Validation of MRI Instead of CT to Follow-up Ross Procedure With Loose Jacket Technique
ConditionCardiac Imaging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
All paients who underwent Ross procedure with loose jacket technique at Aswan Heart Centre
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Cardiac CT and MRI
Diagnostic 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
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Patients who underwent Ross procedure with loose jacket technique1 intervention
Trial outcomes
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.
Time frame
1 yearSecondary 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.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov