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Trial record 8 of 42 for:    Syncope | Child

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

Tracking Information
First Submitted Date  ICMJE December 6, 2014
First Posted Date  ICMJE December 15, 2014
Last Update Posted Date October 26, 2017
Study Start Date  ICMJE October 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02316860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Diagnostic Performance of Tilt Test in Athletes
Official Title  ICMJE The Diagnostic Performance of Tilt Test in Athletes and a Novel Strategy for Its Improvement
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Syncope
Intervention  ICMJE 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
Study Arms  ICMJE
  • History of reflex syncope
    Passive tilt test in athletes with a history of reflex syncope
    Intervention: Other: Passive tilt test
  • No history of reflex syncope
    Passive tilt test in athletes without history of reflex syncope
    Intervention: Other: Passive tilt test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2014)
140
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02316860
Other Study ID Numbers  ICMJE sportscardiology
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Evangelia Kouidi, Aristotle University Of Thessaloniki
Study Sponsor  ICMJE Aristotle University Of Thessaloniki
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Evangelia Kouidi, Professor Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece
PRS Account Aristotle University Of Thessaloniki
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP