AAOCANCT07544979
Creation of a Decision Aid for Coronary Anomalies
A study testing Decision aid in people with AAOCA, run by Vanderbilt University Medical Center at 5 sites in United States.
Trial summary
The coronary arteries supply blood to the heart muscle. Typically, the left coronary artery comes from the left side of the aorta and the right coronary artery comes from the right side. In some cases the coronary artery comes from the wrong side of the aorta. Read more about this study
- Who is it for?
- Ages 10 to 35 years
- Conditions the study is for
- AAOCA
- What is being tested?
- Decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Aug 2026to 30 Mar 2029
- Phase
- Interventional
- 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 10 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients
- English-speaking
- 10-35 years of age
- Diagnosis of R-AAOCA without evidence of myocardial ischemia
- Parents
- English-speaking
- Child 10-17 years of age
- Diagnosis of R-AAOCA without evidence of myocardial ischemia
Who cannot join
- Patients
- Other significant cardiac anomalies
- Unwilling or unable to provide consent
- Non-English Speaking Parents
- Child with other significant cardiac anomalies
- Unwilling or unable to provide consent
- Non-English Speaking
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
Dell Children's Medical Center
Austin, Texas, 78723
Alexandra Lamari-Fisher, PhD, 1-855-324-0091, andrew.well@vumc.org
- Not yet recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Jane Newburger, MD MPH, 617-355-4278, andrew.well@vumc.org
- Not yet recruiting
Texas Children's Hospital
Houston, Texas, 77030
Silvana Molossi, MD, PhD, 8773382579, andrew.well@vumc.org
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Andrew M Well, MD, MPH, MSHCT, 615-343-0042, andrew.well@vumc.org
- Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Julie Brothers, MD, 267-426-8190, andrew.well@vumc.org
About this study
Official title: Development of a Shared Decision Aid for Anomalous Aortic Origin of a Coronary Artery
The coronary arteries supply blood to the heart muscle. Typically, the left coronary artery comes from the left side of the aorta and the right coronary artery comes from the right side. In some cases the coronary artery comes from the wrong side of the aorta. This is known as anomalous aortic origin of a coronary artery (AAOCA). In AAOCA, the major concern is the risk of sudden cardiac death (SCD). The risk of is significantly higher in left AAOCA (L-AAOCA) compared to right AAOCA (R-AAOCA). With the increased risk in L-AAOCA, surgery is recommended to "normalize" the coronary artery position. R-AAOCA has a low absolute risk of SCD. But the risk is higher than the general population. Patients, families, and clinicians must weigh the risks of surgery with the risks of observation. This leads to stress and anxiety around making the management choice. There is no "right" management choice. Shared decision making (SDM) is a strategy of including patient values, preferences, and risk tolerance in medical choices. SDM is particularly useful in settings where there is no clear correct management choice. Decision aids support SDM. No decision aid exists in R-AAOCA. This proposal will create a decision aid and collect pilot data of its implementation. We hypothesize that the use of an aid in R-AAOCA will improve SDM, comfort in the choice, and quality of life. We will engage patients, families, and clinicians to understand their needs to make management choices. This will inform the development of the aid. We will gather feedback on the aid from stakeholders and will revise it. The aid will include data and methods for patients to identify their preferences. When the aid is optimized, we will run a pilot study to evaluate its impact compared to not using the aid. We will evaluate SDM, comfort in the choice made, and quality of life at that time, at 3 months and at 6 months. The pilot data will be used to inform a larger study of the aid. This proposal can be an example how to design decision aids for other congenital heart conditions. This aligns with the AHA's mission of improving lifelong health of the whole person. By improving SDM , patients can feel more confident in their choice and relieve anxiety from the diagnosis. Overall, this proposal supports a shift to patient-centered care with a focus on improving meaningful lifelong outcomes.
