Cardiac Congenital DefectsNCT06381128
Coronary Arteries Anomalies by CT in Children With CHD
An observational study of Cardiac Congenital Defects, run by Assiut University.
Trial summary
Delineate coronary artery anatomy and detection of coronary anomalies in children with complex cardiac anomalies by cardiac CT-angiography before total surgical correction. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Cardiac Congenital Defects
- What is being tested?
- Cardiac CT
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 day to 18 years
- All sexes
- Child, Adult
Study population: -Children aged from 1 day to 18 years old with congenital heart disease and undergoing surgical correction.
Who may be able to join
- Children aged from 1 day to 18 years old with congenital heart disease and undergoing surgical correction.
Who cannot join
- 1-Children had isolated coronary anatomy anomalies.
- 2-Children had medical coronary artery disease i.e. Kawasaki disease.
- 3-Children with CHD and not candidate for surgical correction .
- 4-Children with CHD with past history of cardiac surgery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Detection of Coronary Arteries Anomalies by Computed Tomography Angiography in Children With Congenital Heart Disease
Delineate coronary artery anatomy and detection of coronary anomalies in children with complex cardiac anomalies by cardiac CT-angiography before total surgical correction.
Read the detailed description
Congenital heart diseases (CHD) form an important spectrum of pediatric diseases causing significant morbidity and mortality. Due to inter-related embryology of the heart and development of the coronary arteries, there is a great variability in coronary artery patterns in patients with CHD [1].
The spectrum of coronary artery anomalies ranges from benign / incidental findings to significant cardiac morbidity in infancy or increased risk of cardiac sudden death in childhood or adolescence [2]. Abnormalities can be found in the coronary artery origin, course, and size or the number of vessels. Isolated anomalies of coronary artery origins, in those without structural heart disease, had an estimated incidence of 0.7% [3]. Coronary artery anomalies have a higher incidence in children with congenital heart disease, ranging from an incidence of 5% in those with coarctation [4] to 7% in tetralogy of Fallot [5] and up to 37% in single-ventricle physiologies [6]. Identifying these anomalies has become an important part of the preoperative evaluation to avoid inadvertent injury and has been shown to be effectively diagnosed with modern CT techniques compared to surgical visualization and catheter angiography [6,7]. System of coronary artery origin and branching is of great help to surgeons who dedicate their efforts to the treatment of congenital heart disease [8].
Coronary artery imaging in children is frequently challenging due to small size, high heart rates, and motion artifacts from cardiac pulsation, respiration, and the patients themselves, which results in technical or procedural difficulties [9].
Imaging modalities for evaluating coronary arteries in children include echocardiography, conventional invasive angiography, magnetic resonance imaging (MRI), and computed tomography (CT). Transthoracic echocardiography is widely used as the primary imaging approach. However, it is impaired by its limited ability to fully characterize coronary anatomy, by poor acoustic windows, and by operator dependency [10].
Magnetic resonance imaging (MRI), also provides information on cardiac anatomy and function, allowing 3-dimensional coronary artery imaging without the use of ionizing radiation.However, it is impaired by long acquisition time requiring prolonged patient cooperation, which may not be possible in children without general anesthesia, and bylimited spatial resolution which makes coronary evaluation beyond originassessment difficult [11].
Computed tomography (CT) angiography is often the firstline diagnostic modality of choice for noninvasive imaging of the coronary arteries in both adults and children. CT is rapidly acquired and can be performed in the setting of multiple support devices. Compared with cardiac MRI and transthoracic echocardiography, CT provides excellent spatial resolution with superior visualization of the entire course of the coronary arteries [12].
Recent advances in CT technology have allowed for dramatic decreases in radiation dose while maintaining theexcellent spatial resolution that allows for detailed anatomical evaluation [13].
