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

This study is currently recruiting participants.

Verified by BSP Biological Signal Processing Ltd., February 2009

First Received: February 18, 2009 No Changes Posted

Sponsored by:	BSP Biological Signal Processing Ltd.
Information provided by:	BSP Biological Signal Processing Ltd.
ClinicalTrials.gov Identifier:	NCT00847353

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

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Keywords provided by BSP Biological Signal Processing Ltd.:

high frequency ECG
normal values
asymptomatic
obese

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Healthy

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 07, 2009