Creation of a Decision Aid for Coronary Anomalies

NCT07544979 | Not Yet Recruiting

• 2 other identifiers: 0519880026CDA1589623
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

AAOCA

Keywords

AAOCA; Coronary Anomalies; Shared Decision Making

Outcome Measures

Primary Outcomes (1)

• Shared Decision Making Questionnaire

  9-item validated measure evaluating perceptions of shared decision making.

  Baseline, 3 months, 6 months

Secondary Outcomes (5)

• Satisfaction with Decision Scale

  Baseline, 3 months, 6 months

• Decisional Conflict Scale

  Baseline, 3 months, 6 months

• Decisional Regret Scale

  Baseline, 3 months, 6 months

• Patient Satisfaction Questionnaire Short Form

  Baseline, 3 months, 6 months

• PROMIS-25

  Baseline, 3 months, 6 months

Study Arms (2)

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

Other: Decision aid

Interventions

Decision aid OTHER

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.

Right AAOCA without evidence of ischemia receiving decision aid

Eligibility Criteria

• Age: 10 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients
• English-speaking
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Boston Children's Hospital: collaborator
• Baylor College of Medicine: collaborator
• Dell Medical School: collaborator
• Children's Hospital of Philadelphia: collaborator

Study Sites (5)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Dell Children's Medical Center

Austin, Texas, 78723, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (13)

• 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.

  PMID: 33561138 BACKGROUND

• Constantinescu 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.

  PMID: 38415092 BACKGROUND

• London hospital's fifty years of health care. Nurs Stand. 1987 Nov 14;2(7):18. doi: 10.7748/ns.2.7.18.s48.

  PMID: 27319864 BACKGROUND

• Jegatheeswaran 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.

  PMID: 32800265 BACKGROUND

• Petek 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.

  PMID: 37955565 BACKGROUND

• Basso 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.

  PMID: 10807452 BACKGROUND

• Stecker 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.

  PMID: 24610738 BACKGROUND

• Maron 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.

  PMID: 19221222 BACKGROUND

• Stallings 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.

  PMID: 35048540 BACKGROUND

• Pelliccia 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.

  PMID: 8213561 BACKGROUND

• Davis 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.

  PMID: 11216984 BACKGROUND

• Angelini 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.

  PMID: 30374227 BACKGROUND

• Cheezum 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.

  PMID: 28335843 BACKGROUND

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Andrew M Well, MD, MPH, MSHCT

CONTACT

615-343-0042; andrew.well@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (5)