Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement (VAST)
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ClinicalTrials.gov Identifier: NCT03054688 |
Recruitment Status :
Completed
First Posted : February 15, 2017
Last Update Posted : June 15, 2018
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Sponsor:
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
Tracking Information | |||||||
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First Submitted Date ICMJE | February 13, 2017 | ||||||
First Posted Date ICMJE | February 15, 2017 | ||||||
Last Update Posted Date | June 15, 2018 | ||||||
Actual Study Start Date ICMJE | April 25, 2017 | ||||||
Actual Primary Completion Date | March 1, 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Difference in mean 24h systolic blood pressure [ Time Frame: 24 hours ] Difference in mean 24h systolic blood pressure
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Original Primary Outcome Measures ICMJE |
Difference in mean 24h systolic blood pressure [ Time Frame: 24 hours ] | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement | ||||||
Official Title ICMJE | Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement | ||||||
Brief Summary | Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Blood Pressure | ||||||
Intervention ICMJE | Device: Somnotouch NIBP
Somnotouch NIBP in addition to standard blood pressure measurement
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Study Arms ICMJE | Experimental: Somnotouch NIBP
Blood pressure measurement with Somnotouch-NIBP device in addition to standard cuff based device
Intervention: Device: Somnotouch NIBP
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Publications * | Krisai P, Vischer AS, Kilian L, Meienberg A, Mayr M, Burkard T. Accuracy of 24-hour ambulatory blood pressure monitoring by a novel cuffless device in clinical practice. Heart. 2019 Mar;105(5):399-405. doi: 10.1136/heartjnl-2018-313592. Epub 2018 Sep 18. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
83 | ||||||
Original Estimated Enrollment ICMJE |
50 | ||||||
Actual Study Completion Date ICMJE | April 1, 2018 | ||||||
Actual Primary Completion Date | March 1, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 25 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Switzerland | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03054688 | ||||||
Other Study ID Numbers ICMJE | 03061989 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | University Hospital, Basel, Switzerland | ||||||
Original Responsible Party | Thilo Burkard, University Hospital, Basel, Switzerland, Dr. med. | ||||||
Current Study Sponsor ICMJE | University Hospital, Basel, Switzerland | ||||||
Original Study Sponsor ICMJE | Thilo Burkard | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | University Hospital, Basel, Switzerland | ||||||
Verification Date | June 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |