Diagnostic Performance of a New Method for the Echocardiographic Assessment of Coronary Arteries Abnormalities
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|ClinicalTrials.gov Identifier: NCT04224090|
Recruitment Status : Completed
First Posted : January 13, 2020
Last Update Posted : January 24, 2022
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|Condition or disease||Intervention/treatment|
|Coronary Artery Anomaly||Diagnostic Test: Echocardiographic assessment of coronary arteries origin and proximal course|
The method consisted of 4-CAA-focused specific views, routinely available from any echocardiographic exam: parasternal short-axis (PSAX), parasternal long-axis (PLAX), apical 4/5-chambers views. PSAX, the traditional approach, along with the PLAX, and the apical 4/5-chambers views.
A hallmark of CAA was considered the absence of a proper visualization of the origin of the coronary arteries from the aortic root. In addition, the presence of the ring sign, visualized from the PLAX was considered as abnormal. This sign is of interest when an aberrant left or right CAA is suspected. A coronary artery originating from the contralateral aortic sinus, along its intramural course, crosses the mid-anterior line of the circular aorta to reach the sinus of Valsalva of its intended origin. Consequently, its cross-section should be visible in an orthogonal view traversing the mid-long axis of the aorta, namely the parasternal long-axis view.
|Study Type :||Observational|
|Actual Enrollment :||4000 participants|
|Official Title:||Diagnostic Performance of a Rational and Standardized New Method for the Echocardiographic|
|Actual Study Start Date :||January 1, 2014|
|Actual Primary Completion Date :||December 1, 2020|
|Actual Study Completion Date :||December 1, 2021|
Congenita coronary abnormalities (CAA)
All the coronary arteries were differing from the definition of "normal": when do not arise from the appropriate sinus of Valsalva (right or left) and not present a proper course and termination.
Diagnostic Test: Echocardiographic assessment of coronary arteries origin and proximal course
Echocardiographic assessment of CAA utilizing 4 specific echocardiographic acoustic windows: parasternal short-axis (PSAX), parasternal long-axis (PLAX), apical 4/5-chambers views.
- CAA [ Time Frame: At the time of the routine echocardiography assessment ]The number of coronary arteries anomalies echocardiographically detected
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- patients undergoing their first echocardiographic examination
- already known congenital heart disease and cardiomyopathies
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): NCT04224090
|Principal Investigator:||Francesco Bianco, M.D.||Ospedali Riuniti|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Francesco Bianco, Researcher, ITAB - Institute for Advanced Biomedical Technologies|
|Other Study ID Numbers:||
|First Posted:||January 13, 2020 Key Record Dates|
|Last Update Posted:||January 24, 2022|
|Last Verified:||January 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Coronary arteries abnormalities
Coronary arteries anomaly
Coronary origin from the wrong sinus of Valsalva