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

NCT ID: NCT04224090

Last Updated: 2022-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2021-12-01

Brief Summary

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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

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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.

Conditions

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Coronary Artery Anomaly

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Echocardiographic assessment of coronary arteries origin and proximal course

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients undergoing their first echocardiographic examination

Exclusion Criteria

* already known congenital heart disease and cardiomyopathies
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedali Riuniti Ancona

OTHER

Sponsor Role collaborator

ITAB - Institute for Advanced Biomedical Technologies

OTHER

Sponsor Role lead

Responsible Party

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Francesco Bianco

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco Bianco, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ospedali Riuniti

Locations

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Ospedali Riuniti

Ancona, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 28335843 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 26811390 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10807452 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19221222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25559473 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12835663 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25691000 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33431619 (View on PubMed)

Other Identifiers

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Cor001

Identifier Type: -

Identifier Source: org_study_id

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