Coronary artery abnormalities in children may be congenital or acquired. Congenital anomalies include a complex group of disorders occurring as isolated conditions or in the spectrum of congenital heart disease.Acquired coronary anomalies are mainly secondary to Kawasaki disease or surgery when congenital heart disease repair involves coronary manipulation. Increasing evidence is supporting the role of CT in general for coronary evaluation of these patients [14,15]. The Coronary artery anomalies are grouped under four subtypes, i.e. anomalies of origin and course, intrinsic anomalies of coronaries, anomalies of termination, and anomalous anastomotic vessels [16]. Coronary artery abnormalities are more common in patients with congenital heart disease. Even when clinically irrelevant, these lesions may become important as they may affect surgical repair. Unambiguous coronary artery imaging is therefore mandatory in this situation and, especially when echocardiography is not conclusive ,CT should be employed to avoid unnecessary invasive procedures, even in the neonatal period. The most common conditions to consider in this setting include tetralogy of Fallot and (dextro-)transposition of the great arteries[17].
- Conditions
- Cardiac Congenital Defects
- Being tested
- Cardiac CT
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CTRadiation
Computed tomography angiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of coronary arteries anomalies by computed tomography angiography in children with congenital heart disease
Delineate coronary artery anatomy and detection of coronary anomalies in children with complex cardiac anomalies by cardiac CT-angiography before total surgical correction.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cardiac Congenital DefectsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Mohamed Rashed Gad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381128
- Sponsor's protocol ID
- CAA by CT in children with CHD
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jacobs ML, Mavroudis C. Anomalies of the coronary arteries: nomenclature and classification. Cardiol Young. 2010 Dec;20 Suppl 3:15-9. doi: 10.1017/S1047951110001046.
PubMed 21087555Cheezum MK, Liberthson RR, Shah NR, Villines TC, O'Gara PT, Landzberg MJ, Blankstein R. Anomalous Aortic Origin of a Coronary Artery From the Inappropriate Sinus of Valsalva. J Am Coll Cardiol. 2017 Mar 28;69(12):1592-1608. doi: 10.1016/j.jacc.2017.01.031.
PubMed 28335843Mery CM, De Leon LE, Molossi S, Sexson-Tejtel SK, Agrawal H, Krishnamurthy R, Masand P, Qureshi AM, McKenzie ED, Fraser CD Jr. Outcomes of surgical intervention for anomalous aortic origin of a coronary artery: A large contemporary prospective cohort study. J Thorac Cardiovasc Surg. 2018 Jan;155(1):305-319.e4. doi: 10.1016/j.jtcvs.2017.08.116. Epub 2017 Sep 14.
PubMed 29074047Vastel-Amzallag C, Le Bret E, Paul JF, Lambert V, Rohnean A, El Fassy E, Sigal-Cinqualbre A. Diagnostic accuracy of dual-source multislice computed tomographic analysis for the preoperative detection of coronary artery anomalies in 100 patients with tetralogy of Fallot. J Thorac Cardiovasc Surg. 2011 Jul;142(1):120-6. doi: 10.1016/j.jtcvs.2010.11.016. Epub 2011 Feb 3.
PubMed 21292283Yu FF, Lu B, Gao Y, Hou ZH, Schoepf UJ, Spearman JV, Cao HL, Sun ML, Jiang SL. Congenital anomalies of coronary arteries in complex congenital heart disease: diagnosis and analysis with dual-source CT. J Cardiovasc Comput Tomogr. 2013 Nov-Dec;7(6):383-90. doi: 10.1016/j.jcct.2013.11.004. Epub 2013 Nov 8.
PubMed 24331934Secinaro A, Curione D, Mortensen KH, Santangelo TP, Ciancarella P, Napolitano C, Del Pasqua A, Taylor AM, Ciliberti P. Dual-source computed tomography coronary artery imaging in children. Pediatr Radiol. 2019 Dec;49(13):1823-1839. doi: 10.1007/s00247-019-04494-2. Epub 2019 Aug 22.
PubMed 31440884Frommelt P, Lopez L, Dimas VV, Eidem B, Han BK, Ko HH, Lorber R, Nii M, Printz B, Srivastava S, Valente AM, Cohen MS. Recommendations for Multimodality Assessment of Congenital Coronary Anomalies: A Guide from the American Society of Echocardiography: Developed in Collaboration with the Society for Cardiovascular Angiography and Interventions, Japanese Society of Echocardiography, and Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2020 Mar;33(3):259-294. doi: 10.1016/j.echo.2019.10.011. No abstract available.
