Detecting Syncope by an Integrated Multisensor Patch-type Recorder

Study Overview
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Brief Summary
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The main purpose of this study is to assess the reliability of a new cuffless patch BP monitor in detecting episodes of hypotensive (pre)syncope during tilt testing.

Detailed Description
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Background While ECG monitoring is a reliable and established method that allows to document bradycardia in a substantial proportion of patients affected by cardioinhibitory reflex syncope, the documentation of a transient hypotension is only seldom achieved in patients affected by hypotensive syncope. Conventional ambulatory blood pressure (BP) monitoring (ABPM) has important limitations due to the short period of monitoring (usually 24-48 hours) and the intermittent nature of BP measurements (usually every 15-20 min). The main purpose of this study is to assess the reliability of a new cuffless patch BP monitor in detecting episodes of hypotensive (pre)syncope. Secondary aim regards the estimation of feasibility of this tool. Method The study is a prospective intrapatient comparison between BP measured by mean of a cuffless patch BP monitor (RootiRX System, Rooti Labs Ltd., Taipei, Taiwan) and by mean of the standard method during tilt testing. Study design BP values observed during tilt testing baseline and at the time of impeding syncope will be measured by mean of the RootiRX device and will be compared with the standard of reference. BP will be recorded at rest at baseline, shortly after upright in tilting position (at stabilization), at the time of occurrence of syncope (presyncope) or, alternatively at the time of maximum hypotensive effect, if syncope will not occur, and finally in the recovery period at the end of the test after returning in supine position.

Official Title
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Detection of Impending Reflex Syncope by Means of an Integrated Multisensor Patch-type Recorder

Conditions
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Syncope, Vasovagal

Intervention / Treatment
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* Device: BP monitoring during tilt testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients, >18 years of age, referred for tilt testing because affected by suspected reflex syncope Exclusion Criteria: Incapability to perform tilt testing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patch monitoring<br> | Device: BP monitoring during tilt testing<br>* BP measure at various times during tilt testing<br>|
| Active Comparator: standard BP monitoring<br> | Device: BP monitoring during tilt testing<br>* BP measure at various times during tilt testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BP pattern | Difference between baseline (rest) BP and BP at the (pre)syncopal event (Delta BP slope) during tilt testing with RootiRx and with standard method | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BP drop | Absolute BP values during tilt event with RootiRx and with Finometer | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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syncope, tilt table test, blood pressure monitoring