Detecting Syncope by an Integrated Multisensor Patch-type Recorder

Syncope, Vasovagal Clinical Trial

— Patch-VD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05782699
• Other study ID #: 09C126
• Status: Completed
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syncope
• Syncope, Vasovagal

Intervention

Device:
• BP monitoring during tilt testing
BP measure at various times during tilt testing

Locations

Country	Name	City	State
Italy	IRCCS Istituto Auxologico Italiano	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	BP drop	Absolute BP values during tilt event with RootiRx and with Finometer	2 hours