PubMed 32143778Goo HW. Coronary artery imaging in children. Korean J Radiol. 2015 Mar-Apr;16(2):239-50. doi: 10.3348/kjr.2015.16.2.239. Epub 2015 Feb 27.
PubMed 25741188Lederlin M, Thambo JB, Latrabe V, Corneloup O, Cochet H, Montaudon M, Laurent F. Coronary imaging techniques with emphasis on CT and MRI. Pediatr Radiol. 2011 Dec;41(12):1516-25. doi: 10.1007/s00247-011-2222-0. Epub 2011 Nov 30.
PubMed 22127683Hazekamp M. Coronary Anatomy in Congenital Heart Disease: The Important Contributions of Professor Dr. Adriana Gittenberger-de Groot. J Cardiovasc Dev Dis. 2021 Mar 9;8(3):27. doi: 10.3390/jcdd8030027.
PubMed 33803117Freire G, Miller MS. Echocardiographic evaluation of coronary arteries in congenital heart disease. Cardiol Young. 2015 Dec;25(8):1504-11. doi: 10.1017/S1047951115002000.
PubMed 26675597Malone LJ, Morin CE, Browne LP. Coronary computed tomography angiography in children. Pediatr Radiol. 2022 Dec;52(13):2498-2509. doi: 10.1007/s00247-021-05209-2. Epub 2021 Nov 4.
PubMed 34734316Ezzeldin DA, Hafez MS, Mansour A. Multidetector computed tomography for patients with congenital heart disease: a multi-center registry from Africa and Middle East; patients' characteristics and procedural safety. Egypt Heart J. 2021 Oct 16;73(1):90. doi: 10.1186/s43044-021-00217-x.
PubMed 34655343Zhang LJ, Zhou CS, Wang Y, Jin Z, Yu W, Zhang Z, Zhang B, Fang X, Cui X, Li K, Huang W, Zheng L, Ji XM, Hoffman C, Schoepf UJ, Lu GM. Prevalence and types of coronary to pulmonary artery fistula in a Chinese population at dual-source CT coronary angiography. Acta Radiol. 2014 Nov;55(9):1031-9. doi: 10.1177/0284185113512299. Epub 2013 Nov 26.
PubMed 24280135Chao BT, Wang XM, Wu LB, Chen J, Cheng ZP, Wu DW, Duan YH. Diagnostic value of dual-source CT in Kawasaki disease. Chin Med J (Engl). 2010 Mar 20;123(6):670-4.
PubMed 20368084
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Coronary Arteries Anomalies by Computed Tomography Angiography in Children With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06381128
- Acronym / sponsor ID
- CAA by CT in children with CHD
- Conditions
- Cardiac Congenital Defects
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 24 Apr 2024 (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.
Delineate coronary artery anatomy and detection of coronary anomalies in children with complex cardiac anomalies by cardiac CT-angiography before total surgical correction.
Detailed description
Congenital heart diseases (CHD) form an important spectrum of pediatric diseases causing significant morbidity and mortality. Due to inter-related embryology of the heart and development of the coronary arteries, there is a great variability in coronary artery patterns in patients with CHD [1].
The spectrum of coronary artery anomalies ranges from benign / incidental findings to significant cardiac morbidity in infancy or increased risk of cardiac sudden death in childhood or adolescence [2]. Abnormalities can be found in the coronary artery origin, course, and size or the number of vessels. Isolated anomalies of coronary artery origins, in those without structural heart disease, had an estimated incidence of 0.7% [3]. Coronary artery anomalies have a higher incidence in children with congenital heart disease, ranging from an incidence of 5% in those with coarctation [4] to 7% in tetralogy of Fallot [5] and up to 37% in single-ventricle physiologies [6]. Identifying these anomalies has become an important part of the preoperative evaluation to avoid inadvertent injury and has been shown to be effectively diagnosed with modern CT techniques compared to surgical visualization and catheter angiography [6,7]. System of coronary artery origin and branching is of great help to surgeons who dedicate their efforts to the treatment of congenital heart disease [8].
