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Syncope Prediction Study (SPS)

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ClinicalTrials.gov Identifier: NCT02140567
Recruitment Status : Completed
First Posted : May 16, 2014
Results First Posted : August 27, 2018
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic BRC

Brief Summary:
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.

Condition or disease
Vasovagal Syncope

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.


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Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Syncope Prediction Study
Study Start Date : November 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

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



Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Vasovagal syncope patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140567


Locations
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United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom
Sponsors and Collaborators
Medtronic BRC
Investigators
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Principal Investigator: P Boon Lim, MD Hammersmith Hospital, Imperial College Healthcare NHS Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT02140567     History of Changes
Other Study ID Numbers: Syncope Prediction Study
SPS ( Other Identifier: sponsor )
First Posted: May 16, 2014    Key Record Dates
Results First Posted: August 27, 2018
Last Update Posted: March 15, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases