Back to results

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

Primary Purpose

Syncope, Vasovagal

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

BP monitoring during tilt testing

About this trial

This is an interventional diagnostic trial for Syncope, Vasovagal focused on measuring syncope, tilt table test, blood pressure monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

IRCCS Istituto Auxologico Italiano

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patch monitoring

standard BP monitoring

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

BP drop

Absolute BP values during tilt event with RootiRx and with Finometer

Full Information

NCT ID

NCT05782699

First Posted

March 11, 2023

Last Updated

March 23, 2023

Sponsor

Istituto Auxologico Italiano

1. Study Identification

Unique Protocol Identification Number

NCT05782699

Brief Title

Detecting Syncope by an Integrated Multisensor Patch-type Recorder

Acronym

Patch-VD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

June 25, 2021 (Actual)

Primary Completion Date

May 31, 2022 (Actual)

Study Completion Date

May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Syncope, Vasovagal

Keywords

syncope, tilt table test, blood pressure monitoring

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

patch monitoring

Arm Type

Experimental

Arm Title

standard BP monitoring

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

BP monitoring during tilt testing

Intervention Description

BP measure at various times during tilt testing

Primary Outcome Measure Information:

Title

BP pattern

Description

Difference between baseline (rest) BP and BP at the (pre)syncopal event ("Delta BP slope") during tilt testing with RootiRx and with standard method

Time Frame

2 hours

Secondary Outcome Measure Information:

Title

BP drop

Description

Absolute BP values during tilt event with RootiRx and with Finometer

Time Frame

2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

IRCCS Istituto Auxologico Italiano

City

Milan

State/Province

ZIP/Postal Code

16149

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

Upon reasonable request after the publication of the principal study

IPD Sharing Access Criteria

m.brignole@auxologico.it

Learn more about this trial

Detecting Syncope by an Integrated Multisensor Patch-type Recorder

We'll reach out to this number within 24 hrs