Coronary artery imaging in children is frequently challenging due to small size, high heart rates, and motion artifacts from cardiac pulsation, respiration, and the patients themselves, which results in technical or procedural difficulties [9].
Imaging modalities for evaluating coronary arteries in children include echocardiography, conventional invasive angiography, magnetic resonance imaging (MRI), and computed tomography (CT). Transthoracic echocardiography is widely used as the primary imaging approach. However, it is impaired by its limited ability to fully characterize coronary anatomy, by poor acoustic windows, and by operator dependency [10].
Magnetic resonance imaging (MRI), also provides information on cardiac anatomy and function, allowing 3-dimensional coronary artery imaging without the use of ionizing radiation.However, it is impaired by long acquisition time requiring prolonged patient cooperation, which may not be possible in children without general anesthesia, and bylimited spatial resolution which makes coronary evaluation beyond originassessment difficult [11].
Computed tomography (CT) angiography is often the firstline diagnostic modality of choice for noninvasive imaging of the coronary arteries in both adults and children. CT is rapidly acquired and can be performed in the setting of multiple support devices. Compared with cardiac MRI and transthoracic echocardiography, CT provides excellent spatial resolution with superior visualization of the entire course of the coronary arteries [12].
Recent advances in CT technology have allowed for dramatic decreases in radiation dose while maintaining theexcellent spatial resolution that allows for detailed anatomical evaluation [13].
Coronary artery abnormalities in children may be congenital or acquired. Congenital anomalies include a complex group of disorders occurring as isolated conditions or in the spectrum of congenital heart disease.Acquired coronary anomalies are mainly secondary to Kawasaki disease or surgery when congenital heart disease repair involves coronary manipulation. Increasing evidence is supporting the role of CT in general for coronary evaluation of these patients [14,15]. The Coronary artery anomalies are grouped under four subtypes, i.e. anomalies of origin and course, intrinsic anomalies of coronaries, anomalies of termination, and anomalous anastomotic vessels [16]. Coronary artery abnormalities are more common in patients with congenital heart disease. Even when clinically irrelevant, these lesions may become important as they may affect surgical repair. Unambiguous coronary artery imaging is therefore mandatory in this situation and, especially when echocardiography is not conclusive ,CT should be employed to avoid unnecessary invasive procedures, even in the neonatal period. The most common conditions to consider in this setting include tetralogy of Fallot and (dextro-)transposition of the great arteries[17].
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- -Children aged from 1 day to 18 years old with congenital heart disease and undergoing surgical correction.
Key inclusion criteria (1 listed)
- Children aged from 1 day to 18 years old with congenital heart disease and undergoing surgical correction.
Key exclusion criteria (4 listed)
- 1-Children had isolated coronary anatomy anomalies.
- 2-Children had medical coronary artery disease i.e. Kawasaki disease.
- 3-Children with CHD and not candidate for surgical correction .
- 4-Children with CHD with past history of cardiac surgery.
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 |
|---|---|---|
| Cardiac CTComputed tomography angiography | Radiation | – |
Primary outcome
Detection of coronary arteries anomalies by computed tomography angiography in children with congenital heart disease
Time frame: Baseline
Delineate coronary artery anatomy and detection of coronary anomalies in children with complex cardiac anomalies by cardiac CT-angiography before total surgical correction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 21087555Jacobs ML, Mavroudis C. Anomalies of the coronary arteries: nomenclature and classification. Cardiol Young. 2010 Dec;20 Suppl 3:15-9. doi: 10.1017/S1047951110001046.
- Background: PubMed 28335843Cheezum MK, Liberthson RR, Shah NR, Villines TC, O'Gara PT, Landzberg MJ, Blankstein R. Anomalous Aortic Origin of a Coronary Artery From the Inappropriate Sinus of Valsalva. J Am Coll Cardiol. 2017 Mar 28;69(12):1592-1608. doi: 10.1016/j.jacc.2017.01.031.
- Background: PubMed 29074047Mery CM, De Leon LE, Molossi S, Sexson-Tejtel SK, Agrawal H, Krishnamurthy R, Masand P, Qureshi AM, McKenzie ED, Fraser CD Jr. Outcomes of surgical intervention for anomalous aortic origin of a coronary artery: A large contemporary prospective cohort study. J Thorac Cardiovasc Surg. 2018 Jan;155(1):305-319.e4. doi: 10.1016/j.jtcvs.2017.08.116. Epub 2017 Sep 14.
- Background: PubMed 21292283Vastel-Amzallag C, Le Bret E, Paul JF, Lambert V, Rohnean A, El Fassy E, Sigal-Cinqualbre A. Diagnostic accuracy of dual-source multislice computed tomographic analysis for the preoperative detection of coronary artery anomalies in 100 patients with tetralogy of Fallot. J Thorac Cardiovasc Surg. 2011 Jul;142(1):120-6. doi: 10.1016/j.jtcvs.2010.11.016. Epub 2011 Feb 3.
- Background: PubMed 24331934Yu FF, Lu B, Gao Y, Hou ZH, Schoepf UJ, Spearman JV, Cao HL, Sun ML, Jiang SL. Congenital anomalies of coronary arteries in complex congenital heart disease: diagnosis and analysis with dual-source CT. J Cardiovasc Comput Tomogr. 2013 Nov-Dec;7(6):383-90. doi: 10.1016/j.jcct.2013.11.004. Epub 2013 Nov 8.
- Background: PubMed 31440884Secinaro A, Curione D, Mortensen KH, Santangelo TP, Ciancarella P, Napolitano C, Del Pasqua A, Taylor AM, Ciliberti P. Dual-source computed tomography coronary artery imaging in children. Pediatr Radiol. 2019 Dec;49(13):1823-1839. doi: 10.1007/s00247-019-04494-2. Epub 2019 Aug 22.
- Background: PubMed 32143778Frommelt P, Lopez L, Dimas VV, Eidem B, Han BK, Ko HH, Lorber R, Nii M, Printz B, Srivastava S, Valente AM, Cohen MS. Recommendations for Multimodality Assessment of Congenital Coronary Anomalies: A Guide from the American Society of Echocardiography: Developed in Collaboration with the Society for Cardiovascular Angiography and Interventions, Japanese Society of Echocardiography, and Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2020 Mar;33(3):259-294. doi: 10.1016/j.echo.2019.10.011. No abstract available.
- Background: PubMed 25741188Goo HW. Coronary artery imaging in children. Korean J Radiol. 2015 Mar-Apr;16(2):239-50. doi: 10.3348/kjr.2015.16.2.239. Epub 2015 Feb 27.
- Background: PubMed 22127683Lederlin M, Thambo JB, Latrabe V, Corneloup O, Cochet H, Montaudon M, Laurent F. Coronary imaging techniques with emphasis on CT and MRI. Pediatr Radiol. 2011 Dec;41(12):1516-25. doi: 10.1007/s00247-011-2222-0. Epub 2011 Nov 30.
- Background: PubMed 33803117Hazekamp M. Coronary Anatomy in Congenital Heart Disease: The Important Contributions of Professor Dr. Adriana Gittenberger-de Groot. J Cardiovasc Dev Dis. 2021 Mar 9;8(3):27. doi: 10.3390/jcdd8030027.
- Background: PubMed 26675597Freire G, Miller MS. Echocardiographic evaluation of coronary arteries in congenital heart disease. Cardiol Young. 2015 Dec;25(8):1504-11. doi: 10.1017/S1047951115002000.
- Background: PubMed 34734316Malone LJ, Morin CE, Browne LP. Coronary computed tomography angiography in children. Pediatr Radiol. 2022 Dec;52(13):2498-2509. doi: 10.1007/s00247-021-05209-2. Epub 2021 Nov 4.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Congenital Defects, run by Assiut University.
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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rehab Mohamed Rashed, Assistant lecturer (01064959241, rehabrashed950@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of coronary arteries anomalies by computed tomography angiography in children with congenital heart disease (time frame: Baseline). 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 NCT06381128, which also lists 17 linked publications.
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 24 Apr 2024.