Assessment of Three Instruments for the Non-invasive Measurement of Arterial Stiffness. (ASI-2012)
Healthy, Diabetes Type 2, Obesity
About this trial
This is an interventional screening trial for Healthy focused on measuring Pulse Wave Analysis, Arterial Stiffness
Eligibility Criteria
Inclusion Criteria:
Participants of the Healthy Group must meet the following criteria to be eligible for participation in the study:
- Healthy male or female, greater or equal to 20 and less than or equal to 70 years of age;
- Willing to comply with the protocol requirements;
- Willing to provide informed consent.
Participants of the Obese/Type 2 Diabetes Group must meet the following criteria to be eligible for participation in the study:
- Male or female, greater or equal to 20 and less than or equal to 70 years of age;
- Presence of clinically diagnosed Type 2 Diabetes, and/or a body mass index (BMI) > 30;
- Willing to comply with the protocol requirements;
- Willing to provide informed consent.
Participants of the Vascular Disease Group must meet the following criteria to be eligible for participation in the study:
- Male or female, greater or equal to 20 and less than or equal to 70 years of age;
Documented evidence of atherosclerosis as manifested by one of the following:
- documented myocardial infarction;
- documented CAD as defined as >70% stenosis of an epicardial coronary artery;
- documented PAD including those with claudication as defined by an ankle brachial index of <0.9;
- angiographically documented carotid or lower limb stenosis of >50%
- Willing to comply with the protocol requirements;
- Willing to provide informed consent -
Exclusion Criteria:
Participants of the Healthy Group will be excluded if they have any of the following:
- Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
- Cigarette/cigar smoking, current or within the last 6 months;
- Current (within the last 30 days) bacterial, viral or fungal infection;
- Taking any prescribed medication (with the exception of birth control or HRT) within the last 3 months or over-the-counter medication within the past 72 h;
- Pregnancy;
- Amputation or malformation of any limb or extremity (fingers, leg, or arm) which would impede the placement of sensors, probes, or blood pressure cuffs.
Participants of the Obese/Type 2 Diabetes Group will be excluded if they have any of the following:
Documented evidence of atherosclerosis as manifested by one of the following:
- documented myocardial infarction;
- documented CAD as defined as >70% stenosis of an epicardial coronary artery;
- documented PAD including those with claudication as defined by an ankle brachial index of <0.9;
- angiographically documented carotid or lower limb stenosis of >50%
- having had a documented previous intervention for CAD or PAD.
- Cigarette/cigar smoking, current or within the last 6 months;
- Current (within the last 30 days) bacterial, viral or fungal infection;
- Taking over-the-counter medication within the past 72 h;
- Pregnancy;
- Amputation or malformation of any limb or extremity (fingers, leg, or arm) which would impede the placement of sensors, probes, or blood pressure cuffs.
Participants of the Vascular Disease Group will be excluded if they have any of the following:
- Cigarette/cigar smoking, current or within the last 6 months;
- Current (within the last 30 days) bacterial, viral or fungal infection;
- Taking over-the-counter medication within the past 72 h;
- Pregnancy;
- Amputation or malformation of any limb or extremity (fingers, leg, or arm) which would impede the placement of sensors, probes, or blood pressure cuffs.
- Having had a documented previous intervention for CAD or PAD
Sites / Locations
- St. Boniface General Hospital - Asper Clinical Research Institute
Arms of the Study
Arm 1
Experimental
ASI Device
Study Participants will attend the research clinic one time (one visit) for the vascular testing. Each instrument/assessment will be run sequentially starting with the Arterial Stiffness Screening Device, then followed by SphygmoCor system, which will then be followed by the CR-2000 CV Profiler, then finally the VP-1000.