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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04224090
Recruitment Status : Completed
First Posted : January 13, 2020
Last Update Posted : January 24, 2022
Sponsor:
Collaborator:
Ospedali Riuniti Ancona
Information provided by (Responsible Party):
Francesco Bianco, ITAB - Institute for Advanced Biomedical Technologies

Study Description
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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.

Condition or disease Intervention/treatment
Coronary Artery Anomaly 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 Design
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Study Type : Observational
Actual Enrollment : 4000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Diagnostic Performance of a Rational and Standardized New Method for the Echocardiographic
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 1, 2021
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. CAA [ Time Frame: At the time of the routine echocardiography assessment ]
    The number of coronary arteries anomalies echocardiographically detected


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients (neonates, pediatrics, adolescents and young adults) undergoing routine echocardiography in our department
Criteria

Inclusion Criteria:

  • patients undergoing their first echocardiographic examination

Exclusion Criteria:

  • already known congenital heart disease and cardiomyopathies
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04224090


Locations
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Italy
Ospedali Riuniti
Ancona, Italy
Sponsors and Collaborators
ITAB - Institute for Advanced Biomedical Technologies
Ospedali Riuniti Ancona
Investigators
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Principal Investigator: Francesco Bianco, M.D. Ospedali Riuniti
More Information
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Publications:
Angelini P. Normal and anomalous coronary arteries in humans. In. Coronary artery anomalies: A comprehensive approach. Philadelphia: Lippincott Williams & Wilkins; 1999.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Francesco Bianco, Researcher, ITAB - Institute for Advanced Biomedical Technologies
ClinicalTrials.gov Identifier: NCT04224090    
Other Study ID Numbers: Cor001
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 24, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesco Bianco, ITAB - Institute for Advanced Biomedical Technologies:
Coronary arteries abnormalities
Coronary arteries anomaly
Coronary origin from the wrong sinus of Valsalva
Echocardiography
Additional relevant MeSH terms:
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Congenital Abnormalities