Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-05 @ 5:44 PM
Study NCT ID:
NCT06575556
Status:
RECRUITING
Last Update Posted:
2024-08-28
First Post:
2024-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of MRI Instead of CT to Follow-up Ross Procedure With Loose Jacket Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2024-07-13', 'studyFirstSubmitQcDate': '2024-08-26', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of MRI measurements in comparison to CT using statistical analysis.', 'timeFrame': '1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The largest diameters of each aortic structure', 'timeFrame': '1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac imaging', 'Cardiac CT', 'Cardiac MRI', 'Ross procedure', 'Loose jacket technique'], 'conditions': ['Cardiac Imaging']}, 'referencesModule': {'references': [{'pmid': '26530243', 'type': 'BACKGROUND', 'citation': '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': '24725835', 'type': 'BACKGROUND', 'citation': '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': '21983074', 'type': 'BACKGROUND', 'citation': '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': '37938855', 'type': 'BACKGROUND', 'citation': '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': '37366156', 'type': 'BACKGROUND', 'citation': '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': '34422572', 'type': 'BACKGROUND', 'citation': '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': '32129834', 'type': 'BACKGROUND', 'citation': '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': '38522870', 'type': 'BACKGROUND', 'citation': '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': '25173340', 'type': 'BACKGROUND', 'citation': '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': '33309920', 'type': 'BACKGROUND', 'citation': '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': '16682313', 'type': 'BACKGROUND', 'citation': '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': '20211339', 'type': 'BACKGROUND', 'citation': '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': '34830578', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All paients who underwent Ross procedure with loose jacket technique at Aswan Heart Centre', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who underwent Ross procedure with loose jacket technique at Aswan Heart Centre, regardless of the indication and duration after surgery.\n* 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.\n\nExclusion Criteria:\n\n* 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).\n* Patients who have contra-indication for conducting a safe MRI scan. For instance, metallic implants that are incompatible with MRI.\n* Patients who underwent Ross procedure with technique other than loose jacket.'}, 'identificationModule': {'nctId': 'NCT06575556', 'briefTitle': 'Validation of MRI Instead of CT to Follow-up Ross Procedure With Loose Jacket Technique', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Validation of Magnetic Resonance Imaging Against Multidetector Computed Tomography After Ross Procedure Using Loose Jacket Technique', 'orgStudyIdInfo': {'id': 'MRI in Ross procedure'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who underwent Ross procedure with loose jacket technique', 'description': 'Patients who underwent Ross procedure with loose jacket technique regardless of the timing of surgery, all patients will undergo both CT and MRI scans', 'interventionNames': ['Diagnostic Test: Cardiac CT and MRI']}], 'interventions': [{'name': 'Cardiac CT and MRI', 'type': 'DIAGNOSTIC_TEST', 'description': '• Cardiac MRI Protocol\n\nThe 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.\n\n• CT Aortography Protocol:\n\nThe 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', 'armGroupLabels': ['Patients who underwent Ross procedure with loose jacket technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1242770', 'city': 'Aswān', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ramadan, MBBCH', 'role': 'CONTACT', 'email': 'abdelrahman.ramadan@aun.edu.eg', 'phone': '00201011808028'}], 'facility': 'Aswan Heart Centre (Magdi Yacoub Foundation)', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'centralContacts': [{'name': 'Abdelrahman Gamal Ahmed Ramadan, MBBCH', 'role': 'CONTACT', 'email': 'abdelrahman.ramadan@aun.edu.eg', 'phone': '01011808028'}], 'overallOfficials': [{'name': 'Abdelrahman Gamal Ahmed G. Ramadan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Abdelrahman Gamal Ahmed Ramadan', 'investigatorAffiliation': 'Assiut University'}}}}