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

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001740
• Other study ID #: 980016
• Secondary ID: 98-H-0016
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: October 1997
• Est. completion date: October 2000

Study information

• Verified date: November 1999
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Heart Diseases

Locations

Country	Name	City	State
United States	National Heart, Lung and Blood Institute (NHLBI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Schröder 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. — View Citation

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. — View Citation