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

Recruiting

• Conditions: Cardiac Imaging
• Interventions: Diagnostic Test: Cardiac CT and MRI

• Registration Number: NCT06575556
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-07-13
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28
• Primary Completion: 2024-12
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Accuracy of MRI measurements in comparison to CT using statistical analysis.	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.

Secondary Outcome Measures

Name	Time	Method
The largest diameters of each aortic structure	1 year	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.

Trial Locations

Locations (1)

Aswan Heart Centre (Magdi Yacoub Foundation); 🇪🇬 Aswan, Egypt