The purpose of this research study is to learn more about a heart condition called Spontaneous Coronary Artery Dissection (SCAD).
We would like to learn whether patients who have had SCAD syndrome have been hospitalized for heart problems again and would like to learn about quality of life in patients who have had SCAD.
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 record information about the time you had your heart event, 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 personal information that we receive from you, for example, your name and any other identifying information, will be strictly confidential and will be kept under lock and key.
We will contact you approximately in one month, six months, 12 months, and then every year for up to 10 years, electronically or by telephone, to ask you about any hospitalizations or new medical problems. We will collect your medical records as needed to confirm whether you had SCAD or another heart event, or what else may have happened to you. We will also ask you about the medications you take. We will ask you the quality of life questions at each visit. We will get images and medical records 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.
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. The Research Authorization form can be downloaded by clicking the link below. 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 also ask you to complete the Medical Records Release form, which can be downloaded by clicking the link below. This gives us permission to get health records from other hospitals and doctors' offices, if necessary and relevant to this study.
If you agree to let us use your protected health information, we will collect health information about you until the end of the study. We may collect some information from your medical records and publicly available records even after your direct participation in the research project ends. 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 Canadian SCAD study, the largest study of SCAD 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 birth, 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 and to make sure the same participant is not enrolled more than once. 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 Canadian SCAD study team will not contact you directly unless you provide separate consent for that.
If you have any questions, please email NYUSCAD@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.
If you agree to take part in this research, please complete the following steps:
- Please click the button below that says, "I have read the above consent, and I agree to participate in the NYU SCAD Study."
- Please then add your electronic signature by clicking "Add Signature" and using your mouse to electronically sign your full name.
- Please fill out the date and time of consent by clicking the button that says, "Now."
Once you complete the above steps, please do the following:
- Download the Medical Records Release and Research Authorization forms.
- Fill them out
- Upload them under the appropriate links titled, "Upload Document." It is OK to upload just the last page of the Research Authorization form, if that is easier for you. If you are having trouble with the uploads, you make take pictures of the signed forms and send the pictures by email to NYUSCAD@nyulangone.org or fax the documents to Dr. Harmony Reynolds at 929-455-9234.
The next part of this Initial Intake Survey will ask you to answer questions about your SCAD history.
For any questions, please contact us at NYUSCAD@nyulangone.org or #347-515-1154.
Thank you for your time.
With best wishes for your health,
The NYU SCAD Study Team
Principal Investigator: Harmony Reynolds, MD
530 First Avenue, Suite 9U
New York, NY 10016
Telephone: 212-263-7751
Fax: 929-455-9234
NYUSCAD@nyulangone.org
NYU IRB #s20-00273
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