Read the detailed description
Anomalous aortic origin of the right coronary artery from the left sinus of Valsalva (R-AAOCA) occurs in ~0.3% of the population. Although R-AAOCA carries an increased relative risk of sudden cardiac arrest (SCA), the absolute risk of SCA is exceedingly low (~0.02% per year). Both the inability to predict who will experience SCA, and the unknown risks of cardiac surgical intervention to correct this anomaly magnify patients', families', and caregivers' anxiety in deciding on an optimal treatment strategy. Decision aids that foster shared decision-making (SDM) are valuable for helping patients decide on a treatment when no optimal option exists. SDM is a collaborative model of decision making in which patients, families, and providers partake in making joint healthcare decisions. SDM aims to promote clinician and patient/family communication by providing the best available evidence and defining the best treatment strategy for a particular patient based on their values, preferences, and risk tolerance level. Given the complexities and uncertainties in management of patients with asymptomatic R-AAOCA, the use of a decision aid may facilitate SDM and improve psychosocial outcomes. This study aims to develop and test a decision aid to foster SDM for R-AAOCA. The specific aims are to:
Aim 1: Identify the key factors affecting management decision-making for patients with R-AAOCA without evidence of myocardial ischemia, parents/caregivers, and clinicians through a qualitative needs assessment.
Aim 2: Develop a decision aid to foster SDM in determining management strategy in individuals with R-AAOCA without evidence of myocardial ischemia utilizing user co-design principles and iterative feedback from patients, parents/caregivers, and clinicians.
Aim 3: Evaluate the impact of the implementation of the decision aid on SDM, communication, decisional conflict, decisional regret, and quality of life at the time of the decision and longitudinally over the following 6 months in a pre-post implementation study design.
The proposal will result in a patient- and family-centered decision aid to support SDM in R-AAOCA without evidence of myocardial ischemia as well as pilot implementation results to guide a larger study of the aid's use and impact. The pilot data will also allow for insights into the decision making choices of families, as well as the impact the diagnosis of R-AAOCA has on individuals and families. Importantly, this project can serve
- Conditions
- AAOCA
- Being tested
- Decision aid
- Keywords
- AAOCA, Coronary Anomalies, Shared Decision Making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidOther
The decision aid will be developed as part of this study. It will consist of a patient- and family-centered design and include information desired to support shared decision-making.
| Study group | Role | What they receive |
|---|---|---|
| Right AAOCA without evidence of ischemia receiving standard of care | No intervention | This arm will receive standard of care. |
| Right AAOCA without evidence of ischemia receiving decision aid | Experimental | This arm will receive standard of care along with the decision aid Receives: Other: Decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared Decision Making Questionnaire
9-item validated measure evaluating perceptions of shared decision making.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (5)
Satisfaction with Decision Scale
Validated 6-item scale on decisional satisfaction.
Measured: Baseline, 3 months, 6 months
Decisional Conflict Scale
16-item validated scale on decisional conflict
Measured: Baseline, 3 months, 6 months
Decisional Regret Scale
5-item validates scale for decisional regret
Measured: Baseline, 3 months, 6 months
Patient Satisfaction Questionnaire Short Form
18-item validated measure on patient satisfaction
Measured: Baseline, 3 months, 6 months
PROMIS-25
Quality of life measure
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Aug 2026
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for AAOCAStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, Children's Hospital of Philadelphia, Baylor College of Medicine, Dell Medical School
- Responsible party
- Principal investigator, Andrew Well, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544979
- Sponsor's protocol ID
- 260633
- Other IDs
- 26CDA1589623
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Besenczi R, Batfai N, Jeszenszky P, Major R, Monori F, Ispany M. Large-scale simulation of traffic flow using Markov model. PLoS One. 2021 Feb 9;16(2):e0246062. doi: 10.1371/journal.pone.0246062. eCollection 2021.
PubMed 33561138Constantinescu C, Conly J, Vayalumkal J, Gilfoyle E, Oguaju C, Kassam A. A mixed-methods needs assessment for an antimicrobial stewardship curriculum in pediatrics. Antimicrob Steward Healthc Epidemiol. 2024 Feb 23;4(1):e28. doi: 10.1017/ash.2024.8. eCollection 2024.
