Heart DiseasesNCT00001740
Evaluation of Left Ventricular Volumes by Real-Time 3-Dimensional Echocardiography
An observational study of Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1997to Oct 2000
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
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.
Read the detailed 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.
- Conditions
- Heart Diseases
- Keywords
- Cardiac, Function, MRI, Reconstruction, Ultrasound, Heart Disease (Cardiovascular Disease)
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startOct 1997
- Study completionOct 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 240 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001740
- Sponsor's protocol ID
- 980016
- Other IDs
- 98-H-0016
- Status last verified
- Nov 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 7572591Schroder 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.
PubMed 8260164
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Left Ventricular Volumes by Real-Time 3-Dimensional Echocardiography
- ClinicalTrials.gov ID
- NCT00001740
- Acronym / sponsor ID
- 980016
- Conditions
- Heart Diseases
- Keywords
- Cardiac, Function, MRI, Reconstruction, Ultrasound, Heart Disease (Cardiovascular Disease)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Oct 1997
- Study completion
- Oct 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 7572591Siu 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.
- Background: PubMed 8260164Schroder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001740, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.