Anyone asked to take part as a subject in a medical research study or asked to agree on behalf of someone else, has the right to understand the following:

1. What the study is about and why it is being done.
2. What you will have to do if you take part in the research study and what treatments, drugs or medical devices, if any, will be used.
3. Any pain or discomfort you may expect to feel and what risks you might run, if any, from taking part in the research study.
4. What benefit to your health, if any, you might get from taking part in the research study.
5. Other non-research treatments, drugs or medical devices that may be available to treat your illness and a comparison of the risks and benefits of these other treatments with the one you are being asked to agree to receive.
6. What medical treatment, if any, will be available to you after the research study, if medical complications arise as a result of the study.
7. You will be given a chance to ask questions about the research study, until you are satisfied that you understand what is involved. You should expect your questions to be answered clearly, fully and honestly.
8. If you agree to take part in the research study, you can later change your mind at any time without being penalized. Leaving the study will not affect your usual medical care.
9. You will not be pressured, forced, misled, given wrong facts, bribed or unfairly influenced to get you to agree to take part in the experiment.
10. You will be given a copy of any consent form you sign for the research study.

The following is a short summary of this study to help you decide whether to be a part of this study. More detailed information is listed later in this form.

We invite you to take part in a research study because you are an adult 40 years of age or older and you do not have any symptoms of heart disease.

• Someone will explain this research study to you.
• Whether or not you take part is up to you.
• You can choose not to take part.
• You can agree to take part and later change your mind.
• Your decision will not be held against you.
• You can ask all the questions you want before you decide.

The purpose of this research is to build a registry (a research database) to learn how common an elevated coronary artery calcium (CAC) score is among adults who do not have symptoms of heart disease. CAC is calcium that builds up in the walls of the arteries that supply blood to the heart. It is an early sign of atherosclerosis (a build-up of plaque in the arteries), and people with higher CAC scores have a higher chance of having a heart attack or other heart problems in the future. A CAC scan is a quick, non-invasive CT scan that measures the amount of calcium in these arteries.

The registry will also look at how CAC scores differ by age, sex, and heart disease risk factors such as smoking, high blood pressure, diabetes, and a family history of heart disease. What we learn may help doctors better identify people who are at risk of heart disease before they have symptoms.

We expect that you will be in this research study for one study visit, which will take about 30 mins to an hour. Your participation will end at the end of this visit. There is no follow-up.

You will be asked to answer questions about yourself and your health, such as your age, sex, smoking history, blood pressure, diabetes, and family history of heart disease. You will then have one CAC scan, which is a type of CT scan of your heart. The scan itself takes less than 10 minutes. No dye (contrast) will be injected and no blood will be drawn.

More detailed information about the study procedures can be found under “What happens if I say yes, I want to be in this research?”

The main risk is exposure to a small amount of radiation from the CAC scan. The scan may also find something unexpected (an “incidental finding”) that needs more testing, which may cause you worry. There is also a small risk that your information could be seen by someone who is not supposed to see it.

More detailed information about the risks of this study can be found under “Is there any way being in this study could be bad for me? (Detailed Risks)”

We cannot promise any benefits to you or others from your taking part in this research. However, possible benefits include learning your CAC score, which you may find useful to discuss with your own doctor when talking about your risk of heart disease. The study does not provide medical advice or treatment. Your taking part may also help other people in the future by helping researchers learn how common coronary artery calcium is in adults without symptoms of heart disease.

Participation in research is completely voluntary. You can decide to take part, not take part, or stop taking part at any time without penalty or loss of benefits to which you are otherwise entitled.

Your alternative to taking part in this research study is to not take part.

Detailed Information: The following is more detailed information about this study in addition to the information listed above.

WHOM TO CONTACT ABOUT THIS STUDY

During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns or complaints about the study such as:

• Whom to contact in the case of a research-related injury or illness;
• Payment or compensation for being in the study, if any;
• Your responsibilities as a research subject;
• Eligibility to participate in the study;
• The study doctor’s or study site’s decision to withdraw you from participation;
• Results of tests and/or procedures;

Please contact the study doctor at the telephone number listed on the first page of this consent document.

If you seek emergency care, or hospitalization is required, alert the treating physician that you are participating in this research study.

An institutional review board (IRB) is an independent committee established to help protect the rights of research subjects. If you have any questions about your rights as a research subject, contact:

Please reference the following number when contacting the Study Subject Adviser: PRO04273039.

We expect up to 10,000 people in total to be in this research study across all participating sites. This site is one of the participating sites for the registry. Because sites enroll on a competitive basis, the number of people taking part at each site may vary.

