Vasovagal SyncopeSPSNCT02140567

Syncope Prediction Study

An observational study of Vasovagal Syncope, run by Medtronic BRC at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Vasovagal Syncope
How many people: 140 participants
Where: 1 siteUnited Kingdom
Study dates: Nov 2014to Nov 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Vasovagal syncope patients

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Hammersmith Hospital, Imperial College Healthcare NHS Trust
London

Other trials in United Kingdom

About this study

Read the 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.

Conditions: Vasovagal Syncope
Medical subject headings: Syncope, Vasovagal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02140567
Study group	Role	What they receive
Syncope Prediction		All enrolled patients that performed the tilt table test

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Nov 2016

First posted16 May 2014 (estimated)
Study startNov 2014
Primary completionOct 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Vasovagal SyncopeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02140567
Sponsor's protocol ID: Syncope Prediction Study
Other IDs: SPS
Acronym: SPS
Status last verified: Feb 2019
First submitted: 30 Apr 2014
Last updated: 15 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Virag N, Erickson M, Taraborrelli P, Vetter R, Lim PB, Sutton R. Predicting vasovagal syncope from heart rate and blood pressure: A prospective study in 140 subjects. Heart Rhythm. 2018 Sep;15(9):1404-1410. doi: 10.1016/j.hrthm.2018.04.032. Epub 2018 Apr 30.
PubMed 29715516

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Syncope, Vasovagal
RecruitingObservational study
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Arrhythmias, Cardiac
Recruiting
Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial
Colorectal Neoplasia, Screening Colonoscopy
Active, not recruitingObservational study
A Warning Red Flag Classification System to Predict Risk of Vasovagal Event During Office Hysteroscopy
Vasovagal Syncope (VVS), Presyncope

All Vasovagal Syncope trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Syncope Prediction Study
ClinicalTrials.gov ID: NCT02140567
Acronym / sponsor ID: SPS / Syncope Prediction Study
Conditions: Vasovagal Syncope
Study type: Observational
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Medtronic BRCIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Oct 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 16 May 2014 (estimated)
Results: Posted 27 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Syncope Prediction	–	–All enrolled patients that performed the tilt table test

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Vasovagal syncope patients

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

Results and safety

Results posted to the registry on 27 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Syncope Prediction Study	140	134

Primary outcome: Sensitivity of the Syncope Prediction Algorithm

Time frame: Tilt Test with average duration of 1 hour. Count of participants. Unit: Participants

Measure	Syncope Prediction (Sensitivity) n = 83
True positive	81
False negative	2

Population analysed: Number of participants with positive tilt-test

Primary outcome: Specificity of the Syncope Prediction Algorithm

Time frame: Tilt Test with average duration of 1 hour. Count of participants. Unit: Participants

Measure	Syncope Prediction (Specificity) n = 51
True negative	45
False positive	6

Population analysed: Number of participants with negative tilt-test

Adverse events

Time frame: 1 hour. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Syncope Prediction	0 of 140 (0%)	0 of 140 (0%)	0 of 140

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29715516Virag N, Erickson M, Taraborrelli P, Vetter R, Lim PB, Sutton R. Predicting vasovagal syncope from heart rate and blood pressure: A prospective study in 140 subjects. Heart Rhythm. 2018 Sep;15(9):1404-1410. doi: 10.1016/j.hrthm.2018.04.032. Epub 2018 Apr 30.

Related trials for Vasovagal Syncope

RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Syncope, Vasovagal
RecruitingObservational study
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Arrhythmias, Cardiac
Recruiting
Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial
Colorectal Neoplasia, Screening Colonoscopy
Active, not recruitingObservational study
A Warning Red Flag Classification System to Predict Risk of Vasovagal Event During Office Hysteroscopy
Vasovagal Syncope (VVS), Presyncope

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

P Boon Lim, MD principal investigator

Hammersmith Hospital, Imperial College Healthcare NHS Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Vasovagal Syncope, run by Medtronic BRC at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of the Syncope Prediction Algorithm (time frame: Tilt Test with average duration of 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02140567, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.