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Registry for Invasive and Non-invasive Anatomical Assessment and Outcome of Coronary Artery Anomalies

NCT04475289 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-05-14

No results posted yet for this study

Summary

An anomalous coronary artery from the opposite sinus of Valsalva (ACAOS) represents a congenital disorder with an anomalous location and/or course of the coronary vessel. The prevalence of ACAOS in the general population is around 1 % and they are mostly clinically insignificant and remain often undetected. However, some variants of ACAOS are associated with adverse cardiac events. The possible presence of an interarterial/intramural course is the primary cause for an oval proximal vessel shape and/or proximal vessel narrowing, which may lead under stress conditions to a "dynamic compression" of the vessel (compared to "fixed" stenosis in coronary artery disease). To mimic these conditions, dobutamine and volume challenge is used to invasively measure fractional flow reserve (FFR) during coronary angiography and is seen as the gold standard in assessing the hemodynamic relevance of ACAOS. We established a specialized interdisciplinary clinic for coronary artery anomalies including imaging specialists, invasive cardiologists and congenital heart disease surgeons as correct downstream testing and treatment decision is highly challenging in these patients. Thus, systematic collecting of all available diagnostic methods (invasive and non-invasive) is required to assess the optimal diagnostic procedure and treatment for these patients. Coronary computed tomography angiography (CCTA) is the method of choice to characterize the exact anatomy of ACAOS. However, how functional invasive FFR is associated with anatomical CCTA findings is unknown. Further, diagnostic accuracy of a novel independent research algorithm with computational fluid dynamics (ctFFR) as well as functional imaging (i.e. stress single photon emission computed tomography) in this specific setting is unknown.

The presented project will help to understand the pathophysiology of CAAs with particular focus on ACAOS-IC and improve risk stratification based on non-invasive imaging.

Conditions

  • Anomalous Coronary Artery Origin
  • Anomalous Coronary Artery Course
  • Anomalous Coronary Artery With Aortic Origin and Course Between the Great Arteries

Sponsors & Collaborators

  • University Hospital, Zürich

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Christoph Gräni, MD PhD · Inselspital, Bern University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-01-01
Primary Completion
2030-04-30
Completion
2030-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04475289 on ClinicalTrials.gov