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NCT07544979 · ClinicalTrials.gov registry record · NA
Creation of a Decision Aid for Coronary Anomalies
A NA study, sponsored by Vanderbilt University Medical Center.
- Not yet
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT07544979 is a NA study that has not yet begun recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 60 participants.
The verdict
NCT07544979, a NA study, has not yet begun recruiting, sponsored by Vanderbilt University Medical Center.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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
Interventions
- OTHER Decision aid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-07 |
| Est. Completion | 2029-03-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07544979
The ClinicalTrials.gov registry entry for NCT07544979 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Decision aid is the first listed.
NCT07544979 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07544979 about?
NCT07544979 is a clinical study titled "Creation of a Decision Aid for Coronary Anomalies". 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 origi...
What is the current status of trial NCT07544979?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2026-07. Estimated completion is 2029-03-30.
What interventions are being tested in trial NCT07544979?
The interventions under investigation include: Decision aid (OTHER).
Who is sponsoring clinical trial NCT07544979?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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