Cardiac Elastography to Determine Strain and Strain Rates in the Heart

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT00205387

First received: September 12, 2005

Last updated: August 28, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

August 28, 2012

Start Date ^ICMJE

November 2005

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00205387 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cardiac Elastography to Determine Strain and Strain Rates in the Heart

Official Title ^ICMJE

Cardiac Elastography

Brief Summary

Cardiac elastography is a new technique to analyze strain and strain rates in many organ systems, including the heart. In this study, cardiac elastography derived from the analysis of raw radiofrequency data obtained from a conventional clinical echocardiograph system will be compared to processed information that comes from the same echocardiograph system. The purpose of this study is to determine if cardiac elastography can accurately determine strain and strain rates as compared to more conventional means.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

healthy volunteers and patients with known heart disease caused by myocardial inarction or cardiomyopathy

Condition ^ICMJE

Heart Disease

Intervention ^ICMJE

Procedure: cardiac elastography and echocardiography

standard echocardiogram

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

December 2011

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy normal volunteers between the ages of 18-70
Patients scheduled for clinical echocardiogram between the ages of 18-70 who have known heart disease caused by myocardial infarction or cardiomyopathy

Exclusion Criteria:

Patients less than 18 years old, or greater than 70 years old
Patients who do not have adequate quality echocardiographic images.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00205387

Other Study ID Numbers ^ICMJE

M-2004-1260

Has Data Monitoring Committee

Responsible Party

University of Wisconsin, Madison

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Peter S Rahko, MD

University of Wisconsin, Madison

Information Provided By

University of Wisconsin, Madison

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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