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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06575556
Enrollment
70
Registered
2024-08-28
Start date
2024-01-01
Completion date
2025-07-31
Last updated
2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Imaging

Keywords

Cardiac imaging, Cardiac CT, Cardiac MRI, Ross procedure, Loose jacket technique

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.

Interventions

DIAGNOSTIC_TESTCardiac 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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of MRI measurements in comparison to CT using statistical analysis.1 yearWe 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.

Secondary

MeasureTime frameDescription
The largest diameters of each aortic structure1 yearThe 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.

Countries

Egypt

Contacts

Primary ContactAbdelrahman Gamal Ahmed Ramadan, MBBCH
abdelrahman.ramadan@aun.edu.eg01011808028

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026