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| ID | Type | Description | Link |
|---|---|---|---|
| SPS | Other Identifier | sponsor |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Syncope Prediction | All enrolled patients that performed the tilt table test |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of the Syncope Prediction Algorithm | 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 | Number of tilt-negative participants identified as negative by the syncope prediction algorithm | Tilt Test with average duration of 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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Vasovagal syncope patients
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| Name | Affiliation | Role |
|---|---|---|
| P Boon Lim, MD | Hammersmith Hospital, Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Hospital, Imperial College Healthcare NHS Trust | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29715516 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Syncope Prediction Study | All enrolled participants who performed a tilt test. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants included in efficacy analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Syncope Prediction | Enrolled participants who performed tilt test and were included in efficacy analysis |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity of the Syncope Prediction Algorithm | Number of tilt-positive participants predicted in the right way by the syncope prediction algorithm | Number of participants with positive tilt-test | Posted | Count of Participants | Participants | Tilt Test with average duration of 1 hour |
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|
1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Syncope Prediction | Enrolled participants who performed the tilt test | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Phang Boon Lim | Imperial College Healthcare NHS Trust in London, United Kingdom | +44 | (0)20 3313 | p.b.lim@imperial.ac.uk |
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| ID | Term |
|---|---|
| D019462 | Syncope, Vasovagal |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
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| Primary | Specificity of the Syncope Prediction Algorithm | Number of tilt-negative participants identified as negative by the syncope prediction algorithm | Number of participants with negative tilt-test | Posted | Count of Participants | Participants | Tilt Test with average duration of 1 hour |
|
|
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| 140 |
| 0 |
| 140 |
| 0 |
| 140 |
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| D013575 | Syncope |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |