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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Age ≥18 years.

• CAA with a clinically indicated testing (noninvasive and/or invasive measurement) at our institution

• Informed consent

Locations
Other Locations
Switzerland
University Hospital Inselspital, Bern
RECRUITING
Bern
University Hospital, Zürich
RECRUITING
Zurich
Contact Information
Primary
Christoph Gräni, MD PhD
christoph.graeni@insel.ch
+41 31 632 4508
Backup
Marius R Bigler, MD
mariusreto.bigler@insel.ch
+41 31 632 8030
Time Frame
Start Date: 2000-01-01
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 1000
Treatments
Patients with an coronary artery anomaly (focus on ACAOS)
Patients eligible for study participation have a CAA and a prior, clinically indicated testing (noninvasive and/or invasive measurement) at our institution to evaluate the hemodynamic significance of this coronary anomaly. They will be approach either after start of this study (retrospective inclusion) or before their testing (prospective inclusion).
Related Therapeutic Areas
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern
Collaborators: University Hospital, Zürich

This content was sourced from clinicaltrials.gov