Clinical trial NCT04224090: Diagnostic Performance of a New Method for the Echocardiographic Assessment of Coronary Arteries Abnormalities
Official title: Diagnostic Performance of a Rational and Standardized New Method for the Echocardiographic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Anomaly
Keywords: Coronary arteries abnormalities
Coronary arteries anomaly
Coronary origin from the wrong sinus of Valsalva
Echocardiography
Lead sponsor: ITAB - Institute for Advanced Biomedical Technologies
Sponsor class: OTHER
Collaborators: name: Ospedali Riuniti Ancona
First posted: 2020-01-13
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients (neonates, pediatrics, adolescents and young adults) undergoing routine echocardiography in our department

Brief summary: Coronary artery anomalies (CAA) are a rare congenital condition, accounting abnormalities of origin, course, destination, size, and number of the coronary vessels. In normal hearts, the coronary arteries, the left and right coronary arteries (LCA and RCA, respectively) originate from the two facing aortic sinuses of Valsalva, so-called left and right. To overcome the echocardiographic limitations, the investigators designed, studied and implemented in our Institute a specific echocardiographic-based two-dimensional non-Doppler 4-views approach for the diagnosis of CAA.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients undergoing their first echocardiographic examination

Exclusion Criteria:

* already known congenital heart disease and cardiomyopathies

Primary outcomes:
measure: CAA
timeFrame: At the time of the routine echocardiography assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Ospedali Riuniti
Study officials:
affiliation: Ospedali Riuniti
name: Francesco Bianco, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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