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iPhone App Compared to Standard Riva-Rocci (RR)-Measurement During Stress Testing (iPARRDeltaBP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860533
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Blood Pressure Device: cuff device Device: iphone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: iPhone App Compared to Standard RR-measurement During Stress Testing
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : February 1, 2017

Arm Intervention/treatment
Experimental: Blood pressure measurement
six repetitive blood pressure measurements with iPhone and conventional oscillometric cuff device during stress testing will be performed
Device: cuff device
Measurement of blood pressure during stress testing with cuff device

Device: iphone
Measurement of blood pressure during stress testing with iPhone




Primary Outcome Measures :
  1. Absolute difference between conventional blood pressure measurements and the corresponding iPhone blood pressure estimations [ Time Frame: 1 day ]
    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


Secondary Outcome Measures :
  1. Number of measurement failures [ Time Frame: 1 day ]
    Number of measurements that cannot be analyzed due to bad signal quality of the Photoplethysmography (PPG) signal



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- able to give informed consent

Exclusion Criteria:

  • atrial fibrillation
  • medical reasons why blood pressure measurement is not possible at the upper extremity (Shunt, Lymphedema)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860533


Locations
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Switzerland
University Hospital Basel
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Jens Eckstein, MD, PhD University Hospital, Basel, Switzerland
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02860533    
Other Study ID Numbers: 2016-00871
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Basel, Switzerland:
Blood pressure
smartphone App
Hypertension
Stress testing
Prevention
Cardiovascular risk factors