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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 (COROPEDIA)

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ClinicalTrials.gov Identifier: NCT03194763
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment
Coronary Artery Anomaly, Congenital Diagnostic Test: coronary angiography

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: coronary angiography
    computed tomography acquisitions performed on a revolution CT


Primary Outcome Measures :
  1. CT diagnostic performance evaluation [ Time Frame: first day ]
    CT diagnostic performance evaluation using a semi-quantitative likert scale



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients from 0 to 18 years old with known or suspected coronay artery anomalies
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier

Publications:
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, ⁎

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03194763     History of Changes
Other Study ID Numbers: 9785
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Congenital Abnormalities