Frequently Asked Questions

• Respond to surveys: You’ll be asked to agree to the study terms, complete the pre-screening survey, and consent to share your survey responses with the UNRAVEL team. At that point, some participants will be invited to complete a detailed online health survey on past and present health symptoms, as well as other aspects of their health.
• Connect your EHRs to Hugo Health: Study participants will also be asked to connect their EHRs to our study database using Hugo Health’s Hugo Connect tool. This allows medical records to be securely shared directly from your health system to the UNRAVEL Study team. You must also provide consent for this EHR data sharing.
• Provide blood samples and body measurements: Some participants who fulfill all the eligibility criteria will be invited to provide biospecimen samples. You’ll be directed to a nearby Quest Diagnostics center to schedule a blood draw at no cost. Your height, weight, blood pressure, hip circumference, and waist circumference will also be measured at the appointment.
• Optionally provide saliva samples: Some participants who fulfill all eligibility criteria will be invited to share genomic data for ancestry analysis. This will be collected from saliva samples using collection kits sent to your home at no cost by Galatea Bio and its Biobank of America.

Eligible participants must be age 18 years or older, live in the United States, and have a medically confirmed diagnosis of ASCVD, with documentation in EHRs at the time of any study procedure or event. In our study, a diagnosis of ASCVD will include:

• Myocardial infarction (MI), or a blockage of blood to the heart, otherwise known as a heart attack
• Ischemic stroke, or a blockage of blood to the brain
• Clinically significant symptomatic peripheral artery disease (PAD), or a narrowing of the vessels that deliver blood from the heart to the rest of the body

Those who are willing to participate in the consent process, online pre-screening questionnaire, and EHR data connection through Hugo Connect will be eligible to be selected for the study. Participants must have an active email account and phone number for ongoing communication with the UNRAVEL Study coordinators. All participants must live within a reasonable distance of a Quest Diagnostics center.

The study seeks participants who identify as belonging to any of these racial or ethnic groups: Hispanic, non-Hispanic Black, non-Hispanic South Asian, or non-Hispanic White. Non-Hispanic South Asians will be defined as individuals with ancestry from Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, or Sri Lanka.

The only costs to participate in this study may include transportation and your time traveling to and from a Quest Diagnostics blood draw appointment.

There is no payment provided for participating in this study. Participants will receive all laboratory, biometric, and genomic screening at no cost.

Yes. Participants will receive their Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory results from Quest Diagnostics following their blood draws. Participants will also receive personalized genomic results from Galatea Bio following the processing of their saliva samples.

As a research study, we can’t provide any medical advice. We recommend that participants consult their primary care physicians or cardiologists for referrals or medical advice, particularly for heart health. Survey responses and personal data received will not be reviewed by the UNRAVEL Study research team immediately. Since participants are not being monitored or evaluated in real-time, should any adverse or severe symptoms occur, they should be reported directly to prescribing physicians, primary care physicians, or emergency room physicians as they would be in the normal course of health care.

The physical risks associated with this study are very small. The blood draws present minimal risks which include pain, a bruise at the point where the blood is taken, redness and swelling of the vein and possible infection, and a rare risk of fainting.

However, all research studies involve some risk to participant privacy: When you share your personal health information with researchers, there is a risk that someone might access that information improperly. However, the research team has strict protocols in place to prevent inappropriate access to your data, including keeping audit logs of everyone who has accessed your data at Yale.

In addition, any information extracted from your medical record will be kept on Yale’s secure servers. All email communications between participants and our study team will be secure, sent from a Yale email address, and encrypted.

Information collected from participants for this study may be used for future research or shared with other researchers. If this happens, we will remove any information that could identify participants before it is shared. Since identifying information will be removed, we will not ask participants for additional consent. The goal is to have as many scientists working on these data as possible to accelerate progress in heart health. However, the shared data will always be de-identified to protect participants’ identities.

Participants have the right to leave the study at any time without penalty. We will not gather any new information after they leave the study. However, the information already collected will be retained and used as noted above.

