Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02316860
Other study ID # sportscardiology
Secondary ID
Status Completed
Phase N/A
First received December 6, 2014
Last updated October 25, 2017
Start date October 2014
Est. completion date December 2014

Study information

Verified date October 2017
Source Aristotle University Of Thessaloniki
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Greece Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece Thessaloniki

Sponsors (1)

Lead Sponsor Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 30 min
Secondary 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 30 min
Secondary 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 30 min
See also
  Status Clinical Trial Phase
Completed NCT06038708 - Head-up Tilt Test in Patients With Reflex Syncope and Asystolic Response Who Received a Dual-chamber Pacemaker With the Closed Loop Stimulation (CLS) and Participated in the BIOSync Trial
Completed NCT00069693 - Evaluation of Chronic Orthostatic Intolerance N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Completed NCT02565238 - BIO.MASTER.BioMonitor 2 Study N/A
Active, not recruiting NCT01965899 - Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System N/A
Completed NCT00746564 - Study of New Implantable Loop Recorder N/A
Completed NCT00359203 - ISSUE3: International Study on Syncope of Uncertain Etiology 3 Phase 4
Recruiting NCT04972071 - SW-RCT Implementation of Canadian Syncope Risk Score Based Practice Recommendations N/A
Completed NCT04198220 - BIO|STREAM.ICM Obesity
Recruiting NCT04533425 - Practical Approaches to Care in Emergency Syncope
Completed NCT05571254 - The Management of Transient Loss of Consciousness and Suspected Syncope in European Emergency Departments
Recruiting NCT05621460 - The Effect of Water Carbonation on Orthostatic Tolerance N/A
Not yet recruiting NCT05957315 - Mobile Cardiac Outpatient Telemetry for Unexplained Syncope N/A
Recruiting NCT04615065 - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Completed NCT05729724 - Effect of Pharmacological Interventions on Systolic Blood Pressure Drops (SynABPM 2 Proof-of-concept)
Completed NCT05782712 - Rapid Measurement of Adenosine in Syncope Patients
Completed NCT03786640 - Abbott Brady 3T MRI PMCF
Recruiting NCT03803969 - ConfirmRxTM: Posture and Activity N/A
Recruiting NCT05575934 - Management of Transitory Loss of Consciousness and Syncopes in the Emergency Department
Recruiting NCT04075084 - Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)