Detecting Syncope by an Integrated Multisensor Patch-type Recorder

NCT ID: NCT05782699

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-25
• Study Completion Date: 2022-05-31

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.

Conditions

Syncope, Vasovagal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patch monitoring

Group Type: EXPERIMENTAL

BP monitoring during tilt testing

Intervention Type: DEVICE

BP measure at various times during tilt testing

standard BP monitoring

Group Type: ACTIVE_COMPARATOR

BP monitoring during tilt testing

Intervention Type: DEVICE

BP measure at various times during tilt testing

Interventions

BP monitoring during tilt testing

BP measure at various times during tilt testing

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Michele Brignole

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Istituto Auxologico Italiano

Milan, MI, Italy

Countries

Italy

Other Identifiers

09C126

Identifier Type: -

Identifier Source: org_study_id