No registrations found.
ID
Source
Brief title
Health condition
Not applicable
Sponsors and support
Intervention
Outcome measures
Primary outcome
All measured blood pressures by all devices
Secondary outcome
not applicable
Background summary
Rationale: Smartphone-connected blood pressure monitors are being released on the market. An independent study comparing the accuracy of these devices has not been done yet.
Objective: To validate and compare smartphone-connected blood pressure monitors produced by Withings, Qardio and iHealth with the gold standard and a validated automatic blood pressure monitor.
Study design: Crossover trial
Study population: Two study populations will be investigated. The first population (population one) will consists of young, healthy individuals aged 18-30. The second population (population two) will consist of patients who visit the outpatient clinic within one year after having suffered from a ST elevation myocardial infarction for which they received primary percutaneous coronary intervention in the LUMC.
Intervention: All study subjects will receive three blood pressure measurements with a handheld manometer, three measurements with an automatic device and 12 measurements with 4 automatic devices (1 device will be used 3 times in 1 patient). The order in which the devices are used will be randomized
Main study parameters/endpoints: The study parameter will be per study subject 18 systolic blood pressure measurements (SBP), 18 diastolic blood pressure measurements (DBP) and 18 heart rates (HR).
Study objective
We hypothesize that the accuracy of four selected types of smartphone compatible blood pressure monitors does not differ significantly from the handheld sphygmanometer
Study design
not applicable
Intervention
Four smartphone compatible blood pressure monitors:
- iHealth BP 5
- iHealth BP 7
- QardioArm
- Withings Blood Pressure Monitor
Inclusion criteria
Patients with a ST-elevation myocardial infarction and subsequently primary percutaneous coronary intervention (PCI) one year or less ago at the time of their outpatient clinic visit.
Exclusion criteria
Patients with diagnosed irregular cardiac arrhythmias
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5109 |
| NTR-old | NTR5241 |
| CCMO | NL52863.058.15 |
| OMON | NL-OMON42703 |