Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06575556

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cardiac Imaging

Sex eligibility

All sexes

Study type

Observational

Primary location

Aswan Heart Centre (Magdi Yacoub Foundation)

Aswān, 1242770, Egypt

Location status: Recruiting

Location contact

Ramadan, MBBCH

CONTACT

[email protected]

00201011808028

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. The largest diameters of each aortic structure

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman Gamal Ahmed Ramadan, MBBCH

CONTACT

[email protected]

01011808028

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.