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The Diagnostic Performance of Tilt Test in Athletes

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ClinicalTrials.gov Identifier: NCT02316860
Recruitment Status : Completed
First Posted : December 15, 2014
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Evangelia Kouidi, Aristotle University Of Thessaloniki

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.

Condition or disease Intervention/treatment Phase
Syncope Other: Passive tilt test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Diagnostic Performance of Tilt Test in Athletes and a Novel Strategy for Its Improvement
Study Start Date : October 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
History of reflex syncope
Passive tilt test in athletes with a history of reflex syncope
Other: Passive tilt test
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

No history of reflex syncope
Passive tilt test in athletes without history of reflex syncope
Other: Passive tilt test
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 Measures :
  1. sensitivity and specificity of tilt test in athletes as measured by the occurence of syncope/presyncope during tilt test [ Time Frame: 30 min ]
    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 :
  1. Parameters of haemodynamics during tilt test [ Time Frame: 30 min ]
    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

  2. Parameters of heart rate variability during tilt test [ Time Frame: 30 min ]
    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

  3. Parameters of baroreflex sensitivity during tilt test [ Time Frame: 30 min ]
    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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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316860


Locations
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Greece
Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece
Thessaloniki, Greece, 54622
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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Principal Investigator: Evangelia Kouidi, Professor Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece

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Responsible Party: Evangelia Kouidi, Professor of Sports Medicine-Cardiologist, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT02316860     History of Changes
Other Study ID Numbers: sportscardiology
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms