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Normal Values of High Frequency ECG (HyperQ™) in Apparently Healthy Individuals and in Young and Masters Athletes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by BSP Biological Signal Processing Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
BSP Biological Signal Processing Ltd.
ClinicalTrials.gov Identifier:
NCT00847353
First received: February 18, 2009
Last updated: February 3, 2010
Last verified: February 2010
History of Changes
  Purpose

The main objective of this study is to investigate depolarization characteristics represented by changes in HyperQ in asymptomatic, apparently healthy athletic and non-athletic individuals. We also aim to examine a subgroup of obese and non-obese subjects. The goal of the study is to establish normal HyperQ values in these populations and compare HyperQ values of age-matched athletic vs. non-athletic individuals of similar health status.


Condition
Healthy
Asymptomatic
Obesity

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Normal Values of High Frequency ECG (HyperQ™) in Asymptomatic, Apparently Healthy Normal Weight vs. Obese Individuals and in Young and Masters Athletes

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by BSP Biological Signal Processing Ltd.:

Primary Outcome Measures:
  • Normal values for depolarization characteristics will be established for study groups [ Time Frame: end of data collection ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: February 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample referred or self referred to stress testing

Criteria

Inclusion Criteria:

  • An asymptomatic, apparently healthy patient performing a maximal exercise stress test

Exclusion Criteria:

  • Contraindications for an exercise test
  • Wolff-Parkinson-White (pre-excitation) syndrome
  • Atrial Fibrillation or significant ventricular arrhythmia
  • Treatment with Digoxin
  • Pacemaker
  • Pregnancy or suspected pregnancy
  • QRS duration>120ms or other conduction delays
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847353

Contacts
Contact: • Irena Imanuel, MD 09-8639420
Contact: Eyal Shargal, PhD 09-8639420 Eyal@wingate.org

Locations
Israel
The Ribstein Center for Sports Medicine and Research Recruiting
Netanya, Israel
Contact: Eyal Shargal, PhD         eyal@wingate.org    
Principal Investigator: Dr Irena Imanuel, MD            
Sub-Investigator: Rutie Pilz-Burstein, PhD            
Sponsors and Collaborators
BSP Biological Signal Processing Ltd.
  More Information

No publications provided

Responsible Party: Prinicipal Investigator, The Ribstein Center for Sports Medicine and Research, Wingate
ClinicalTrials.gov Identifier: NCT00847353     History of Changes
Other Study ID Numbers: WIN_01
Study First Received: February 18, 2009
Last Updated: February 3, 2010
Health Authority: Israel: Ethics Commission

Keywords provided by BSP Biological Signal Processing Ltd.:
high frequency ECG
normal values
asymptomatic
obese

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 26, 2012