Cardiac Elastography to Determine Strain and Strain Rates... | NCT00205387

Studies
Cardiac Elastography to Determine Strain and Strain Rates in the Heart

NCT00205387

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Aug 29, 2012Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Heart Disease

Interventions

cardiac elastography and echocardiography

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 19, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2012

Last Update Posted Date

Aug 29, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiac elastography and echocardiography	Procedure	standard echocardiogram

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter S Rahko, MD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin		Madison	Wisconsin	53792	United States