Diagnostic Performance of a New Method for the Echocardiographic Assessment of Coronary Arteries Abnormalities

Completed

• Conditions: Coronary Artery Anomaly
• Interventions: Diagnostic Test: Echocardiographic assessment of coronary arteries origin and proximal course

• Registration Number: NCT04224090
• Lead Sponsor: ITAB - Institute for Advanced Biomedical Technologies

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.

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Primary Completion: 2020-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• patients undergoing their first echocardiographic examination

Exclusion Criteria

• already known congenital heart disease and cardiomyopathies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Congenita coronary abnormalities (CAA)	Echocardiographic assessment of coronary arteries origin and proximal course	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.

Primary Outcome Measures

Name	Time	Method
CAA	At the time of the routine echocardiography assessment	The number of coronary arteries anomalies echocardiographically detected

Trial Locations

Locations (1)

Ospedali Riuniti; 🇮🇹 Ancona, Italy