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The Diagnostic Performance of Tilt Test in Athletes

Primary Purpose

Syncope

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Passive tilt test
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Syncope

Eligibility Criteria

14 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

History of reflex syncope

No history of reflex syncope

Arm Description

Passive tilt test in athletes with a history of reflex syncope

Passive tilt test in athletes without history of reflex syncope

Outcomes

Primary Outcome Measures

sensitivity and specificity of tilt test in athletes as measured by the occurence of syncope/presyncope during tilt test
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

Secondary Outcome Measures

Parameters of haemodynamics during tilt test
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
Parameters of heart rate variability during tilt test
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
Parameters of baroreflex sensitivity during tilt test
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

Full Information

First Posted
December 6, 2014
Last Updated
October 25, 2017
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT02316860
Brief Title
The Diagnostic Performance of Tilt Test in Athletes
Official Title
The Diagnostic Performance of Tilt Test in Athletes and a Novel Strategy for Its Improvement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
History of reflex syncope
Arm Type
Other
Arm Description
Passive tilt test in athletes with a history of reflex syncope
Arm Title
No history of reflex syncope
Arm Type
Other
Arm Description
Passive tilt test in athletes without history of reflex syncope
Intervention Type
Other
Intervention Name(s)
Passive tilt test
Intervention Description
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
Primary Outcome Measure Information:
Title
sensitivity and specificity of tilt test in athletes as measured by the occurence of syncope/presyncope during tilt test
Description
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
Time Frame
30 min
Secondary Outcome Measure Information:
Title
Parameters of haemodynamics during tilt test
Description
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
Time Frame
30 min
Title
Parameters of heart rate variability during tilt test
Description
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
Time Frame
30 min
Title
Parameters of baroreflex sensitivity during tilt test
Description
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
Time Frame
30 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evangelia Kouidi, Professor
Organizational Affiliation
Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

The Diagnostic Performance of Tilt Test in Athletes

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