iPhone App Compared to Standard Riva-Rocci (RR)-Measurement During Stress Testing
iPARRDeltaBP
1 other identifier
interventional
220
1 country
1
Brief Summary
The iPARR DELTA BP Study is designed to evaluate whether a new smartphone app using the photoplethysmography signal of the inbuilt camera can measure blood pressure (BP) fluctuations with sufficient correlation compared to the goldstandard oscillometric BP measurements. Investigators will recruit patients who are scheduled for a routine treadmill stress test and assess their blood pressure before and right after the test with the smartphone app and the standard BP measurements on the opposite upper extremity. Pronounced BP fluctuations are encountered during vigorous activities. The primary endpoint of the iPARR DELTA BP Study is the correlation of the absolute difference of subsequent measurements between both techniques. If the relative chances of BP fluctuations are sufficiently assessed with this new device, BP fluctuations could be monitored continuously after calibration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
August 9, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMay 7, 2019
May 1, 2019
5 months
July 20, 2016
May 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute difference between conventional blood pressure measurements and the corresponding iPhone blood pressure estimations
Difference between the delta of two sequential oscillometric measurements and the delta of the two corresponding blood pressure estimates calculated from the PPG signal of an iPhone 4S
1 day
Secondary Outcomes (1)
Number of measurement failures
1 day
Study Arms (1)
Blood pressure measurement
EXPERIMENTALsix repetitive blood pressure measurements with iPhone and conventional oscillometric cuff device during stress testing will be performed
Interventions
Measurement of blood pressure during stress testing with cuff device
Measurement of blood pressure during stress testing with iPhone
Eligibility Criteria
You may qualify if:
- \- able to give informed consent
You may not qualify if:
- atrial fibrillation
- medical reasons why blood pressure measurement is not possible at the upper extremity (Shunt, Lymphedema)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Basel
Basel, Canton of Basel-City, 4031, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens Eckstein, MD, PhD
University Hospital, Basel, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2016
First Posted
August 9, 2016
Study Start
September 1, 2016
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
May 7, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share