NCT05291858

Brief Summary

Evaluation of cardiac and extra cardiac vascular defects associated with Tetralogy of fallot in pediatric patients, regarding frequency and types of anomalies with assesment of multidetector computed tomography diagnostic value.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 30, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

March 14, 2022

Last Update Submit

March 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of cardiac and extra cardiac vascular anomalies associated with tetralogy of Fallot by MDCT and its repercussion on preoperative decision.

    The four main characteristics of TOF \[ventricular septal defect, overriding aorta, right ventricular outflow tract (RVOT) obstruction, and right ventricular hypertrophy\] and associated cardiac and extracardiac malformations will be analyzed and recorded using a sequential segmental approach. To compare the diagnostic performance of DSCT with that of TTE, we will categorize all the surgically confirmed associated cardiac and extracardiac vascular deformities into five groups, namely abnormal vena cava connection (AVCC), aortic artery and valve disorders, anomalies of the pulmonary artery and valve, deformities of the aortopulmonary vessels, and coronary artery anomalies (CAAs).

    within a year

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All preoperative TOF patients less than 18 years were included. All patients underwent MDCT and TTE preoperatively. All associated cardiac and extracardiac vascular abnormalities and their percentages will be recorded.

You may not qualify if:

  • Non-surgical patients
  • Patients with unstable clinical conditions
  • Renal insufficiency
  • Hypersensitivity to iodinated contrast.
  • Age range of included patients:
  • All pediatric patients less than 18 years were included. All patients underwent MDCT and TTE preoperatively. All associated cardiac and extracardiac vascular abnormalities and their percentages will be recorded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 23, 2022

Study Start

December 30, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2025

Last Updated

March 23, 2022

Record last verified: 2022-03