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Clinical Trials/NCT04224090
NCT04224090
Completed
Not Applicable

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

ITAB - Institute for Advanced Biomedical Technologies1 site in 1 country4,000 target enrollmentJanuary 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Anomaly
Sponsor
ITAB - Institute for Advanced Biomedical Technologies
Enrollment
4000
Locations
1
Primary Endpoint
CAA
Status
Completed
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2014
End Date
December 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
ITAB - Institute for Advanced Biomedical Technologies
Responsible Party
Principal Investigator
Principal Investigator

Francesco Bianco

Researcher

ITAB - Institute for Advanced Biomedical Technologies

Eligibility Criteria

Inclusion Criteria

  • patients undergoing their first echocardiographic examination

Exclusion Criteria

  • already known congenital heart disease and cardiomyopathies

Outcomes

Primary Outcomes

CAA

Time Frame: At the time of the routine echocardiography assessment

The number of coronary arteries anomalies echocardiographically detected

Study Sites (1)

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