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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥18 years.

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

Informed consent

Disqualifiers

None

Trial population

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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Patients with an coronary artery anomaly (focus on ACAOS)

Trial outcomes

Primary outcomes

1

Frequency of revascularization

Frequency of revascularizations (i.e. unroofing, re-implantation of the coronary artery, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) etc.) of the anomalous vessel in patients with CAA.

Time frame
5 years

Secondary outcomes

1

Quantitative assessment (in SI-Units) of the anatomical features in the coronary computed tomography angiography (CCTA)

The correlation between anatomical features in the CCTA and the primary outcome (frequency of revascularization)

Time frame
5 years
2

Invasive assessment of hemodynamic relevance

The correlation of invasive assessement under pharmacologic inotropic stress and volume challenge (intravascular ultrasound and fractional flow reserve) with the quantitative determined anatomical features assessed in the CCTA

Time frame
Through clinically indicated diagnostic evaluation, an average of 2 months
3

Computational fluid dynamics

The correlation between FFR-CT and the invasively measured FFR-values

Time frame
Through clinically indicated diagnostic evaluation, an average of 2 months
4

IVUS

The alternation of intravascular ultrasound (IVUS) minimum lumen area at rest and under pharmacologic inotropic stress + volume challenge

Time frame
Through clinically indicated diagnostic evaluation, an average of 2 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insel Gruppe AG, University Hospital Bern

Lead sponsor

University Hospital, Zürich

Collaborator