PubMed 38415092London hospital's fifty years of health care. Nurs Stand. 1987 Nov 14;2(7):18. doi: 10.7748/ns.2.7.18.s48.
PubMed 27319864Jegatheeswaran A, Devlin PJ, Williams WG, Brothers JA, Jacobs ML, DeCampli WM, Fleishman CE, Kirklin JK, Mertens L, Mery CM, Molossi S, Caldarone CA, Aghaei N, Lorber RO, McCrindle BW. Outcomes after anomalous aortic origin of a coronary artery repair: A Congenital Heart Surgeons' Society Study. J Thorac Cardiovasc Surg. 2020 Sep;160(3):757-771.e5. doi: 10.1016/j.jtcvs.2020.01.114. Epub 2020 Apr 13.
PubMed 32800265Petek BJ, Churchill TW, Moulson N, Kliethermes SA, Baggish AL, Drezner JA, Patel MR, Ackerman MJ, Kucera KL, Siebert DM, Salerno L, Zigman Suchsland M, Asif IM, Maleszewski JJ, Harmon KG. Sudden Cardiac Death in National Collegiate Athletic Association Athletes: A 20-Year Study. Circulation. 2024 Jan 9;149(2):80-90. doi: 10.1161/CIRCULATIONAHA.123.065908. Epub 2023 Nov 13.
PubMed 37955565Basso C, Maron BJ, Corrado D, Thiene G. Clinical profile of congenital coronary artery anomalies with origin from the wrong aortic sinus leading to sudden death in young competitive athletes. J Am Coll Cardiol. 2000 May;35(6):1493-501. doi: 10.1016/s0735-1097(00)00566-0.
PubMed 10807452Stecker EC, Reinier K, Marijon E, Narayanan K, Teodorescu C, Uy-Evanado A, Gunson K, Jui J, Chugh SS. Public health burden of sudden cardiac death in the United States. Circ Arrhythm Electrophysiol. 2014 Apr;7(2):212-7. doi: 10.1161/CIRCEP.113.001034. Epub 2014 Mar 7.
PubMed 24610738Maron BJ, Doerer JJ, Haas TS, Tierney DM, Mueller FO. Sudden deaths in young competitive athletes: analysis of 1866 deaths in the United States, 1980-2006. Circulation. 2009 Mar 3;119(8):1085-92. doi: 10.1161/CIRCULATIONAHA.108.804617. Epub 2009 Feb 16.
PubMed 19221222Stallings EB, Isenburg JL, Aggarwal D, Lupo PJ, Oster ME, Shephard H, Liberman RF, Kirby RS, Nestoridi E, Hansen B, Shan X, Navarro Sanchez ML, Boyce A, Heinke D; National Birth Defects Prevention Network. Prevalence of critical congenital heart defects and selected co-occurring congenital anomalies, 2014-2018: A U.S. population-based study. Birth Defects Res. 2022 Jan 15;114(2):45-56. doi: 10.1002/bdr2.1980. Epub 2022 Jan 19.
PubMed 35048540Pelliccia A, Spataro A, Maron BJ. Prospective echocardiographic screening for coronary artery anomalies in 1,360 elite competitive athletes. Am J Cardiol. 1993 Oct 15;72(12):978-9. doi: 10.1016/0002-9149(93)91120-7. No abstract available.
PubMed 8213561Davis JA, Cecchin F, Jones TK, Portman MA. Major coronary artery anomalies in a pediatric population: incidence and clinical importance. J Am Coll Cardiol. 2001 Feb;37(2):593-7. doi: 10.1016/s0735-1097(00)01136-0.
