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

NCT04475289 | Recruiting

• 1 other identifier: 2020-00841
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

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.

  5 years

Secondary Outcomes (5)

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

  5 years

• Invasive assessment of hemodynamic relevance

  Through clinically indicated diagnostic evaluation, an average of 2 months

• Computational fluid dynamics

  Through clinically indicated diagnostic evaluation, an average of 2 months

• IVUS

  Through clinically indicated diagnostic evaluation, an average of 2 months

• Sports

  at baseline, one year and 5 year after diagnosis

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Age ≥18 years.
• CAA with a clinically indicated testing (noninvasive and/or invasive measurement) at our institution
• Informed consent

You may not qualify if:

• \- None

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University Hospital, Zürich: collaborator

Study Sites (2)

University Hospital Inselspital, Bern

Bern, 3010, Switzerland

RECRUITING

University Hospital, Zürich

Zurich, Switzerland

RECRUITING

Related Publications (1)

• Grani C, Buechel RR, Kaufmann PA, Kwong RY. Multimodality Imaging in Individuals With Anomalous Coronary Arteries. JACC Cardiovasc Imaging. 2017 Apr;10(4):471-481. doi: 10.1016/j.jcmg.2017.02.004.

  PMID: 28385257 BACKGROUND

Study Officials

• Christoph Gräni, MD PhD

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Gräni, MD PhD

CONTACT

+41 31 632 4508; christoph.graeni@insel.ch

Marius R Bigler, MD

CONTACT

+41 31 632 8030; mariusreto.bigler@insel.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 17, 2020
• Study Start: January 1, 2000
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

CH (2)