If you agree to take part, everything will be done at one study visit at this site. The steps are:

1. Consent and eligibility. A member of the study team will review this form with you and answer your questions. No study procedures will be done until you sign this form. The study team will confirm that you can be in the study. You cannot take part if you:

• Have a known history of coronary artery disease, heart attack, or stroke, or have had a procedure to open or bypass blocked arteries in your heart or legs (such as a stent or bypass surgery)
• Are pregnant or think you may be pregnant. We will be doing a urine pregnancy test, if you are a female of childbearing age after you sign this consent form to confirm you are not pregnant.
• Have had a CAC scan in the last 6 months
• Weigh more than 400 pounds or more than the weight limit of the CT scanner table
• Have any other condition that the study doctor believes would make it unsafe for you to have the scan

2. Questions about you. The study team will ask you about your age, sex, and heart disease risk factors, such as whether you smoke, have high blood pressure or diabetes, and whether anyone in your family has had heart disease.

3. CAC scan. During CT scan, you will lie on your back on the CT scanner table on a padded table. Small sticky pads (ECG leads) will be placed on your chest to track your heartbeat. The table will slide into a large, donut-shaped machine. A quick first picture will be taken to line up the scan, and then you will be asked to hold your breath for a few seconds while the pictures of your heart are taken. The scan takes less than 10 minutes. No dye (contrast) is used, and there are no needles or blood draws. The CAC scan is being done only for research.

4. Your results. Your CAC score (called an Agatston score) and its category (0, 1–99, 100–399, or 400 and above) will be recorded in the study database and shared with you. With your permission, your result can also be shared with your doctor. If the scan shows something unexpected that the study doctor believes needs medical follow-up, the study team will tell you and your doctor.

5. End of the study. Your participation ends when the study visit is over. There are no follow-up visits or phone calls for this study.

The information collected about you (your answers to the study questions and your CAC scan result) will be entered into the registry database using a study ID number instead of your name. It will be combined with information from other people to learn how common elevated CAC scores are and how they relate to age, sex, and heart disease risk factors. No blood, urine, or tissue samples will be collected.

This study is not part of your health care. The CAC scan is done only for research purposes.

You can leave this research at any time; it will not be held against you. Taking part in research is voluntary.

If you decide not to take part in the study, or if you choose to leave the study, your choice will not affect any treatment relationship you have with healthcare providers at the site or services you receive from them or at any other healthcare facility. No matter what you decide, and even if your decision changes, there will be no penalty to you. You will not lose medical care or any legal rights.

Please let the research team know if you choose to leave the study. Because this study has only one visit, you can stop at any time during the visit, including before or during the scan. You may also later ask that your information be removed from the registry. We will do our best to honor your request. However, because your information may already have had your identifiers removed and been included in combined (group) results, it may not always be possible to remove it completely.

If you are an employee or relative of an employee of this research center, you are under no obligation to participate in this study. You may withdraw from the study at any time and for any reason, and neither your decision to participate in the study, nor any decision to withdraw, will have any effect on your performance appraisal or employment at this clinical research center. You may refuse to participate or you may withdraw from the study at any time without penalty or anyone blaming you.

There are risks to participating in this research. The study doctor and study team will monitor you to see if you are experiencing any harm related to your participation. If you experience any pain or discomfort, you must inform the study team as soon as possible.

Radiation: This research study involves exposure to radiation from one CAC scan. The estimated radiation dose you will receive from the scan is about 1 to 1.5 mSv. A millisievert (mSv) is a unit of measurement for radiation. No amount of radiation is considered completely safe. For the sake of comparison, the average person in the United States receives about 3 mSv each year from natural background radiation, and a standard chest CT scan gives about 7 mSv. The study uses a low-dose scan without contrast (dye), and methods to reduce radiation dose will be used to keep your exposure as low as reasonably possible.

Unexpected findings: The CAC scan may show something unexpected (an incidental finding) that needs further testing. Learning about a possible health problem may cause you worry or anxiety while it is being checked. Any follow-up tests or care would be through your own doctor and are not part of this study.

Privacy: There is a small risk that your information could be seen by someone who is not supposed to see it. The steps we take to protect your information are described below under “What happens to the information collected for the research?”

Pregnancy: Radiation from the CAC scan may harm an unborn baby. If you are pregnant or think you may be pregnant, you cannot take part in this study. Please tell the study team if there is any chance you could be pregnant. Our study team will be doing a rapid urine pregnancy test on female participants who are of childbearing age.