PubMed 11216984Angelini P, Cheong BY, Lenge De Rosen VV, Lopez A, Uribe C, Masso AH, Ali SW, Davis BR, Muthupillai R, Willerson JT. High-Risk Cardiovascular Conditions in Sports-Related Sudden Death: Prevalence in 5,169 Schoolchildren Screened via Cardiac Magnetic Resonance. Tex Heart Inst J. 2018 Aug 1;45(4):205-213. doi: 10.14503/THIJ-18-6645. eCollection 2018 Aug.
PubMed 30374227Cheezum MK, Liberthson RR, Shah NR, Villines TC, O'Gara PT, Landzberg MJ, Blankstein R. Anomalous Aortic Origin of a Coronary Artery From the Inappropriate Sinus of Valsalva. J Am Coll Cardiol. 2017 Mar 28;69(12):1592-1608. doi: 10.1016/j.jacc.2017.01.031.
PubMed 28335843
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Shared Decision Aid for Anomalous Aortic Origin of a Coronary Artery
- ClinicalTrials.gov ID
- NCT07544979
- Acronym / sponsor ID
- 260633
- Conditions
- AAOCA
- Keywords
- AAOCA, Coronary Anomalies, Shared Decision Making
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, Children's Hospital of Philadelphia, Baylor College of Medicine, Dell Medical School
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 22 Apr 2026 (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.
The coronary arteries supply blood to the heart muscle. Typically, the left coronary artery comes from the left side of the aorta and the right coronary artery comes from the right side. In some cases the coronary artery comes from the wrong side of the aorta. This is known as anomalous aortic origin of a coronary artery (AAOCA). In AAOCA, the major concern is the risk of sudden cardiac death (SCD). The risk of is significantly higher in left AAOCA (L-AAOCA) compared to right AAOCA (R-AAOCA). With the increased risk in L-AAOCA, surgery is recommended to "normalize" the coronary artery position. R-AAOCA has a low absolute risk of SCD. But the risk is higher than the general population. Patients, families, and clinicians must weigh the risks of surgery with the risks of observation. This leads to stress and anxiety around making the management choice. There is no "right" management choice. Shared decision making (SDM) is a strategy of including patient values, preferences, and risk tolerance in medical choices. SDM is particularly useful in settings where there is no clear correct management choice. Decision aids support SDM. No decision aid exists in R-AAOCA. This proposal will create a decision aid and collect pilot data of its implementation. We hypothesize that the use of an aid in R-AAOCA will improve SDM, comfort in the choice, and quality of life. We will engage patients, families, and clinicians to understand their needs to make management choices. This will inform the development of the aid. We will gather feedback on the aid from stakeholders and will revise it. The aid will include data and methods for patients to identify their preferences. When the aid is optimized, we will run a pilot study to evaluate its impact compared to not using the aid. We will evaluate SDM, comfort in the choice made, and quality of life at that time, at 3 months and at 6 months. The pilot data will be used to inform a larger study of the aid. This proposal can be an example how to design decision aids for other congenital heart conditions. This aligns with the AHA's mission of improving lifelong health of the whole person. By improving SDM , patients can feel more confident in their choice and relieve anxiety from the diagnosis. Overall, this proposal supports a shift to patient-centered care with a focus on improving meaningful lifelong outcomes.
Detailed description
Anomalous aortic origin of the right coronary artery from the left sinus of Valsalva (R-AAOCA) occurs in ~0.3% of the population. Although R-AAOCA carries an increased relative risk of sudden cardiac arrest (SCA), the absolute risk of SCA is exceedingly low (~0.02% per year). Both the inability to predict who will experience SCA, and the unknown risks of cardiac surgical intervention to correct this anomaly magnify patients', families', and caregivers' anxiety in deciding on an optimal treatment strategy. Decision aids that foster shared decision-making (SDM) are valuable for helping patients decide on a treatment when no optimal option exists. SDM is a collaborative model of decision making in which patients, families, and providers partake in making joint healthcare decisions. SDM aims to promote clinician and patient/family communication by providing the best available evidence and defining the best treatment strategy for a particular patient based on their values, preferences, and risk tolerance level. Given the complexities and uncertainties in management of patients with asymptomatic R-AAOCA, the use of a decision aid may facilitate SDM and improve psychosocial outcomes. This study aims to develop and test a decision aid to foster SDM for R-AAOCA. The specific aims are to:
Aim 1: Identify the key factors affecting management decision-making for patients with R-AAOCA without evidence of myocardial ischemia, parents/caregivers, and clinicians through a qualitative needs assessment.
