Predictors of Aortic Root Dilatation in Tetralogy of Fallot Patients

NCT ID: NCT06081855

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-05-01

Brief Summary

• 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.

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.

Conditions

Congenital Heart Disease; Aortic Root Dilatation; Tetralogy of Fallot

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Repaired TOF

CT

Intervention Type: DIAGNOSTIC_TEST

Measuring aortic root diameter by CT

Unrepaired TOF

CT

Intervention Type: DIAGNOSTIC_TEST

Measuring aortic root diameter by CT

Interventions

CT

Measuring aortic root diameter by CT

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrahman Gamal Ahmed Ramadan

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr Elbadry, MD

Role: STUDY_CHAIR

Assiut University, Faculty of Medicine

Central Contacts

Abdelrahman أ Ramadan, MBBCH

Role: CONTACT

abdelrahman.ramadan@aun.edu.eg

+201011808028

Amr Elbadry, MD

Role: CONTACT

aelbadry@aun.edu.eg

+201060701601

References

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Other Identifiers

Aortic Root Dilatation in TOF

Identifier Type: -

Identifier Source: org_study_id