NOMBRE DEL PROCESO: ADMINISTRACIÓN DEL RECURSO HUMANO

Echo Laboratory (~1 hour)

• For the fourth and final visit, you will meet Jacqueline Augustine, researcher, in the lobby of Upstate University Hospital. You will be escorted to the Echocardiography laboratory to have a non-invasive, 3-dimensional echocardiography of your heart. This procedure will be performed by a certified echocardiography technician/researcher and accompanied by Dr. Liu.

• The imaging of your heart will be non-invasive (no needles, no blood) using a Doppler ultrasound technique, which is very similar to the probe used to measure your neck and leg blood flow during Visit 3 at Syracuse University. An ultrasound probe will be placed on your chest near the left side of your chest. The technician will take 1-2 images of your heart.

• We will also measure ankle-brachial index (ABI), which measures your artery function. This is a non-invasive test that will compare the blood pressure at your ankles with the blood pressure at your arm. This procedure indicates of how good your circulation is throughout your body.

• This visit to the echocardiography lab will take approximately 30 minutes, however, the total duration of the visit to Upstate University Hospital will take ~1 hour with parking, arrival and imaging.

A University Hospital (UH) medical record will not be created for you as a participant in this study. If you already have a medical record at UH, we will not add the tests being done for this study to your UH medical record. A copy of your test results will be kept in Dr. Liu's study records; therefore, if you want a copy of the test results, please contact Dr. Liu at

[email protected] or (315) 464-9335.

RISKS & DISCOMFORTS:

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• We will use a small amount of gel to help us measure your brain blood flow. There is minimal risk of gel getting into your eye when we measure brain blood flow due to the small amount of gel used in this technique. Nonetheless, we will remind you to remain still as we take these measures to ensure that the gel does not come into contact with your eye. The gel is water- based and is designed for eye exams so in the event some comes in contact with your eye the discomfort should be minimal and temporary and can be rinsed out easily. We will escort you quickly to a sink to rinse out your eye if discomfort occurs.

• You may experience discomfort from the finger stick to test your blood lipids, cardiac

function, inflammation, hematocrit and hemoglobin. This will only be done two or three times and no more than that. We will use different fingers each time to reduce discomfort. If desired we can also place ice on the finger prior to the finger stick to reduce discomfort from the pinch. • There is a small risk of infection associated with the finger stick. However, we will reduce this

risk by ensuring that equipment is clean and sterile and the finger stick technician will wear lab coat, gloves, will clean the finger with alcohol swabs and will clean the area with a disinfectant wipe afterwards.

• You will be asked to come to Visit 1 (≥12 hours fast) and 3 (≥12hours fasted) following a fast. It is possible that you may experience some gastrointestinal discomfort by the end of testing from feelings of hunger or experience symptoms of low blood sugar such as, feeling faint or dizzy. Although this is not anticipated, as many people do not consume food for large breaks during the day, we will provide a light snack at the completion of testing (granola bar) if you are hungry. It is important that we have participants arrive fasted because food consumption can greatly affect vascular function based on the timing and content of the meal.

• There are risks associated with exercise.

• There is a small risk of losing consciousness following intense exercise. We will

minimize this risk by having you “cool-down” following the cardiorespiratory fitness test at visit 2. This will prevent the blood from staying down in your legs and will reduce the risk of light-headedness or dizziness after exercise. Additionally, we will ask you

communicate directly with us if you feel any light-headedness so that we can take appropriate precautions.

• Any type of exercise may, in rare instances, lead to heart attack, stroke or death;

however, this is unusual, especially in adults free of known cardiovascular disease, free of any signs or symptoms of cardiovascular disease, and with few major risk factors of cardiovascular disease. Thus, risks associated with exercise are low in healthy, middle- aged adults. Our multi-stage screening process will help us ensure that exercise is appropriate and safe for you. The multi-stage screening process will let us identify any pre-existing conditions or abnormalities that might limit exercise. By design, our

exclusion criteria and extensive health screening prior to the exercise visits (visit 2 and 3) will remove you from participating if you are a high-risk individual.

• Based on our criteria however, you may be a moderate-risk individuals (i.e. you have >2 cardiovascular risk factors). The odds are, if you have high blood pressure you will fall into this moderate-risk group. As mentioned previously, we will require you to obtain clearance from your physician to participate in the exercise portion of the study if you are in this moderate-risk group (>2 cardiovascular risk factors). If you are unable to obtain

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clearance from your physician you will not be allowed to participate in the exercise visits. • It should be noted that exercise is widely recommeneded by health organizations as a

lifestyle modification to reduce the negative effects of cardiovascular disease, even in moderate-risk populations with high blood pressure. Our multi-stage screening process and physican clearance steps will ensure that you will only engage in exercise if it is appropriate and safe for you, thus these risks should be minimal should you be cleared for the exercise portions of the study.

• Communicating with the researcher throughout the protocol will reduce risks.

• It is possible that we may find out something about your health that you did not know about. In the event we discover any significant medical abnormalities during the course of your participation in this study, we will inform you and your primary care physician, if you wish. If you do not have a primary physician, an appropriate referral will be made. • If at any point, you are uncomfortable or feel pain anywhere, please tell us immediately. BENEFITS:

• There is no direct benefit to you for participating in this research study; however, the information learned may help others in the future.

• You will receive information on your blood pressure, cholesterol level, body

composition, aerobic fitness, cognitive function, heart structure and function. However, These tests are not being used to diagnose a problem (NOT for medical/clinical purposes). These tests are being performed for research purposes only. If you have high blood pressure, high cholesterol, high blood glucose, depression, or blood in your urine we will inform you to go the university health center or your health care provider. If an abnormality is detected on the 3D echocardiography, low ABI is detected or an abnormal heart rhythm is observed, you will be referred to the cardiologist, lead physician on this study, Dr. Kan Liu.