Clinical Trials / Research Studies

Clinical Trials / Research Studies

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 is 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 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.