Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT04475289

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

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-05-14

1000

Participants Needed

2

Research Sites

1591 weeks

Total Duration

On this page

Sponsors

I

Insel Gruppe AG, University Hospital Bern

Lead Sponsor

U

University Hospital, Zürich

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6518 years.
  • Diagnosed with a coronary artery anomaly requiring testing at the study center
  • Provided informed consent to participate
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University Hospital Inselspital, Bern

Bern, Switzerland, 3010

Actively Recruiting

2

University Hospital, Zürich

Zurich, Switzerland

Actively Recruiting

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Research Team

C

Christoph Gräni, MD PhD

CONTACT

M

Marius R Bigler, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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