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Completed

NCT Number: NCT04224090

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

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.

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Key information

Conditions

Coronary Artery Anomaly

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedali Riuniti

Ancona, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing their first echocardiographic examination

Exclusion criteria

  • already known congenital heart disease and cardiomyopathies

Treatment and study plan

Echocardiographic assessment of coronary arteries origin and proximal course

Diagnostic Test

Echocardiographic assessment of CAA utilizing 4 specific echocardiographic acoustic windows: parasternal short-axis (PSAX), parasternal long-axis (PLAX), apical 4/5-chambers views.

Primary outcomes

  1. CAA

    Time frame: At the time of the routine echocardiography assessment

    The number of coronary arteries anomalies echocardiographically detected

Sponsors and collaborators

Lead sponsor

ITAB - Institute for Advanced Biomedical Technologies

Other

Collaborators

  • Ospedali Riuniti Ancona

Registry information

Official study title

Diagnostic Performance of a Rational and Standardized New Method for the Echocardiographic

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
Jan 13, 2020
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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