Observational Study for Feasibility and Performance of Sub-millisievert Coronary Computed Tomography Angiography (CCTA) for Coronary Artery Anomalies (CAA) in Paediatric Patients

NCT03194763 | Completed

• 1 other identifier: 9785
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Congenital heart defects are the most frequent manifestation of congenital diseases (8 per 1000 live births). Imaging modalities play an increasing role in their diagnosis, follow-up, and pre/post-surgery check-up. Echocardiography usually provides a first line diagnosis, but Coronary CT Angiography (CCTA) also demonstrated its usefulness whenever accurate modelling of anatomic structures is required. CCTA is well defined for adult patients. This is not the case for paediatric population, which rises two main difficulties:

• The use of ionising radiation in young subjects involves a very radio-sensitive population, potentially subject to multiple exams during their follow up.
• Technical issues related to young patients: No breath-holding, uncontrolled movements during acquisition, very high heart rates (making ECG gating more complex) and very small structures. These conditions usually result in a deteriorated image quality or in radiation dose increase (retrospective gating). These two outcomes are not acceptable for both, clinician and patient. In this study, investigators make the hypothesis that despite difficult conditions stated above, ultra-low dose acquisitions may results in diagnostic quality acquisition, thanks to state of art CT technologies combined with acquisition parameters specially designed for that purpose. Investigators aim to demonstrate feasibility and performances of such exams.

Conditions

Coronary Artery Anomaly, Congenital

Outcome Measures

Primary Outcomes (1)

• CT diagnostic performance evaluation

  CT diagnostic performance evaluation using a semi-quantitative likert scale

  first day

Interventions

coronary angiography DIAGNOSTIC_TEST

computed tomography acquisitions performed on a revolution CT

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients from 0 to 18 years old with known or suspected coronay artery anomalies

You may qualify if:

• Patients from 0 to 18 years old
• Known or suspected coronary artery anomalies
• CCTA prescribed for regular follow up of the pathology
• No-objection of parents/legal representative of the patient
• Covered by social security

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital

Montpellier, 34295, France

Location

Related Publications (1)

• Le Roy J, Vernhet Kovacsik H, Zarqane H, Vincenti M, Abassi H, Lavastre K, Mura T, Lacampagne A, Amedro P. Submillisievert Multiphasic Coronary Computed Tomography Angiography for Pediatric Patients With Congenital Heart Diseases. Circ Cardiovasc Imaging. 2019 Feb;12(2):e008348. doi: 10.1161/CIRCIMAGING.118.008348.

  PMID: 30704282 BACKGROUND

MeSH Terms

Interventions

Coronary Angiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Heart Function Tests

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: July 1, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: May 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)