NCT00001740

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1997

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2000

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

November 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Heart Diseases

Keywords

CardiacFunctionMRIReconstructionUltrasoundHeart Disease (Cardiovascular Disease)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • 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.

    PMID: 7572591BACKGROUND

  • 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.

    PMID: 8260164BACKGROUND

MeSH Terms

Conditions

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

October 1, 1997

Study Completion

October 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-11

Locations

US(1)