Determining the Natural and "Unnatural" History of Anomalous Aortic Origin of a Coronary Artery with an Interarterial or Intraconal or Intermural Course (AAOCA): Establishing a Multi-Institutional Registry

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 10-000466
    Sponsor Protocol Number: 10-000466

About this study

The purpose of the study is to determine the outcome of surgical intervention versus observation in children and young adults with AAOCA. To do this the plan is to create a registry of AAOCA subjects that will enable us to develop a risk stratification model utilizing a large multi-institutional registry under the auspices of the Congenital Heart Surgeons’ Society (CHSS).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. Diagnosis and/or management of AAOCA at a CHSS member institution from January 1, 1998 forward
  2. Male or female age 0-30 years at time of diagnosis
  3. If surgical repair:
    1. Performed from January 1, 1998 to study initiation (January 20, 2009) for retrospective subjects
    2. Performed from January 21, 2009 forward for prospectively identified subjects
    3. Completed operative note
  4. Structurally normal heart or with small, hemodynamically insignificant lesion, including:
    1. Patent ductus arteriosus 
    2. Atrial septal defect 
    3. Ventricular septal defect
    4. Mild pulmonic valvar stenosis 
    5. Bicuspid aortic valve without aortic stenosis
  5. Parental/guardian permission (informed consent, and authorization as applicable) 
  6. Subject consent, and authorization as applicable if ≥ 18 years of age and if appropriate, child assent for the observational/questionnaire portion of the study.

Exclusion Criteria:

  1. Anomalous coronary from the pulmonary artery, coronary artery atresia, or other coronary artery anomalies (e.g., coronary-cameral fistula, coronary aneurysms, myocardial bridging)
  2. Hemodynamically significant structural heart disease, except as outlined above.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Dearani, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Cori Larson CCRP

(507)255-0036

Larson.Cori@mayo.edu

.
CLS-20317675

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