Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 19, 2017
First Posted Date June 21, 2017
Last Update Posted Date May 17, 2019
Actual Study Start Date July 1, 2017
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2017)
CT diagnostic performance evaluation [ Time Frame: first day ]
CT diagnostic performance evaluation using a semi-quantitative likert scale
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03194763 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study for Feasibility and Performance of Sub-millisievert Coronary Computed Tomography Angiography (CCTA) for Coronary Artery Anomalies (CAA) in Paediatric Patients
Official Title Observational Study for Feasibility and Performance of Sub-millisievert Coronary Computed Tomography Angiography (CCTA) for Coronary Artery Anomalies (CAA) in Paediatric Patients
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.

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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients from 0 to 18 years old with known or suspected coronay artery anomalies
Condition Coronary Artery Anomaly, Congenital
Intervention Diagnostic Test: coronary angiography
computed tomography acquisitions performed on a revolution CT
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 19, 2017)
50
Original Estimated Enrollment Same as current
Actual Study Completion Date March 31, 2018
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03194763
Other Study ID Numbers 9785
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Montpellier
Study Sponsor University Hospital, Montpellier
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Montpellier
Verification Date May 2019