Syncope Prediction Study (SPS)
|ClinicalTrials.gov Identifier: NCT02140567|
Recruitment Status : Completed
First Posted : May 16, 2014
Results First Posted : August 27, 2018
Last Update Posted : March 15, 2019
|Condition or disease|
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|
|Actual Enrollment :||140 participants|
|Official Title:||Syncope Prediction Study|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||November 2016|
All enrolled patients that performed the tilt table test
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140567
|Hammersmith Hospital, Imperial College Healthcare NHS Trust|
|London, United Kingdom|
|Principal Investigator:||P Boon Lim, MD||Hammersmith Hospital, Imperial College Healthcare NHS Trust|