Anomalous Coronary Artery OriginNARCONCT04475289
Registry for Invasive and Non-invasive Anatomical Assessment and Outcome of Coronary Artery Anomalies
An observational study of Anomalous Coronary Artery Origin and Anomalous Coronary Artery Course, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anomalous Coronary Artery Origin, Anomalous Coronary Artery Course, Anomalous Coronary Artery With Aortic Origin and Course Between the Great Arteries
- How many people
- 1,000 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jan 2000to 30 Jun 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years.
- CAA with a clinically indicated testing (noninvasive and/or invasive measurement) at our institution
- Informed consent
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Inselspital, Bern
Bern, 3010
Christoph Gräni, MD PhD, +41316324508, christoph.graeni@insel.ch
- Recruiting
University Hospital, Zürich
Zurich
Ronny R Büchel, Prof., +41 43 253 87 89
About this study
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.
Read the detailed description
Anomalous coronary arteries (CAA) represent a congenital disorder hallmarked by an anomalous location of the coronary ostium and/or vessel course. Based on the largest study assessing the prevalence and characteristics of CAA detected by coronary computer tomography angiography (CCTA) in Switzerland, the overall prevalence of CAA is 2.6%. However, depending of the type of CAA and its course in relation to the big vessels (aorta and pulmonary artery), not every CAA is accompanied by an increased cardiovascular risk.
Of particular interests are anomalous coronary arteries from the opposite sinus of Valsalva with an interarterial course (ACAOS-IC). Those CAAs represents a congenital disorder with an anomalous location of the coronary ostium and a course of the anomalous vessel between the aorta and the pulmonary artery. The prevalence of ACAOS-IC in the general population is around 1 % and even they are mostly clinically insignificant and remain often undetected.
However, some variants of ACAOS-IC are associated with adverse cardiac events (e.g. sudden cardiac death in young athletes). The possible presence of an intramural course, a course within the aortic wall is the primary cause for an oval proximal vessel shape and proximal vessel narrowing and is suggested to be the primary cause for ischemia. These features may lead under stress conditions to a "dynamic compression" of the vessel (compared to "fixed" stenosis in coronary artery disease). Therefore, to mimic these conditions, dobutamine and volume challenge is used to invasively measure fractional flow reserve (FFRDobutamine) during coronary angiography and is seen as the gold standard in assessing the hemodynamic relevance of ACAOS-IC. Presence of an abnormal FFRDobutamine is one of the most important factors in the decision-making towards surgical repair in ACAOS-IC.
With the frequent use of invasive and non-invasive imaging to rule out coronary artery disease, an increase in absolute numbers of ACAOS-IC is seen and physicians are more confronted with the dilemma of how to manage these patients. Usually the question is whether the ACAOS-IC is a coincidental finding or if the anomaly is causative for the patients' symptoms. Thus, systematic acquisition of all available diagnostic methods (invasive and non-invasive) is required to assess the optimal diagnostic procedure for this patients.
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (5)
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)
Measured: 5 years
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
Measured: Through clinically indicated diagnostic evaluation, an average of 2 months
Computational fluid dynamics
The correlation between FFR-CT and the invasively measured FFR-values
Measured: Through clinically indicated diagnostic evaluation, an average of 2 months
IVUS
The alternation of intravascular ultrasound (IVUS) minimum lumen area at rest and under pharmacologic inotropic stress + volume challenge
Measured: Through clinically indicated diagnostic evaluation, an average of 2 months
Sports
Sports behaviour survey
Measured: at baseline, one year and 5 year after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Jan 2000
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anomalous Coronary Artery OriginStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- Christoph Gräni, MD PhD, Principal investigator, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475289
- Sponsor's protocol ID
- 2020-00841
- Acronym
- NARCO
- Status last verified
- May 2024
- First submitted
- 10 Jul 2020
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28385257
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for Invasive and Non-invasive Anatomical Assessment and Outcome of Coronary Artery Anomalies
- ClinicalTrials.gov ID
- NCT04475289
- Acronym / sponsor ID
- NARCO / 2020-00841
- Conditions
- Anomalous Coronary Artery Origin, Anomalous Coronary Artery Course, Anomalous Coronary Artery With Aortic Origin and Course Between the Great Arteries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anomalous coronary arteries (CAA) represent a congenital disorder hallmarked by an anomalous location of the coronary ostium and/or vessel course. Based on the largest study assessing the prevalence and characteristics of CAA detected by coronary computer tomography angiography (CCTA) in Switzerland, the overall prevalence of CAA is 2.6%. However, depending of the type of CAA and its course in relation to the big vessels (aorta and pulmonary artery), not every CAA is accompanied by an increased cardiovascular risk.
Of particular interests are anomalous coronary arteries from the opposite sinus of Valsalva with an interarterial course (ACAOS-IC). Those CAAs represents a congenital disorder with an anomalous location of the coronary ostium and a course of the anomalous vessel between the aorta and the pulmonary artery. The prevalence of ACAOS-IC in the general population is around 1 % and even they are mostly clinically insignificant and remain often undetected.
However, some variants of ACAOS-IC are associated with adverse cardiac events (e.g. sudden cardiac death in young athletes). The possible presence of an intramural course, a course within the aortic wall is the primary cause for an oval proximal vessel shape and proximal vessel narrowing and is suggested to be the primary cause for ischemia. These features may lead under stress conditions to a "dynamic compression" of the vessel (compared to "fixed" stenosis in coronary artery disease). Therefore, to mimic these conditions, dobutamine and volume challenge is used to invasively measure fractional flow reserve (FFRDobutamine) during coronary angiography and is seen as the gold standard in assessing the hemodynamic relevance of ACAOS-IC. Presence of an abnormal FFRDobutamine is one of the most important factors in the decision-making towards surgical repair in ACAOS-IC.
With the frequent use of invasive and non-invasive imaging to rule out coronary artery disease, an increase in absolute numbers of ACAOS-IC is seen and physicians are more confronted with the dilemma of how to manage these patients. Usually the question is whether the ACAOS-IC is a coincidental finding or if the anomaly is causative for the patients' symptoms. Thus, systematic acquisition of all available diagnostic methods (invasive and non-invasive) is required to assess the optimal diagnostic procedure for this patients.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥18 years.
- CAA with a clinically indicated testing (noninvasive and/or invasive measurement) at our institution
- Informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of revascularization
Time frame: 5 years
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 secondary outcomes
Quantitative assessment (in SI-Units) of the anatomical features in the coronary computed tomography angiography (CCTA)
Time frame: 5 years
Invasive assessment of hemodynamic relevance
Time frame: Through clinically indicated diagnostic evaluation, an average of 2 months
Computational fluid dynamics
Time frame: Through clinically indicated diagnostic evaluation, an average of 2 months
IVUS
Time frame: Through clinically indicated diagnostic evaluation, an average of 2 months
Sports
Time frame: at baseline, one year and 5 year after diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 28385257Grani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christoph Gräni, MD PhD principal investigator
Inselspital, Bern University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anomalous Coronary Artery Origin and Anomalous Coronary Artery Course, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christoph Gräni, MD PhD (+41 31 632 4508, christoph.graeni@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of revascularization (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04475289, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.