Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics (NCT02596165) | Clinical Trial Compass
TerminatedNot Applicable
Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics
Stopped: Stopp because of FDA concrns regarding recruitment.
45 participantsStarted 2016-03
Plain-language summary
The significance of parameters of the central hemodynamic is based upon their strong association with left ventricular hypertrophy and target organ damage at the heart. Noninvasive, auscultatory/ oscillometric and therefore easy applicable measurements of the central hemodynamic such as presented by the Schiller BR-102 plus PWA device implicate highly promising potential for research and daily clinical praxis for improved cardiovascular risk assessment on the population level. The purpose of this study is to evaluate the validity of the central and peripheral blood pressure and central arterial stiffness measured with the device BR-102 plus PWA from Schiller (Schiller AG, Baar, Switzerland).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy individuals free of clinically relevant cardiovascular diseases or diabetes based on medical history and physical examination.
* Heart rhythm: Sinus rhythm
* Blood pressure range: 10 to 12 subjects in each of the three systolic blood pressure (SBP) and three diastolic blood pressure (DBP) recruitment ranges (low, medium, high).
Exclusion Criteria:
* Cardiac arrhythmia (atrial fibrillation, frequent extrasystoles)
* Pacemaker-dependent
* Pregnancy after the 6th month of the pregnancy
* Body mass index (BMI)\>30 kg/m2
* Known significant carotid or femoral artery stenosis
* Impalpable arterial pulse at site of measurement
* Age under 18 years.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.