Exosome Cargo From Preeclampsia Patients

Study Update: In evaluating the contents of the exosome cargo, we have discovered two important biomarkers - vasorin and angiotensin - are inversely correlated in preeclamptic vs. healthy patients. The angiotensin to vasorin (ANG/VASN) ratio is low in healthy patients vs. elevated in preeclamptic patients. We would like to extend this study to collect more samples in an effort to further explore this biomarker relationship in exosome cargo. The device is the VENDYS-II device (Endothelix, Palo Alto, CA). It is a device approved by the FDA to measure vascular reactivity using non-invasive means. The way it detects vascular reactivity is by measuring the peripheral temperature changes in the finger pads of the index fingers before, during, and after arterial occlusion by a blood pressure cuff. A temperature sensor is placed on the finger pad of both the right and left index fingers. A baseline temperature is measured by the device for 5 minutes. Then, a blood pressure cuff will occlude arterial flow to the right arm for 5 minutes. Temperature differences in both index fingers will continue to be measured during this time. After 5 minutes, the cuff deflates, and the device will measure temperature changes in both fingers for a final 5 minutes (15 minutes total). Temperature differences during the ischemia-reperfusion time will be used to calculate the patient's vascular reactivity. The device for its intended purpose as outlined by the FDA. It is non-invasive. The purpose of adding this device is to determine if there is a correlation in vascular dysfunction, as measured by the VENDYS-II device, with our exosome cargo values. After the patient is consented and enrolled in the study, we will place the device on the patient. The device will be used as outlined by the FDA. Finger sensors will be placed on the pads of the index fingers. The blood pressure cuff will be placed on the arm. Baseline measurement by the device will occur for 5 minutes. After this time, the cuff will inflate and occlude arterial blood flow to one of the arms for 5 minutes. It will then deflate. Temperature measurement will occur for 5 more minutes. Patient participation time in this portion of the study will be 15 minutes. Data collected from the device will be securely stored on our HIPAA-compliant, password-protected research file. Date of birth is a required field for each patient on the device. When the data is extracted from the device, it will be de-identified and linked to the patient's samples only by the study identifier (i.e. C-1, C-2, PE-1, PE-2, etc.). As this device is non-invasive, there is minimal risk to the patient. Risks include discomfort to the arm with the blood pressure cuff. This discomfort could be mild pain around the blood pressure cuff and numbness and tingling in the hand during cuff occlusion. There is also a risk for mild bruising around the cuff site.