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

NCT03194763 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2019-05-17

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

coronary angiography

computed tomography acquisitions performed on a revolution CT

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194763 on ClinicalTrials.gov