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

Coronary Artery Anomaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224090
• Other study ID #: Cor001
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2022
• Source: ITAB - Institute for Advanced Biomedical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients undergoing their first echocardiographic examination

Exclusion Criteria:

• already known congenital heart disease and cardiomyopathies

Related Conditions & MeSH terms

• Congenital Abnormalities
• Coronary Artery Anomaly

Intervention

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.

Locations

Country	Name	City	State
Italy	Ospedali Riuniti	Ancona

Sponsors (2)

Lead Sponsor	Collaborator
ITAB - Institute for Advanced Biomedical Technologies	Ospedali Riuniti Ancona

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Angelini P. Normal and anomalous coronary arteries in humans. In. Coronary artery anomalies: A comprehensive approach. Philadelphia: Lippincott Williams & Wilkins; 1999.

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Pérez-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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAA	The number of coronary arteries anomalies echocardiographically detected	At the time of the routine echocardiography assessment