Detecting Syncope by an Integrated Multisensor Patch-type Recorder (Patch-VD)

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

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.

Study Overview

• Status: Completed
• Conditions: Syncope, Vasovagal
• Intervention / Treatment: Device: BP monitoring during tilt testing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 16149
      • IRCCS Istituto Auxologico Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patch monitoring	Device: BP monitoring during tilt testing; BP measure at various times during tilt testing
Active Comparator: standard BP monitoring	Device: BP monitoring during tilt testing; BP measure at various times during tilt testing

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Collaborators: Antonella Groppelli

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: March 11, 2023
• First Submitted That Met QC Criteria: March 11, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: syncope; blood pressure monitoring; tilt table test
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Syncope; Syncope, Vasovagal
• Other Study ID Numbers: 09C126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Upon reasonable request after the publication of the principal study
• IPD Sharing Access Criteria: m.brignole@auxologico.it
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No