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van CCT (UK)


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van CCT (UK)


Validation and comparison of four smartphone-connected blood pressure monitors


- candidate number22273
- NTR NumberNTR5241
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-jun-2015
- Secondary IDsNL52863.058.15 
- Public TitleValidation and comparison of four smartphone-connected blood pressure monitors
- Scientific TitleValidation and comparison of four smartphone-connected blood pressure monitors
- ACRONYMnot applicable
- hypothesisWe hypothesize that the accuracy of four selected types of smartphone compatible blood pressure monitors does not differ significantly from the handheld sphygmanometer
- Healt Condition(s) or Problem(s) studied
- Inclusion criteriaPatients 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 criteriaPatients with diagnosed irregular cardiac arrhythmias
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 28-mei-2015
- planned closingdate31-jul-2015
- Target number of participants43
- InterventionsFour smartphone compatible blood pressure monitors:
- iHealth BP 5
- iHealth BP 7
- QardioArm
- Withings Blood Pressure Monitor
- Primary outcomeAll measured blood pressures by all devices
- Secondary outcomenot applicable
- Timepointsnot applicable
- Trial web sitenot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Roderick Treskes
- CONTACT for SCIENTIFIC QUERIES Roderick Treskes
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
- Publicationsnot applicable
- Brief summaryRationale: 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).
- Main changes (audit trail)
- RECORD1-jun-2015 - 15-aug-2015


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