We will do our best to protect your data during storage and when they are shared. However, there remains a possibility that someone could identify you. There is also the possibility that people who are not supposed to might access your data. In either case, we cannot reduce the risk to zero.

There may be other risks that are unknown.

There is no cost to you for the CAC scan or any other procedures done for this study.

If the scan shows an unexpected finding and you choose to have follow-up tests or care with your own doctor, those costs would be your or your health care insurance’s responsibility.

You will not be paid for your participation in the study. You may be reimbursed for costs related to your participation, such as travel, transportation, or parking, up to the discretion of the study staff or the investigator along with submission of the original receipts. You will not be paid for unscheduled visits. You will be paid following each completed visit, if applicable.

We will do our best to limit the use and disclosure of your personal information, including information from this research study and from your medical records to people who have a need to review this information. We cannot promise complete confidentiality. Organizations that may inspect and copy your information include:

• The Institutional Review Board (IRB)
• Other representatives of this organization (such as offices and committees responsible for the oversight of research) and other collaborating researchers outside of this organization.
• Personnel who schedule or perform the CAC scan or do other tasks related to this study.
• Study staff at the Coordinating Center which collects and manages data from all sites.
• Collaborating researchers outside of the site who may receive de-identified data from the registry for future research.
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (“The Lundquist Institute”)

We have strict rules to protect your personal information and protected health information (PHI). We will limit who has access to your name, address, phone number, and other information that can identify you. You will be given a study ID number, and your name will not be entered into the registry database. The link between your identity and your study ID will be kept at your study site, separately from the registry database, and only designated study staff will have access to it. Study data will be kept in a secure, access-controlled electronic database, and only members of the research team who need access to properly conduct the study will be able to see it. Your information will not be released in a way that identifies you, except as required by law or as you allow.

Federal law provides additional protections of your medical records and related health information. These are described in an attached document.

Your study information will be stored in the CAC-Registry database, which is managed by the Coordinating Center at The Lundquist Institute in Torrance, California. Access is limited to their study team and people they designate. The registry database will be kept for as long as the registry remains active or until the study doctor closes the registry.

If identifiers are removed from your identifiable private information that is collected during this research, that information could be used for future research studies or distributed to another investigator for future research studies without your additional informed consent. See the information found under “Will my data be used for future research?”

This study is collecting data from you. We would like to make your data available for other research studies that may be done in the future. The research may be about heart disease or similar conditions. However, research could also be about unrelated diseases, conditions, or other types of research. These studies may be done by researchers at this institution or other institutions. Our goal is to make more research possible. We plan to keep your data for up to 15 years after the completion of this study. To get your data, future outside researchers must seek approval from this institution and review by an IRB may be required.

Your name and identifying information will be removed from your data before the data are shared with other researchers. Researchers cannot link your identifying information to the data.

Participating in this study means you agree to share your data. You can change your mind later, but researchers might still use your data if they have already been shared. If you do not want your data used for other research studies, you should not participate in this study.

This study is not designed to help you directly. You will learn about your CAC score, which you may find useful to discuss with your own doctor. However, the study does not provide medical advice or treatment. If you ask, and with your permission, we can share your result with your doctor. Your taking part in the study may benefit other people in the future by helping us learn more about how common coronary artery calcium is in adults who do not have symptoms of heart disease.

This study is not a substitute for your regular medical care. You should continue to see your regular medical providers.

The person in charge of the research study can remove you from the research study without your approval. Possible reasons for removal include the study doctor deciding that taking part is not in your best interest, for example if it would not be safe for you to have the scan.

Any new important information that is discovered during the study and which may influence your willingness to continue participation in the study will be provided to you in a timely manner.

If you are injured as a direct result of the study drug(s) and/or device or procedures required by this study, you will be provided with appropriate medical care including treatment and hospitalization if necessary. This medical care will not necessarily be free of charge. The sponsor of this study agrees to pay for such medical care including treatments and hospitalizations. If the sponsor pays any of your medical expenses, we may be required to give the sponsor your name, date of birth and Medicare ID or social security number. Financial compensation for such things as lost wages, disability or discomfort due to an injury is not routinely available.

If you are injured because of this research, you should first try to contact your study doctor, who is listed on the first page of this consent document. If you cannot reach your study doctor, you may call the hospital emergency department (adult, 424-306-5001, or pediatrics, 424-306-5054). You can also call the Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (“The Lundquist Institute”) Compliance Office, 310-222-3624, for further information on the availability of medical treatment or compensation.

