Predictors of Aortic Root Dilatation in Tetralogy of Fallot Patients

October 7, 2023 updated by: Abdelrahman Gamal Ahmed Ramadan, Assiut University
  • To predict vulnerable patients for aortic root dilatation in TOF patients using CT as a reliable imaging modality, thus aiding early intervention, and identifying those who will require strict follow-up.
  • To assess the prevalence of TOF patients who developed aortic root dilatation, and those who were complicated with dissection, AR, and aneurysm, through collecting data from a large center (Aswan Heart Centre).
  • To investigate the relationship between age at repair and the diameter of aortic root.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Tetralogy of Fallot (TOF) occurs in approximately 3 to 5 of every 10,000 live births and is the most common cyanotic congenital heart defect and it exhibits four main features. These features are pulmonary stenosis, right ventricular hypertrophy, overriding aorta and ventricular septal defect. Moreover, since the survival of patients with congenital heart diseases has improved significantly in recent decades, long-term complications should be monitored cautiously. One of these complications is aortic root dilatation, attributed to increased and altered flow through the overriding aorta and an uneven sharing of conotruncal tissue between the aorta and pulmonary artery, particularly in patients who have not undergone early repair.

Despite the concern that TOF patients may harbor aortopathy that can lead to aortic regurgitation, aortic aneurysms, and, potentially, aortic dissection, the scope of the problem remains uncertain. Prevalence estimates of aortic root dilatation have ranged from 15% to 87% with the use of various criteria. Moderate to severe aortic regurgitation (AR) has also been reported in up to 12.5% of adults with TOF and dilated aortic roots. The incidence of aortic dissection and surgical intervention remains unknown. Moreover, features associated with aortic dilatation are not fully understood. Therefore, correlating and predicting vulnerable patients and identifying possible risk factors for aortic root dilatation in TOF patients, will enable more cautious follow-up and earlier intervention, thus decreasing possible morbidity and mortality.

Study Type

Observational

Enrollment (Estimated)

77

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 Contact Backup

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Sample size was calculated using Epi- Info7. Based on aortic dilatation is found in 84.6 in follow up CT [12] With a confidence limits 5% and a confidence level of 80% the minimum patients required for this study is 77 cases.

Description

Inclusion Criteria:

  • All patients with TOF who either underwent or have not yet had surgical correction.
  • All patients with Fallot-type DORV.
  • Patients should have survived until discharge and have at least one echocardiography and CT with full data related to one or more anatomic subcomponents of the aortic root, either before surgery or during follow-up, regardless of specific duration post repair.

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).

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
Repaired TOF
Diagnostic test: CT
Measuring aortic root diameter by CT
Unrepaired TOF
Diagnostic test: CT
Measuring aortic root diameter by CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aortic root diameters
Time Frame: Throughout the study duration, about 1 year

: Aortic root diameters at four levels:

  1. aortic annulus (AA)
  2. sinus of Valsalva (SoV)
  3. sinotubular junction (STJ)
  4. ascending aorta (AAo). AA will be measured as the inter-commissural distance in the aortic valve, SoV will be measured at the level of maximal diameter on the axial image, STJ will be measured at the level of transitional zone from STJ to AAo, and AAo will be measured at the level of the main pulmonary artery bifurcation. Aortic cross-sectional area will be calculated by π×(diameter/2)2 The largest diameters of each aortic structure as measured based on the chest CT 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. Echocardiography will be performed to check other cardiac deformities, including AR.
Throughout the study duration, about 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Aortic valve repair or surgical or transcatheter aortic valve replacement
Time Frame: Throughout the study duration, about 1 year
Throughout the study duration, about 1 year
Severity of AR at latest follow-up or before the earliest aortic valve or root intervention.
Time Frame: Throughout the study duration, about 1 year
Throughout the study duration, about 1 year

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Amr Elbadry, MD, Assiut University, Faculty of Medicine

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 (Estimated)

January 1, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

October 7, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aortic Root Dilatation in TOF

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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