Anomalous Coronary Artery Course Clinical Trial
— NARCOOfficial title:
Registry for Invasive and Non-invasive Anatomical Assessment and Outcome of Coronary Artery Anomalies
NCT number | NCT04475289 |
Other study ID # | 2020-00841 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2000 |
Est. completion date | June 30, 2030 |
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | June 30, 2030 |
Est. primary completion date | April 30, 2030 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 years. - CAA with a clinically indicated testing (noninvasive and/or invasive measurement) at our institution - Informed consent Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Inselspital, Bern | Bern | |
Switzerland | University Hospital, Zürich | Zürich |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern | University Hospital, Zürich |
Switzerland,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | 5 years | |
Secondary | 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 | Through clinically indicated diagnostic evaluation, an average of 2 months | |
Secondary | Computational fluid dynamics | The correlation between FFR-CT and the invasively measured FFR-values | Through clinically indicated diagnostic evaluation, an average of 2 months | |
Secondary | IVUS | The alternation of intravascular ultrasound (IVUS) minimum lumen area at rest and under pharmacologic inotropic stress + volume challenge | Through clinically indicated diagnostic evaluation, an average of 2 months | |
Secondary | Sports | Sports behaviour survey | at baseline, one year and 5 year after diagnosis |
Status | Clinical Trial | Phase | |
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Recruiting |
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New Patient-specific Functional Assessment of the Anomalous Aortic Origin of Coronary Arteries.
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N/A |