DIVISION OF PODIATRY
CAVI Healthy Subject Data Collection Study

 

Click below for information about the study:

 

  • Who is conducting this study?


    Principal Investigator


    The Principal Investigator (PI) is the researcher directing this study; the PI is responsible for protecting your rights, safety and welfare as a participant in the research.  The PI for this study is Michael G. Palladino, DPM, of the University of Texas Health Science Center at San Antonio Department of Orthopaedics, Podiatry Division.

    Study Sponsor:   Fukuda Denshi U.S.A., Inc.

    For-Profit Sponsor
    Fukuda Denshi U.S.A., Inc., a for-profit company, is funding this study (the sponsor).  The sponsor designed the CAVI Healthy Subject Data Collection study, drafted the study plan and is providing the VaSera device to UTHSCSA so that the researchers can conduct the study.

  • Why are you doing this study?

     

    The VaSera is an FDA-cleared device that measures CAVI, an indicator of arterial stiffness. Research studies have shown that arterial stiffness can be linked to a number of health problems, including strokes, kidney failure, and deaths from heart disease. The VaSera has been used in Japan for more than 10 years, but is new in the United States, and there have been no studies performed to find out if CAVI values for healthy adults in the U.S. are the same as CAVI values for healthy adults in Japan. Sometimes measurements like CAVI can be different between groups of people of different ethnic or racial backgrounds, so in order to be able to know what CAVI values are abnormal, or suggest possible health problems, we must first find out what values are normal for healthy people.

     

    The researchers hope to learn whether CAVI values for healthy adults in the U.S. are the same or different from CAVI values for healthy adults in Japan. In addition, the researchers hope to be able to compare CAVI values of healthy Latinos and healthy non-Latinos, to find out if there is any difference in normal CAVIs of these groups.

  • What will happen if I choose to participate?

    While you are taking part in this study, you will be asked to attend 1 visit with the researchers or study staff.

    Screening Procedures
    You will be asked to complete a 37-question screening questionnaire.  The results of the screening questionnaire will be reviewed to determine whether you will be allowed to continue in the study.  If you are not allowed to continue in the study, the researcher will discuss the reasons with you. If you are allowed to continue in the study, the details of the study will be discussed with you, and you will be asked to sign a research consent document. If you sign a consent, the answers you provided on the Screening Questionnaire will be included in the study data with your VaSera results. If you decide not to participate, we will not record your answers in the study data — you may keep your completed questionnaire, or we will destroy it for you.

    Study Procedures - as a participant, you will undergo the following procedures. All of the procedures are being done solely for research purposes.
    • We will measure your height and weight
    • We will use the VaSera device to determine your ABI and CAVI
    • You will be asked to remove your shoes and socks
    • The chair in the exam room will be reclined flat
    • We will place blood pressure cuffs around both of your arms, both of your ankles, and both of your second toes (the toes next to the big toes)
    • We will place a clip on each wrist that senses the electrical activity of your heart (EKG)
    • We will place a small microphone on your chest, on the breastbone. This microphone is held in place with a piece of sticky tape
    • You will be asked to lie still and remain quiet while the test is being performed
    • As the test is performed, the various blood pressure cuffs will inflate and deflate several times in different patterns. If the data obtained by the device is poor in the first part of the test we may have to stop the test to readjust the blood pressure cuffs, then restart the test from the beginning.
    • Once the test is complete, we will remove the microphone, clips, and blood pressure cuffs. Removal of the tape securing the chest microphone may be briefly mildly painful, particularly if you have hair on your chest. We will tell you your results, and how your results compare to the Japanese standards for adults of your age and gender. Because there are no U.S. standards for this device, and we do not know if U.S. standards will differ from the Japanese standards, the comparison of your results to Japanese results has limited medical value.

    The entire test will typically take less than 10 minutes; it may be slightly longer if we have to readjust the cuffs due to poor initial readings.
  • Are there any risks?

    Risks from the VaSera test


    There are risks to taking part in this research study, but none of the risks are either likely or serious:
    • You may experience some discomfort when the blood pressure cuffs inflate. If you feel that this discomfort is too great, tell the researchers and we will stop the test. Discomfort is most likely in subjects with unusually large arms.
    • The microphone that will be placed on your chest is held in place with a piece of sticky tape. You may experience pulling of your skin or chest hair as the microphone is removed at the end of the test. It is also possible that the adhesive could cause skin irritation, but this does not normally occur.
    • You may experience some distress if your test results suggest that you may have problems with your cardiovascular system that you were not previously aware of. If you do receive unexpected results we strongly encourage you to follow up with your physician for diagnosis and/or management.

     For more information about risks, ask one of the researchers or study staff.
  • Will I receive any direct benefits from participating in the study?

    You may not receive any personal benefits from being in this study.

    We hope the information learned from this study will benefit other people with diseases related to arterial stiffness in the future.
  • Will I be paid to participate?

    You will be compensated $25 for your time and travel. A check for the compensation will be mailed to you in about 2-4 weeks.
    Please note that if you are on record as owing money to the State of Texas, such as for back child support or a delinquent student loan, the payment may be applied to that debt and you may not receive a check.

  • Where can I find more information about the sponsor, Fukuda Denshi U.S.A., Inc., and the VaSera device?

    Complete a pre-screening questionnaire to find out if you might be eligible and to send your contact information to the research team

    First, calculate your body mass index (BMI), and write down or remember the result:


    Body Mass Index
        


     

    Then, complete the pre-screening questionnaire to find out if you could be eligible to participate.

 

Spread the word!

If you have friends, family members, or followers who would be interested in participating in this research study, please tell them about it. 

Email Facebook Twitter Google+ Addthis

 

Study Flyer

If you have further questions about the study, please contact:

Krista Kilpadi, PhD at Kilpadi@uthscsa.edu
The University of Texas Health Science Center at San Antonio
Department of Orthopaedics
7703 Floyd Curl Drive
Mail Code 7774
San Antonio, TX 78229
(210) 567-6292


The University of Texas Health Science Center at San Antonio is committed to conducting research in a way that protects your safety and promotes your rights and welfare. The Health Science Center has established a committee to review research involving human subjects. This committee is called the Institutional Review Board (or IRB). If you have any questions, concerns or complaints you can contact the Director of the IRB:


Director, IRB
The University of Texas Health Science Center at San Antonio
Mail Code 7830
7703 Floyd Curl Drive
San Antonio, TX 78229-3900
210-567-8250
IRBmail@uthscsa.edu