Your CAC scan result (your CAC score and category) will be shared with you. With your permission, it will also be shared with your doctor. If the scan shows something unexpected that the study doctor believes needs medical follow-up, the study team will tell you and your doctor. Results from the whole registry (for example, in publications or presentations) will not identify you.

You may be emailed a PDF copy of this signed and dated consent form. There may be risks of loss of privacy and confidentiality if the PDF copy of this consent form is viewed and/or stored on a personal electronic device (PED), especially if that PED is shared with other users or is lost, hacked, or subject to a search warrant or subpoena. Also, the PDF copy of the consent may not be able to be permanently removed from a PED.

We would like your permission for our research team to contact you in the future about whether you may be eligible for a separate, related research study, based on your CAC score. If you say “yes,” you will be asked to provide your contact information, which will be stored securely at your study site. Any future study would have its own approval and its own Informed Consent Form. If you say “no,” you can still take part in this registry study. Please note that your decision below does not prevent other researchers at the site from contacting you about other research.

Please sign and date your choice below:

Yes, I agree to be contacted for future research studies

Re-signClear

Signature of ParticipantAmit Johanis

11/12/2026

Date

I have read this consent form (or it has been read to me). All my questions about the study and my part in it have been answered. I freely consent to be in this research study.

By signing this consent form, I have not given up any of my legal rights.

CONSENT SIGNATURE:

Re-signClear

Signature of Subject (18 years and older)Amit Johanis

11/12/2026

Date

If this consent form is read to the subject because the subject is unable to read the form, an impartial witness, not affiliated with the research or investigator, must be present for the entire consent process and sign the statement below.

My signature below documents that the information in the consent document and any other written information was accurately explained to, and apparently understood by, the subject, and that consent was freely given by the subject.

I certify that I have reviewed the contents of this form with the person signing above, who, in my opinion, understood the explanation. I have explained the known side effects and benefits of the research.

Re-signClear

Signature of Person Conducting Informed Consent DiscussionLocal (login disabled)

11/12/2026

Date

I certify that I am the principal investigator and am responsible for this study, for ensuring that the subject is fully informed in accordance with applicable regulations.

The purpose of this authorization is to explain to you how the researchers propose to use your protected health information for the purposes of the research you are being asked to participate in. None of your protected health information (data) will be used for the research without your written permission.

Your protected health information will be used for the purpose(s) described in the informed consent form for the research study you are being asked to participate in and for any future research.

If you sign this authorization, the site researchers and the research team may use your protected health information (PHI). They will use your study research record and information from your medical record.

If you decide to be in this study, the study doctor and study staff will use and share health data about you to conduct the study. Health data may include:

• Your name.
• Address.
• Phone number.
• Date of birth.
• Medical history.
• Information collected/obtained from your study visits, including all test (CAC) results, assessments and responses.

For this study, the study staff may share health data about you with authorized users. Authorized users may include:

• The site Investigator and the research team/staff or other collaborating researchers outside of this organization.
• Governmental Regulatory Agencies such as the U.S. Department of Health & Human Services Office of Human Research Protection (OHRP) and/or U.S. Food and Drug Administration.
• Exponent and its authorized representatives.
• Representatives of Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (The Lundquist Institute).
• Institutional Review Board (IRB).

Once your health data has been shared with authorized users, it may no longer be protected by federal privacy law and could possibly be used or disclosed in ways other than those listed here.

This permission will be good until December 31, 2046. However, if you reside in California, the collection of your health data will stop when the study has ended and all required study monitoring has been completed.

You may revoke (take back) your permission to use and share health data about you at any time by writing to the study doctor at the address listed on the first page of this form. If you do this, you will not be able to stay in this study. No new health data that identifies you will be gathered after your written request is received. However, health data about you that has already been gathered may still be used and given to others as described in this form.

Your right to access your health data in the study records will be suspended during the study to keep from changing the study results. When the study is over, you can access your study health data.

If you decide not to sign and date this form, you will not be able to take part in the study.

I have read this form and its contents were explained. My questions have been answered. I voluntarily agree to allow study staff to collect, use and share my health data as specified in this form. I will receive a signed and dated copy of this form for my records. I am not giving up any of my legal rights by signing and dating this form.

AUTHORIZATION SIGNATURE:

Re-signClear

Signature of Subject (18 years and older)Amit Johanis

11/12/2026

Date

If this consent form is read to the subject because the subject is unable to read the form, an impartial witness, not affiliated with the research or investigator, must be present for the entire consent process and sign the statement below.

My signature below documents that the information in the consent document and any other written information was accurately explained to, and apparently understood by, the subject, and that consent was freely given by the subject.