Coronary Artery Anomaly, CongenitalCOROPEDIANCT03194763
Observational Study for Feasibility and Performance of Sub-millisievert Coronary Computed Tomography Angiography (CCTA) for Coronary Artery Anomalies (CAA) in Paediatric Patients
An observational study of Coronary Artery Anomaly, Congenital, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Coronary Artery Anomaly, Congenital
- What is being tested?
- coronary angiography
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2017to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients from 0 to 18 years old with known or suspected coronay artery anomalies
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Montpellier, 34295
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Coronary Artery Anomaly, Congenital
- Being tested
- coronary angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary angiographyDiagnostic test
computed tomography acquisitions performed on a revolution CT
What is being measured
The primary outcome is the main question the study is designed to answer.
CT diagnostic performance evaluation
CT diagnostic performance evaluation using a semi-quantitative likert scale
Measured: first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Jul 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Anomaly, CongenitalStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194763
- Sponsor's protocol ID
- 9785
- Acronym
- COROPEDIA
- Status last verified
- May 2019
- First submitted
- 19 Jun 2017
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30704282
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for Feasibility and Performance of Sub-millisievert Coronary Computed Tomography Angiography (CCTA) for Coronary Artery Anomalies (CAA) in Paediatric Patients
- ClinicalTrials.gov ID
- NCT03194763
- Acronym / sponsor ID
- COROPEDIA / 9785
- Conditions
- Coronary Artery Anomaly, Congenital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients from 0 to 18 years old with known or suspected coronay artery anomalies
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary angiographycomputed tomography acquisitions performed on a revolution CT | Diagnostic test | – |
Primary outcome
CT diagnostic performance evaluation
Time frame: first day
CT diagnostic performance evaluation using a semi-quantitative likert scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Background: PubMed 30704282Le 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Anomaly, Congenital, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT diagnostic performance evaluation (time frame: first day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03194763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.