Evaluation of Left Ventricular Volumes by Real-Time 3-Dim... | NCT00001740

Studies
Evaluation of Left Ventricular Volumes by Real-Time 3-Dimensional Echocardiography

NCT00001740

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Status

Completed

Last Update Posted

Mar 4, 2008Estimated

Enrollment

240

Phase

Not provided

Conditions

Heart Diseases

Interventions

Not provided

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

ID	Type	Description	Link
98-H-0016

Status Module

Record Verification Date

Nov 1999

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

Oct 1997

Primary Completion Date

Not provided

Completion Date

Oct 2000

First Submitted Date

Nov 3, 1999

First Submission Date that Met QC Criteria

Dec 9, 2002

First Posted Date

Dec 10, 2002Estimated

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

Mar 3, 2008

Last Update Posted Date

Mar 4, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Heart, Lung, and Blood Institute (NHLBI)NIH

Collaborators

Not provided

Description Module

Brief Summary

Quantitative measurements of left ventricular volume and ejection fraction are useful in the management of patients with heart disease. Several imaging methods exist, but are limited by cost, invasiveness, or exposure to radio-isotopes. Conventional echocardiography is a noninvasive method that allows estimation of left ventricular size and function; however, quantitative measurements of volume are not widely used due to lack of reproducibility and inaccurate measurements. Real-time three-dimensional echocardiography is a new technique that can be used to derive volume measurements from a single image acquisition. We hypothesize that real-time three-dimensional echocardiography is an accurate method for making left ventricular volume measurements. We therefore propose to measure left ventricular volumes using real-time three-dimensional echocardiography in human subjects and correlate these measurements with magnetic resonance imaging, a more accurate noninvasive method for obtaining these measurements.

Detailed Description

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

240

Eligibility Module

Eligibility Criteria

Normal volunteers and patients with any form of heart disease who agree to undergo MRI and echocardiographic examination studies.

Adults older than the age of 18 years.

No pregnancy, atrial fibrillation, unstable angina, recent myocardial infarction (less than 5 days), or other acute medical illness.

No pacemaker, aneurysm clip, neural stimulator, ear implant, and metallic foreign body such as shrapnel or bullets.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Heart, Lung and Blood Institute (NHLBI)		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7572591	Background	Siu SC, Levine RA, Rivera JM, Xie SW, Lethor JP, Handschumacher MD, Weyman AE, Picard MH. Three-dimensional echocardiography improves noninvasive assessment of left ventricular volume and performance. Am Heart J. 1995 Oct;130(4):812-22. doi: 10.1016/0002-8703(95)90082-9.
8260164	Background	Schroder KM, Sapin PM, King DL, Smith MD, DeMaria AN. Three-dimensional echocardiographic volume computation: in vitro comparison to standard two-dimensional echocardiography. J Am Soc Echocardiogr. 1993 Sep-Oct;6(5):467-75. doi: 10.1016/s0894-7317(14)80465-3.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases