Coronary Artery Anomaly, Congenital Clinical Trial
— COROPEDIAOfficial title:
Observational Study for Feasibility and Performance of Sub-millisievert Coronary Computed Tomography Angiography (CCTA) for Coronary Artery Anomalies (CAA) in Paediatric Patients
| NCT number | NCT03194763 |
| Other study ID # | 9785 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 1, 2017 |
| Est. completion date | March 31, 2018 |
| Verified date | May 2019 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | March 31, 2018 |
| Est. primary completion date | March 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility |
Inclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
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. — View Citation
Ultra-low dose multiphasic coronary computed tomography angiography for pediatric patients with congenital heart diseases: A prospective cross-sectional study - 14/08/18 Doi : 10.1016/j.acvdsp.2018.06.036 Julien Le Roy, MSc a, b, c, Hélène Vernhet Kovacsik, MD, Ph.D. d, Hamid Zarqane, MD d, Marie Vincenti, MD a, b, Hamouda Abassi, MSc a, Kathleen Lavastre, MSc a, Thibault Mura, MD, Ph.D. e, Alain Lacampagne, Ph.D. b, Pascal Amedro, MD, Ph.D. a, b, ?
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CT diagnostic performance evaluation | CT diagnostic performance evaluation using a semi-quantitative likert scale | first day |