Join the Takotsubo Syndrome Registry

Questions? Contact us at BrokenHeartStudy@NYULangone.org

NYU IRB 09-0746

Step 1: Read the Following Consent Carefully

The purpose of this research study is to learn more about a heart condition called takotsubo syndrome. This problem also goes by several other names, including takotsubo cardiomyopathy, broken heart syndrome or stress cardiomyopathy. We would like to learn whether patients who have had takotsubo syndrome have been hospitalized for heart problems again, and would like to learn about quality of life in patients who have had takotsubo syndrome.

If you decide to participate, we will take your contact information and will ask you to sign a form allowing us to access your medical records, now and in the future. We will ask you questions about your heart event and your medical history. We will ask you questions about how you view your health and your stress levels ("quality of life"). We will also record information about the time you had takotsubo syndrome, including review of any imaging tests you have already had done, from your hospital and office charts. We will also record information about your treatment since that time. All information will be strictly confidential and will be kept under electronic or physical lock. After the initial set of questions, we will contact you approximately every six months, electronically or by telephone, to ask you about any hospitalizations or new medical problems. We will ask you the quality of life questions at each visit. We will collect your medical records as needed to confirm whether you had takotsubo syndrome or another heart event, or what else may have happened to you. We will also ask you about the medications you take. We will get images from your healthcare providers, if new cardiac tests have been performed.

We are also developing research studies for the future to learn more about this problem. If it is OK with you, we would like to keep your name, telephone number and email address on a list so that we can contact you later and tell you about any research projects you might be interested in. Then if you are interested, you could decide to take part in that research study, or not, as you choose.

Step 2: Learn About Your Rights as a Study Participant

There is no expected risk to you for taking part in this study. There are no expected alternatives or benefits to you either. We estimate that approximately 500 patients will enroll in this study. There will be no way to identify you in any report of this research. Your participation is completely voluntary and you can stop participating at any time. You will need to contact the doctor in charge of the study to withdraw from the study.

To do this research, we need to collect health information that identifies you including information from your medical record. We will only collect information that is needed for the research. For you to be in this research, we will need your permission to collect this information. We will protect the information and keep it confidential. To participate in the study, you will need to download, look over and sign, and return to us (by email or mail) the medical record release forms on this website, below. We can also email them to you. This form explains how we collect, store and use private health information in detail.

If you do not sign and return the form, you cannot be in the research study. We will also send you one or two forms to look over and sign, giving us permission to get health records from other hospitals and doctors’ offices.

If you agree to let us use your protected health information, we will collect health information about you until the end of the research. We may collect some information from your medical records even after your direct participation in the research project ends. We will keep all the information until the end of the study, in case we need to look at it again. We will protect the information and keep it confidential.

If you agree, we will also be sharing information related to your heart event and medical history with the International takotsubo Registry, the largest study of takotsubo patients worldwide. We hope this will contribute further to our understanding of this disease. In addition to de-identified clinical information, we will only share your date of hospitalization, date of diagnosis, and date of discharge at the time of your heart event. This is required to understand key timing around this event. These dates have the potential to identify you. We will not share your name, address, social security number (if you provided it), email address, telephone number, or the names of your doctors. The InterTAK registry will not contact you directly.

If you have any questions, please email BrokenHeartStudy@NYULangone.org. You can also call Dr. Harmony Reynolds at 212-263-7751 with questions about the research use of your health information for the research study.