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

August 26, 2024 updated by: Abdelrahman Gamal Ahmed Ramadan, Assiut University

Validation of Magnetic Resonance Imaging Against Multidetector Computed Tomography After Ross Procedure Using 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Aswan, Egypt, 1242770

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All paients who underwent Ross procedure with loose jacket technique at Aswan Heart Centre

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who underwent Ross procedure with loose jacket technique
Patients who underwent Ross procedure with loose jacket technique regardless of the timing of surgery, all patients will undergo both CT and MRI scans
Diagnostic test: Cardiac 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Abdelrahman Gamal Ahmed G. Ramadan, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 13, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MRI in Ross procedure

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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