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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Anomaly
• Intervention / Treatment: Diagnostic test: Echocardiographic assessment of coronary arteries origin and proximal course

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 Type: Observational
• Enrollment (Actual): 4000

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy
    • Ospedali Riuniti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Outpatients (neonates, pediatrics, adolescents and young adults) undergoing routine echocardiography in our department

Description

Inclusion Criteria:

• patients undergoing their first echocardiographic examination

Exclusion Criteria:

• already known congenital heart disease and cardiomyopathies

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAA	The number of coronary arteries anomalies echocardiographically detected	At the time of the routine echocardiography assessment

Collaborators and Investigators

• Sponsor: ITAB - Institute for Advanced Biomedical Technologies
• Collaborators: Ospedali Riuniti Ancona
• Investigators: Principal Investigator: Francesco Bianco, M.D., Ospedali Riuniti

Publications and helpful links

General Publications

• Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.
• Cheezum 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.
• Angelini P. Normal and anomalous coronary arteries in humans. In. Coronary artery anomalies: A comprehensive approach. Philadelphia: Lippincott Williams & Wilkins; 1999.
• Perez-Pomares JM, de la Pompa JL, Franco D, Henderson D, Ho SY, Houyel L, Kelly RG, Sedmera D, Sheppard M, Sperling S, Thiene G, van den Hoff M, Basso C. Congenital coronary artery anomalies: a bridge from embryology to anatomy and pathophysiology--a position statement of the development, anatomy, and pathology ESC Working Group. Cardiovasc Res. 2016 Feb 1;109(2):204-16. doi: 10.1093/cvr/cvv251. Epub 2016 Jan 11.
• Basso C, Maron BJ, Corrado D, Thiene G. Clinical profile of congenital coronary artery anomalies with origin from the wrong aortic sinus leading to sudden death in young competitive athletes. J Am Coll Cardiol. 2000 May;35(6):1493-501. doi: 10.1016/s0735-1097(00)00566-0.
• Maron BJ, Doerer JJ, Haas TS, Tierney DM, Mueller FO. Sudden deaths in young competitive athletes: analysis of 1866 deaths in the United States, 1980-2006. Circulation. 2009 Mar 3;119(8):1085-92. doi: 10.1161/CIRCULATIONAHA.108.804617. Epub 2009 Feb 16.
• Jureidini SB, Marino CJ, Singh GK, Balfour IC, Rao PS, Chen SC. Aberrant coronary arteries: a reliable echocardiographic screening method. J Am Soc Echocardiogr. 2003 Jul;16(7):756-63. doi: 10.1016/S0894-7317(03)00321-3.
• Brown LM, Duffy CE, Mitchell C, Young L. A practical guide to pediatric coronary artery imaging with echocardiography. J Am Soc Echocardiogr. 2015 Apr;28(4):379-91. doi: 10.1016/j.echo.2015.01.008. Epub 2015 Feb 15.
• Bianco F, Colaneri M, Bucciarelli V, Surace FC, Iezzi FV, Primavera M, Biasi A, Giusti G, Berton E, Baldoni M, Renda G, Baldinelli A, Gallina S, Pozzi M. Echocardiographic screening for the anomalous aortic origin of coronary arteries. Open Heart. 2021 Jan;8(1):e001495. doi: 10.1136/openhrt-2020-001495.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (ACTUAL): January 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Echocardiography; Coronary arteries abnormalities; Coronary arteries anomaly; Coronary origin from the wrong sinus of Valsalva
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: Cor001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No