Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT03126994
Eligibility Criteria:
Inclusion Criteria:
* Subjects \>18 years old
* Subject signs a written Informed Consent form to participate in the study, prior to any study procedures
Subgroup Inclusion Criteria
* Subject has been taking ACE Inhibitors or Angiotensin Receptor Blockers for at least 30 days
Exclusion Criteria:
* Known significant carotid or femoral artery stenosis
* Non-palpable (non-detectable) arterial pulse at the sites of measurements
* Pacemaker, defibrillator, or other cardiac stimulator
* Erratic, accelerated or mechanically controlled irregular heart rhythm, or an arrhythmia
* History of cardiac valve disorder or cardiac valve disease
* History of venous disease, including venous insufficiency or deep vein thrombosis
* History of peripheral artery disease
* Requirement for supplemental oxygen
* Neuromuscular disorders that cause shaking or tremors (such as Parkinson's disease or Multiple Sclerosis), or other disease or condition affecting balance
* Amputation or malformation of any limb or extremity (foot, leg, or arm) which would impede the placement of blood pressure cuffs or standing on the scale with two feet.
* Known or suspected pregnancy
* Inability to provide informed consent
* Mental incompetence or a prisoner status
* Current participation in a clinical trial of another investigational drug or device in which the study endpoint has not been met
* BMI \> 40
* Subjects \> 400 lbs
* Subjects on strong vasoactive drugs, such as those used to control high blood pressure, for \<30 days
* Blood loss or blood donation of ˃ 550 mL within 30 days before study procedure
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03126994
Study Brief:
Protocol Section:
NCT03126994