Observational Study for Feasibility and Performance of Sub-millisievert Coronary Computed Tomography Angiography (CCTA) for Coronary Artery Anomalies (CAA) in Paediatric Patients (COROPEDIA)
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|ClinicalTrials.gov Identifier: NCT03194763|
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : May 17, 2019
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.
|Condition or disease||Intervention/treatment|
|Coronary Artery Anomaly, Congenital||Diagnostic Test: coronary angiography|
Fifty paediatric patients are to be enrolled in this study. All these patients were prescribed a coronary angiography CT as part of their follow up for a known or suspected coronary artery anomaly.
Computed Tomography acquisitions are performed on a Revolution CT (GE Healthcare) using a wide detector aperture (160 mm), last generation of iterative reconstruction algorithm and specific reconstruction software reducing cardiac motion artefacts. A rotation time of 0.28 sec is used, with a slice thickness of 0.625 mm and a 0.625 mm reconstruction interval. The acquisition is ECG-gated (prospective) with kV and mAs depending on BMI, heart rate and heart rate variability of patients.
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Observational Study for Feasibility and Performance of Sub-millisievert Coronary Computed Tomography Angiography (CCTA) for Coronary Artery Anomalies (CAA) in Paediatric Patients|
|Actual Study Start Date :||July 1, 2017|
|Actual Primary Completion Date :||March 31, 2018|
|Actual Study Completion Date :||March 31, 2018|
- Diagnostic Test: coronary angiography
computed tomography acquisitions performed on a revolution CT
- CT diagnostic performance evaluation [ Time Frame: first day ]CT diagnostic performance evaluation using a semi-quantitative likert scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194763
|Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital|
|Montpellier, France, 34295|