Aim 2: Develop a decision aid to foster SDM in determining management strategy in individuals with R-AAOCA without evidence of myocardial ischemia utilizing user co-design principles and iterative feedback from patients, parents/caregivers, and clinicians.
Aim 3: Evaluate the impact of the implementation of the decision aid on SDM, communication, decisional conflict, decisional regret, and quality of life at the time of the decision and longitudinally over the following 6 months in a pre-post implementation study design.
The proposal will result in a patient- and family-centered decision aid to support SDM in R-AAOCA without evidence of myocardial ischemia as well as pilot implementation results to guide a larger study of the aid's use and impact. The pilot data will also allow for insights into the decision making choices of families, as well as the impact the diagnosis of R-AAOCA has on individuals and families. Importantly, this project can serve
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right AAOCA without evidence of ischemia receiving standard of care | No intervention | –This arm will receive standard of care. |
| Right AAOCA without evidence of ischemia receiving decision aid | Experimental | Other: Decision aidThis arm will receive standard of care along with the decision aid |
Who may qualify
- Ages
- 10 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patients
- Parents
- English-speaking
- Child 10-17 years of age
- Diagnosis of R-AAOCA without evidence of myocardial ischemia
Key exclusion criteria (7 listed)
- Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aidThe decision aid will be developed as part of this study. It will consist of a patient- and family-centered design and include information desired to support shared decision-making. | Other | Right AAOCA without evidence of ischemia receiving decision aid |
Primary outcome
Shared Decision Making Questionnaire
Time frame: Baseline, 3 months, 6 months
9-item validated measure evaluating perceptions of shared decision making.
5 secondary outcomes
Satisfaction with Decision Scale
Time frame: Baseline, 3 months, 6 months
Decisional Conflict Scale
Time frame: Baseline, 3 months, 6 months
Decisional Regret Scale
Time frame: Baseline, 3 months, 6 months
Patient Satisfaction Questionnaire Short Form
Time frame: Baseline, 3 months, 6 months
PROMIS-25
Time frame: Baseline, 3 months, 6 months
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 11 Aug 2026.
- Background: PubMed 33561138Besenczi R, Batfai N, Jeszenszky P, Major R, Monori F, Ispany M. Large-scale simulation of traffic flow using Markov model. PLoS One. 2021 Feb 9;16(2):e0246062. doi: 10.1371/journal.pone.0246062. eCollection 2021.
- Background: PubMed 38415092Constantinescu C, Conly J, Vayalumkal J, Gilfoyle E, Oguaju C, Kassam A. A mixed-methods needs assessment for an antimicrobial stewardship curriculum in pediatrics. Antimicrob Steward Healthc Epidemiol. 2024 Feb 23;4(1):e28. doi: 10.1017/ash.2024.8. eCollection 2024.
- Background: PubMed 27319864London hospital's fifty years of health care. Nurs Stand. 1987 Nov 14;2(7):18. doi: 10.7748/ns.2.7.18.s48.
- Background: PubMed 32800265Jegatheeswaran A, Devlin PJ, Williams WG, Brothers JA, Jacobs ML, DeCampli WM, Fleishman CE, Kirklin JK, Mertens L, Mery CM, Molossi S, Caldarone CA, Aghaei N, Lorber RO, McCrindle BW. Outcomes after anomalous aortic origin of a coronary artery repair: A Congenital Heart Surgeons' Society Study. J Thorac Cardiovasc Surg. 2020 Sep;160(3):757-771.e5. doi: 10.1016/j.jtcvs.2020.01.114. Epub 2020 Apr 13.
