NCT07544979 Creation of a Decision Aid for Coronary Anomalies
| NCT ID | NCT07544979 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | AAOCA |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-08-01 |
| Primary Completion | 2029-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-08-01 with a primary completion date of 2029-03-30.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07544979 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 35 Years, studying AAOCA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07544979 currently recruiting?
Yes, NCT07544979 is actively recruiting participants. Contact the research team at andrew.well@vumc.org for enrollment information.
Where is the NCT07544979 trial being conducted?
This trial is being conducted at Boston, United States, Philadelphia, United States, Nashville, United States, Austin, United States and 1 additional location.
Who is sponsoring the NCT07544979 clinical trial?
NCT07544979 is sponsored by Vanderbilt University Medical Center. The trial plans to enroll 60 participants.