technique
Study type: Observational
Recruitment status: Unknown status
Enrolment: 70 participants (estimated)
Lead sponsor: Assiut UniversityUniversity, hospital or other
Study start: 1 Jan 2024 (actual)
Primary completion: Dec 2024 (estimated)
Study completion: Jul 2025 (estimated)
First posted: 28 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Patients who underwent Ross procedure with loose jacket technique	–	Diagnostic Test: Cardiac CT and MRIPatients who underwent Ross procedure with loose jacket technique regardless of the timing of surgery, all patients will undergo both CT and MRI scans

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All paients who underwent Ross procedure with loose jacket technique at Aswan Heart Centre

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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 will be used to assess aortic root dimensions	Diagnostic test	Patients who underwent Ross procedure with loose jacket technique

Primary outcome

Accuracy of MRI measurements in comparison to CT using statistical analysis.
Time frame: 1 year
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 secondary outcome

The largest diameters of each aortic structure
Time frame: 1 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
Background: PubMed 26530243Artemiou 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.
Background: PubMed 24725835Ruzmetov 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.
Background: PubMed 21983074Juthier 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.
Background: PubMed 37938855Notenboom 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.
Background: PubMed 37366156Notenboom 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.
Background: PubMed 34422572Afifi 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.
Background: PubMed 32129834Yacoub 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.
Background: PubMed 38522870Yacoub 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.
Background: PubMed 25173340Erbel 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.
Background: PubMed 33309920Poskaite 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.
Background: PubMed 16682313Colan 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.
Background: PubMed 20211339Gautier 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Abdelrahman Gamal Ahmed Ramadan, MBBCH contact

01011808028

abdelrahman.ramadan@aun.edu.eg

Abdelrahman Gamal Ahmed G. Ramadan principal investigator

Assiut University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Imaging, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Abdelrahman Gamal Ahmed Ramadan, MBBCH (01011808028, abdelrahman.ramadan@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of MRI measurements in comparison to CT using statistical analysis. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06575556, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.