- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02316860
The Diagnostic Performance of Tilt Test in Athletes
October 25, 2017 updated by: Evangelia Kouidi, Aristotle University Of Thessaloniki
The Diagnostic Performance of Tilt Test in Athletes and a Novel Strategy for Its Improvement
In the present study the investigators evaluate the sensitivity and specificity of passive tilt test in athletes, as well as their haemodynamic responses and autonomic nervous system activity during head-up tilt.
Moreover, the investigators try to apply a novel algorithm for the improvement of diagnostic yield of tilt test in athletes.
Study Overview
Detailed Description
We examine athletes with a history of reflex syncope and athletes without history of reflex syncope.All subjects undergo a tilt test, for the evaluation of haemodynamics, heart rate variability (HRV) and baroreflex sensitivity.
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Thessaloniki, Greece, 54622
- Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 14-40 years old,
- more than 5 years of exercise training experience and competition at a regional level at different sports
Exclusion Criteria:
- smoking,
- recent alcohol consumption,
- presence of any chronic disease and use of drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: History of reflex syncope
Passive tilt test in athletes with a history of reflex syncope
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Passive tilt test (without pharmacological provocation).
After a horizontal supine rest period of 5 min, the tilt table was inclined at 60° head-up position for 30 min.
A positive response was defined according to the European Society of Cardiology guidelines for the diagnosis and management of syncope
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Other: No history of reflex syncope
Passive tilt test in athletes without history of reflex syncope
|
Passive tilt test (without pharmacological provocation).
After a horizontal supine rest period of 5 min, the tilt table was inclined at 60° head-up position for 30 min.
A positive response was defined according to the European Society of Cardiology guidelines for the diagnosis and management of syncope
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sensitivity and specificity of tilt test in athletes as measured by the occurence of syncope/presyncope during tilt test
Time Frame: 30 min
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sensitivity = number of subjects with syncope/presyncope during tilt test/ number of subjects with a history of reflex syncope, specificity = number of subjects without syncope/presyncope during tilt test/ number of subjects without history of reflex syncope
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30 min
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parameters of haemodynamics during tilt test
Time Frame: 30 min
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We investigate whether the mean values of parameters of haemodynamics during tilt test can discriminate between athletes with a history of reflex syncope and those without history of syncope
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30 min
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Parameters of heart rate variability during tilt test
Time Frame: 30 min
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We investigate whether the mean values of parameters of heart rate variability during tilt test can discriminate between athletes with a history of reflex syncope and those without history of syncope
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30 min
|
Parameters of baroreflex sensitivity during tilt test
Time Frame: 30 min
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We investigate whether the mean values of parameters of baroreflex sensitivity during tilt test can discriminate between athletes with a history of reflex syncope and those without history of syncope
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30 min
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Evangelia Kouidi, Professor, Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
December 6, 2014
First Submitted That Met QC Criteria
December 11, 2014
First Posted (Estimate)
December 15, 2014
Study Record Updates
Last Update Posted (Actual)
October 26, 2017
Last Update Submitted That Met QC Criteria
October 25, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sportscardiology
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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