Withdrawing from the study will involve no loss of benefits that participants are otherwise entitled to or harm their relationships with their healthcare team.

The researchers have the right, without consent, to stop any participant from continuing in this study if:

• researchers believe it is in the participant’s best interest
• the participant does not follow study instructions
• researchers cancel the study for any reason

This study is focusing on understanding Lp(a) levels in different groups, and looking at connections between Lp(a) levels and familial factors which includes genomic/ancestry data. Your genomic data for ancestry analysis will be collected from saliva samples using collection kits sent to your home by Galatea Bio. When you send back the kit to Galatea Bio, they'll process your saliva, run the analysis, and calculate risk scores for several cardiovascular conditions.

Yes. Providing your genomic data is optional.

The study is unable to use ancestry analysis results from companies like Ancestry.com and 23 & Me. To provide your saliva sample, you must use the Galatea Bio specimen collection kit.

Your biospecimen, genetic data, and/or clinical information may be used anonymously (without information directly identifying you) for research, education, and other business purposes of Galatea Bio and its academic and commercial collaborators, including research and medical product development. You will not share in any commercial profits if research leads to medical or other products. This may involve Galatea Bio sharing aggregated information, summary statistics, or non-identifiable biospecimen and/or clinical information with other third parties including academic and commercial collaborators, which may be outside the country.

The UNRAVEL study works exclusively with Quest Diagnostics Laboratories. Please use this link to find the lab closest to your location.

We don't have the ability to do in-home blood draws and/or in-home gathering of your biometric data. Please use (this link) to find the lab closest to your location.

At your Quest Diagnostics Laboratory appointment, measurements including blood pressure, weight, waist circumference, and height will be taken.

Depending on how quickly you complete your survey, your blood draw/biometric measurements, and saliva sample, your involvement could take as little as 3-6 hours over a one month period.

Yes! We're always looking for eligible participants. We do ask that you refer people to whom you are not blood related. Please direct them to the UNRAVEL website and have them click on the "Join UNRAVEL" button to take the pre-screening survey.

Connecting your health data allows for the UNRAVEL Study team to receive real-time updates on your health, which is impossible to do if records must be requested, faxed, emailed, or mailed.

Additionally, sending emails and faxing records are not secure methods of transmission. Data that participants send using Hugo Connect are encrypted so that even if they are intercepted, it would be nearly impossible to decipher.

Hugo Health, the company that manages the Hugo Connect tool that participants will use to connect medical records, takes security very seriously. They follow the federal law called the Privacy Rule of the Health and Insurance Portability and Accountability Act (HIPAA) and other entities including the Federal Trade Commission (FTC). Hugo Health is an approved member of the Creating Access to Real-Time Information Now Through Consumer-Directed Exchange (CARIN) Alliance, which has set the standard for patient privacy and security of health data.

Strict protocols control any data shared, including keeping audit logs of everyone who has accessed your data at Yale. The data you contribute to the UNRAVEL study will not be shared with healthcare providers, other research studies, or anything else without your explicit permission.

Information that is used for the study will be kept on secure Yale servers. Additionally, all email communication to participants will be sent from a Yale address and specially coded to prevent unauthorized access.

In the spirit of open science, the UNRAVEL Study team, Quest Diagnostics, and Galatea Bio may share de-identified data with others to support further health research, but this data would not have participants’ names or any other information that could be used to identify them.

Data is most vulnerable when it is moving between two different locations. To combat risk, Hugo Health encrypts data while it is in motion. In the rare instance that it is intercepted, there is virtually no possibility of turning it into information that makes sense, has any meaning, or can be tied back to the person. They also encrypt data at rest, meaning even when it is not in motion.

The data shared with researchers is uploaded to an SFTP server, which stands for Secure File Transfer Protocol. This standard is used for many industry-related data types, including but not limited to health data.

While Hugo Health is not required to adhere to HIPAA standards, they follow the regulations required by HIPAA-covered entities.

1. On the UNRAVEL connections page, please click on the Connect with Hugo button.
2. A pop-up welcome window will appear. Click “Continue.”

3. In the next window, enter your email address.

4. An email will be sent to the email address you entered, with the subject line beginning [Hugo Connect]. Please check your spam/promotions folder as these emails sometimes route there. Once you receive the code, enter it into the boxes at the bottom of the window.

5. There will be a link in the email for you to sign into Hugo Connect. Please note that the link expires after 10 minutes and can only be used once.

6. Once you have closed that tab, you can then begin to search for healthcare systems, devices, or insurance providers to connect to.

7. Enter the name of the healthcare system, hospital, clinic, etc. in the search box and hit enter.

8. If you do not see what you are looking for, please review these search considerations for helpful tips.

9. The opportunity to enter your username and password connection should present itself immediately, either in the connection widget window or in a new tab.

1. If a new tab does not open, and there is no place to enter your username and password, please disable your pop-up blocker.
2. If a new tab opens, you will be walked through the authorization process via your provider’s patient portal.

10. After you finish the process, you should see a screen indicating there’s a successful connection.

11. If you do not see a status indicating a successful connection, please see these troubleshooting steps to resolve the issue.

12. At any time, you can view your connections by clicking the link "Want to modify existing connections? Make Changes" at the bottom of the window.

13. If you have any other questions, please feel free to email us at unravelstudy@yale.edu and we will be happy to help.

No, removing a connection will stop all data from updating in your account. However, if the goal is to delete all prior data, then participants must contact Hugo Health’s support team directly at support@hugo.health and request that be deleted from their accounts. It is possible to delete data and keep a personal account active or instead request that a personal account be deleted.

1. On the Hugo Connect window, click the link "Want to modify existing connections? Make Changes" at the bottom of the window.

2. On the next window, click the “X” next to the connection you want to remove/unlink.

3. On the next window, click “Unlink This Connection.”

4. A second window will appear where you will confirm that you want to unlink the connection.

5. You will be returned to your connections list, where only your active connections will appear.

While the study recommends connecting your records, occasionally uploading files is necessary when a connection cannot be made.

1. Save the downloadable (.pdf, .doc, etc.) files from your provider’s portal to your computer, or ask your provider to send you electronic copies.
2. On the Hugo Connect window, at the bottom of the list of example connections select "Upload a New File."
   

3. Click the "Upload" button and select the files you would like to share.

4. Click “Browse” to be taken to the files on your computer.

5. From the list of files on your computer, select the one(s) you would like to upload.

Please note, uploading one at a time allows you to enter descriptive information about each one. Uploading multiple files is fine but requires that you describe them as if they are a single entity.

6. Provide a description for your file(s) and save.

7. You can view your uploads by clicking the link "Want to modify existing connections? Make Changes" at the bottom of the window.

If a specific provider is not listed as a connection:

• Check their patient portal. Does it have a similar or different name listed? For example, "My UofM Health" is the health system for the University of Michigan.
• Check the clinic location. Is it part of a larger health system? The larger system may have a connection for sending records through the portal.
• Consider whether the provider may be listed by an acronym or a longer legal name.
• Hugo Connect does not typically include individual providers and private practices. Hugo Connect more often includes larger clinics, hospitals, and health systems.

If a connection error states, “Needs Attention,” it can easily be fixed with the following steps:

1. Use a supported browser (Firefox, Chrome, or Safari). Using a different browser or mobile device/tablet can cause functionality issues.
2. Go to Connections in the Hugo console.
3. Next to the name of the selected connection, click on the wrench icon.
4. From the small pop-up window, select “Manage” or “Repair Connection.”
5. On the next pop-up window, click the blue “Update” button.
6. If the website does not prompt login credentials (a place to enter a username and password) immediately, or open a new tab, then please disable pop-up blockers.
7. If given the option, grant access to all data for a minimum of one year. It is possible to revoke access at any time.
8. At the end of the process, a window should open that states, "You're all Set". Without that window appearing, the connection was likely not successful.