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

NCT04224090 | Completed DMC

• 1 other identifier: Cor001
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Anomaly

Keywords

Coronary arteries abnormalities; Coronary arteries anomaly; Coronary origin from the wrong sinus of Valsalva; Echocardiography

Outcome Measures

Primary Outcomes (1)

• CAA

  The number of coronary arteries anomalies echocardiographically detected

  At the time of the routine echocardiography assessment

Study Arms (1)

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

Interventions

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.

Congenita coronary abnormalities (CAA)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• patients undergoing their first echocardiographic examination

You may not qualify if:

• already known congenital heart disease and cardiomyopathies

Sponsors & Collaborators

• ITAB - Institute for Advanced Biomedical Technologies: lead
• Ospedali Riuniti Ancona: collaborator

Study Sites (1)

Ospedali Riuniti

Ancona, Italy

Location

Related Publications (9)

• 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.

  PMID: 28335843 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 26811390 BACKGROUND

• 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.

  PMID: 10807452 BACKGROUND

• 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.

  PMID: 19221222 BACKGROUND

• 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.

  PMID: 25559473 BACKGROUND

• 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.

  PMID: 12835663 BACKGROUND

• 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.

  PMID: 25691000 BACKGROUND

• 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.

  PMID: 33431619 DERIVED

Study Officials

• Francesco Bianco, M.D.

  Ospedali Riuniti

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: January 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)