NCT02316860

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

December 6, 2014

Last Update Submit

October 25, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    30 min

Secondary Outcomes (3)

  • Parameters of haemodynamics during tilt test

    30 min

  • Parameters of heart rate variability during tilt test

    30 min

  • Parameters of baroreflex sensitivity during tilt test

    30 min

Study Arms (2)

History of reflex syncope

OTHER

Passive tilt test in athletes with a history of reflex syncope

Other: Passive tilt test

No history of reflex syncope

OTHER

Passive tilt test in athletes without history of reflex syncope

Other: Passive tilt test

Interventions

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

History of reflex syncopeNo history of reflex syncope

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old,
  • more than 5 years of exercise training experience and competition at a regional level at different sports

You may not qualify if:

  • smoking,
  • recent alcohol consumption,
  • presence of any chronic disease and use of drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Thessaloniki, 54622, Greece

Location

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Evangelia Kouidi, Professor

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Sports Medicine-Cardiologist

Study Record Dates

First Submitted

December 6, 2014

First Posted

December 15, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations