Clinical trial NCT06575556: Validation of MRI Instead of CT to Follow-up Ross Procedure With Loose Jacket Technique
Official title: Validation of Magnetic Resonance Imaging Against Multidetector Computed Tomography After Ross Procedure Using Loose Jacket Technique
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Imaging
Keywords: Cardiac imaging
Cardiac CT
Cardiac MRI
Ross procedure
Loose jacket technique
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All paients who underwent Ross procedure with loose jacket technique at Aswan Heart Centre

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of MRI measurements in comparison to CT using statistical analysis.
timeFrame: 1 year
Secondary outcomes:
measure: The largest diameters of each aortic structure
timeFrame: 1 year
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan Heart Centre (Magdi Yacoub Foundation)
Study officials:
affiliation: Assiut University
name: Abdelrahman Gamal Ahmed G. Ramadan
role: PRINCIPAL_INVESTIGATOR
References:
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