Syncope Prediction Study (SPS)

February 22, 2019 updated by: Medtronic BRC
The purpose of this study is to perform a prospective evaluation of the vasovagal syncope prediction algorithm, called Tilt Test Analyzer, during head up tilt testing tests in one center in the United Kingdom.

Study Overview

Status

Completed

Conditions

Detailed Description

Vasovagal syncope (VVS) is a form of neurally-mediated reflex syncope, which is marked by a sudden fall in blood pressure with an associated fall in heart rate often resulting in syncope, head-up tilt (HUT) testing is commonly used to bring information about VVS using ECG and blood pressure monitoring with medical observation.

We developed an algorithm, called Tilt Test Analyzer, to predict VVS during HUT based on the simultaneous analysis of heart rate (RR interval), systolic blood pressure (SBP) and an indicator of autonomic modulation represented by heart rate and blood pressure variability (HRV and BPV).

The primary objective of this study is to evaluate the VVS prediction algorithm in a prospective cohort of patients in the tilt laboratory The primary endpoint is the VVS prediction algorithm performance by means of measuring the sensitivity and specificity values.

The study is designed to test if the prospective analysis of tilt-test patients can reproduce the results previously obtained in the published retrospective analysis on 1155 patients with a similar clinically relevant sensitivity and specificity.

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Hammersmith Hospital, Imperial College Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Vasovagal syncope patients

Description

Inclusion Criteria:

  • Patients referred to the center with vasovagal syncope for tilt testing.
  • The patient is willing and able to cooperate with the study procedures.
  • The subject or legal guardian is able to provide written informed consent

Exclusion Criteria:

  • Patients under 18 years or over 90 years old.
  • Women who are currently pregnant or have a positive pregnancy test.
  • Patients who had a prior tilt test.
  • Patients enrolled in another device or drug study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Syncope Prediction
All enrolled patients that performed the tilt table test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of the Syncope Prediction Algorithm
Time Frame: Tilt Test with average duration of 1 hour
Number of tilt-positive participants predicted in the right way by the syncope prediction algorithm
Tilt Test with average duration of 1 hour
Specificity of the Syncope Prediction Algorithm
Time Frame: Tilt Test with average duration of 1 hour
Number of tilt-negative participants identified as negative by the syncope prediction algorithm
Tilt Test with average duration of 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic BRC

Investigators

  • Principal Investigator: P Boon Lim, MD, Hammersmith Hospital, Imperial College Healthcare NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (ESTIMATE)

May 16, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2019

Last Update Submitted That Met QC Criteria

February 22, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Syncope Prediction Study
  • SPS (OTHER: sponsor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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