Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical study, to gather information about people with anomalous aortic origin of a coronary artery (AAOCA) for a research registry.
We hope the information collected in the registry (a place where data and records are kept and made available for research) will help us to better understand AAOCA and help improve the lives of future patients. Specifically, we want to see if there are any differences in outcome after diagnosis in children who have different types of heart operations and find which treatment options are best.
This registry is a collaboration of member institutions of the Congenital Heart Surgeons Society (CHSS).
What is the Congenital Heart Surgeons’ Society (CHSS)?
CHSS is a group of approximately 170 surgeons from 70 hospitals in the United States, Canada and South America collecting information on children with congenital heart disease. The members of this group all share a common interest in treatment and management of congenital heart malformations and are committed to research in this area.
Since children with congenital heart disease have many different and sometimes rare conditions, gathering information from many centers gives CHSS better information on how these children are doing. We also learn what factors and treatments have a better or worse result.
Where is the information collected for this registry kept?
Information collected is kept in a secure and confidential registry at the CHSS Data Center, which is at the Hospital for Sick Kids in Toronto, Ontario, Canada.
Who can participate?
Infants, children, teens and young adults who have AAOCA and were born after January 1, 1998 may be eligible for participation.
Those who have any of the following will NOT be able to participate:
- Anomalous coronary artery from the pulmonary artery, coronary artery atresia, or other coronary artery anomalies (e.g., coronary-cameral fistula, coronary aneurysms, myocardial bridging)
- Hemodynamically significant structural heart disease
What will happen in the study?
This is an observational study, and does not involve medicines. You (as a participant 18 years or older) or your child will still take medicines normally prescribed by a doctor.
There are no additional research visits or exams for this study. You/your child should continue with regularly scheduled clinical doctor’s visits. All monitoring are performed as standard of care.
We would like to follow you/your child in this study throughout your life so that we can evaluate long-term outcomes of AAOCA. By agreeing to participate in this study, you are giving permission for the study doctors to contact you or your child as mentioned below. If you are a parent, once your child is old enough to understand and participate in the consent process, we will ask if he/she is willing to continue in the study.
If you/your child decide to take part in this study, you will have your medical chart reviewed for certain information.
Information including your/your child’s name, address, and phone numbers, diagnosis, pediatrician’s name and address, medical and surgical reports, medications, and copies of echocardiograms, chest x-rays, exercise tests, nuclear medicine scans, MRI, CT scans, and cardiac catheterizations will be sent to the CHSS Data Center and entered into a password-protected computer database there. De-identified compact discs of your/your child’s echocardiograms, nuclear perfusion scan, MRI, and/or CT scans will also be securely forwarded to the Data Center.
Once this information is collected and sent to CHSS, a unique study identification number will be created for you/your child so that personal health information is not used directly in any further analysis or correspondence.
A specially trained staff member from the CHSS Data Center will call you to welcome you/your child into the study. Then, every year, a staff member will contact you to ask how you/your child is doing and ask that you fill out a short survey lasting about 10 to 15 minutes. The survey, which can be completed over the phone or through the mail, will have questions about your/your child’s health, quality of life, medications, exercise limitations, and any surgery or procedures done since the previous questionnaire.
Information from the database, calls and surveys will be analyzed together with information from other people with the same heart defect from collaborating centers. It will be used to determine the impact of patient factors and different treatments on results and to examine the overall health status of children with AAOCA.
You, as a parent/guardian or participant, will be given a consent form that thoroughly explains all the details of the study. A member of the study staff will review the consent form with you and/or your child and will be sure that all your questions are answered.
What are the good things that can happen from this research?
There is no direct benefit from participating in this study right now. However, the information collected by this study may contribute to the care of children in the future who have AAOCA.
Any significant new findings that may affect health, welfare or willingness to stay in the study will be given to you and/or your child.
What are the bad things that can happen from this research?
There are no medical harms, discomforts, or inconveniences associated with taking part in this study. If you agree to participate, or for your child to participate, your/your child’s diagnostic testing, surgery, or other interventions will not be changed in any way.
All records associated with your/your child’s participation will be kept strictly confidential within the CHSS Data Center registry and at Cincinnati Children’s. Personal health information will not be released to any outside individuals or used in any publication. It is not likely, but possible, that confidentiality may be lost in this study. We will take every reasonable precaution to avoid this from happening.
Some of the questions may make you/your child uncomfortable or cause you to remember situations that were upsetting. You/your child do not need to answer any questions you do not wish to answer and can stop the questionnaire at any time.
All possible risks will be discussed with you/your child if you are interested in learning more about the study.