- Background: PubMed 37955565Petek BJ, Churchill TW, Moulson N, Kliethermes SA, Baggish AL, Drezner JA, Patel MR, Ackerman MJ, Kucera KL, Siebert DM, Salerno L, Zigman Suchsland M, Asif IM, Maleszewski JJ, Harmon KG. Sudden Cardiac Death in National Collegiate Athletic Association Athletes: A 20-Year Study. Circulation. 2024 Jan 9;149(2):80-90. doi: 10.1161/CIRCULATIONAHA.123.065908. Epub 2023 Nov 13.
- Background: PubMed 10807452Basso C, Maron BJ, Corrado D, Thiene G. Clinical profile of congenital coronary artery anomalies with origin from the wrong aortic sinus leading to sudden death in young competitive athletes. J Am Coll Cardiol. 2000 May;35(6):1493-501. doi: 10.1016/s0735-1097(00)00566-0.
- Background: PubMed 24610738Stecker EC, Reinier K, Marijon E, Narayanan K, Teodorescu C, Uy-Evanado A, Gunson K, Jui J, Chugh SS. Public health burden of sudden cardiac death in the United States. Circ Arrhythm Electrophysiol. 2014 Apr;7(2):212-7. doi: 10.1161/CIRCEP.113.001034. Epub 2014 Mar 7.
- Background: PubMed 19221222Maron BJ, Doerer JJ, Haas TS, Tierney DM, Mueller FO. Sudden deaths in young competitive athletes: analysis of 1866 deaths in the United States, 1980-2006. Circulation. 2009 Mar 3;119(8):1085-92. doi: 10.1161/CIRCULATIONAHA.108.804617. Epub 2009 Feb 16.
- Background: PubMed 35048540Stallings EB, Isenburg JL, Aggarwal D, Lupo PJ, Oster ME, Shephard H, Liberman RF, Kirby RS, Nestoridi E, Hansen B, Shan X, Navarro Sanchez ML, Boyce A, Heinke D; National Birth Defects Prevention Network. Prevalence of critical congenital heart defects and selected co-occurring congenital anomalies, 2014-2018: A U.S. population-based study. Birth Defects Res. 2022 Jan 15;114(2):45-56. doi: 10.1002/bdr2.1980. Epub 2022 Jan 19.
- Background: PubMed 8213561Pelliccia A, Spataro A, Maron BJ. Prospective echocardiographic screening for coronary artery anomalies in 1,360 elite competitive athletes. Am J Cardiol. 1993 Oct 15;72(12):978-9. doi: 10.1016/0002-9149(93)91120-7. No abstract available.
- Background: PubMed 11216984Davis JA, Cecchin F, Jones TK, Portman MA. Major coronary artery anomalies in a pediatric population: incidence and clinical importance. J Am Coll Cardiol. 2001 Feb;37(2):593-7. doi: 10.1016/s0735-1097(00)01136-0.
- Background: PubMed 30374227Angelini P, Cheong BY, Lenge De Rosen VV, Lopez A, Uribe C, Masso AH, Ali SW, Davis BR, Muthupillai R, Willerson JT. High-Risk Cardiovascular Conditions in Sports-Related Sudden Death: Prevalence in 5,169 Schoolchildren Screened via Cardiac Magnetic Resonance. Tex Heart Inst J. 2018 Aug 1;45(4):205-213. doi: 10.14503/THIJ-18-6645. eCollection 2018 Aug.
- Individual participant dataSharing planned: Yes
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with AAOCA, run by Vanderbilt University Medical Center at 5 sites in United States.
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 8 inclusion and 7 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 Andrew M Well, MD, MPH, MSHCT (615-343-0042, andrew.well@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared Decision Making Questionnaire (time frame: Baseline, 3 months, 6 months). 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 NCT07544979, which also lists 13 linked publications.
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 11 Aug 2026.