Trial Outcomes & Findings for Syncope Prediction Study (NCT NCT02140567)

Results Overview

Number of tilt-positive participants predicted in the right way by the syncope prediction algorithm

Recruitment status

COMPLETED

Target enrollment

140 participants

Primary outcome timeframe

Tilt Test with average duration of 1 hour

Results posted on

2019-03-15

Participant milestones
Measure	Syncope Prediction Study All enrolled participants who performed a tilt test.
Overall Study STARTED	140
Overall Study COMPLETED	134
Overall Study NOT COMPLETED	6

Reasons for withdrawal
Measure	Syncope Prediction Study All enrolled participants who performed a tilt test.
Overall Study Problems with recording equipment	6

Syncope Prediction Study

Baseline characteristics by cohort
Measure	Syncope Prediction n=134 Participants Enrolled participants who performed tilt test and were included in efficacy analysis
Age, Continuous	37.2 years STANDARD_DEVIATION 15.1 • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants

Timeframe: Tilt Test with average duration of 1 hour

Population: Number of participants with positive tilt-test

Number of tilt-positive participants predicted in the right way by the syncope prediction algorithm

Outcome measures
Measure	Syncope Prediction (Sensitivity) n=83 Participants Tilt-positive participants included in the efficacy analysis
Sensitivity of the Syncope Prediction Algorithm True positive	81 Participants
Sensitivity of the Syncope Prediction Algorithm False negative	2 Participants

Timeframe: Tilt Test with average duration of 1 hour

Population: Number of participants with negative tilt-test

Number of tilt-negative participants identified as negative by the syncope prediction algorithm

Outcome measures
Measure	Syncope Prediction (Sensitivity) n=51 Participants Tilt-positive participants included in the efficacy analysis
Specificity of the Syncope Prediction Algorithm True negative	45 Participants
Specificity of the Syncope Prediction Algorithm False positive	6 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Imperial College Healthcare NHS Trust in London, United Kingdom

Phone: +44