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

February 3, 2010 updated by: BSP Biological Signal Processing Ltd.

Normal Values of High Frequency ECG (HyperQ™) in Asymptomatic, Apparently Healthy Normal Weight vs. Obese Individuals and in Young and Masters Athletes

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: • Irena Imanuel, MD
  • Phone Number: 09-8639420

Study Contact Backup

Study Locations

  • Israel
      • Netanya, Israel
        • Recruiting
        • The Ribstein Center for Sports Medicine and Research
        • Contact:
        • Principal Investigator:
          • Dr Irena Imanuel, MD
        • Sub-Investigator:
          • Rutie Pilz-Burstein, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community sample referred or self referred to stress testing

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Normal values for depolarization characteristics will be established for study groups
Time Frame: end of data collection
end of data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BSP Biological Signal Processing Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

February 18, 2009

First Submitted That Met QC Criteria

February 18, 2009

First Posted (Estimate)

February 19, 2009

Study Record Updates

Last Update Posted (Estimate)

February 4, 2010

Last Update Submitted That Met QC Criteria

February 3, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WIN_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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