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

Sponsor
ITAB - Institute for Advanced Biomedical Technologies (Other)
Overall Status
Completed
CT.gov ID
NCT04224090
Collaborator
Ospedali Riuniti Ancona (Other)
4,000
1
95
42.1

Study Details

Study Description

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 Phase
  • 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

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 :
Jan 1, 2014
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. CAA [At the time of the routine echocardiography assessment]

    The number of coronary arteries anomalies echocardiographically detected

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients undergoing their first echocardiographic examination
Exclusion Criteria:
  • already known congenital heart disease and cardiomyopathies

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ospedali Riuniti Ancona Italy

Sponsors and Collaborators

  • ITAB - Institute for Advanced Biomedical Technologies
  • Ospedali Riuniti Ancona

Investigators

  • Principal Investigator: Francesco Bianco, M.D., Ospedali Riuniti

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Francesco Bianco, Researcher, ITAB - Institute for Advanced Biomedical Technologies
ClinicalTrials.gov Identifier:
NCT04224090
Other Study ID Numbers:
  • Cor001
First Posted:
Jan 13, 2020
Last Update Posted:
Jan 24, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Francesco Bianco, Researcher, ITAB - Institute for Advanced Biomedical Technologies
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 24, 2022