NCT04475289 Registry for Invasive and Non-invasive Anatomical Assessment and Outcome of Coronary Artery Anomalies
| NCT ID | NCT04475289 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Anomalous Coronary Artery Origin |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2000-01-01 |
| Primary Completion | 2030-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2000-01-01 with a primary completion date of 2030-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years. * CAA with a clinically indicated testing (noninvasive and/or invasive measurement) at our institution * Informed consent Exclusion Criteria: \- None
Contact & Investigator
Christoph Gräni, MD PhD
PRINCIPAL INVESTIGATOR
Inselspital, Bern University Hospital
Frequently Asked Questions
Who can join the NCT04475289 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anomalous Coronary Artery Origin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04475289 currently recruiting?
Yes, NCT04475289 is actively recruiting participants. Contact the research team at christoph.graeni@insel.ch for enrollment information.
Where is the NCT04475289 trial being conducted?
This trial is being conducted at Bern, Switzerland, Zurich, Switzerland.
Who is sponsoring the NCT04475289 clinical trial?
NCT04475289 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Christoph Gräni, MD PhD at Inselspital, Bern University Hospital. The trial plans to enroll 1,000 participants.