Ventricular Ejection FractionPhase 4NCT00401687
DMP115 in Patients With an Ejection Fraction Between 25%-40% to Evaluate the Use of Contrast Echocardiography to Assess Heart Function
A Phase 4 study testing Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension in people with Ventricular Ejection Fraction, run by Lantheus Medical Imaging at 10 sites in United States.
Trial summary
The purpose of this clinical research study is to demonstrate the ability of Definity® enhanced versus unenhanced cardiac ultrasound to improve the accuracy and reproducibility of left ventricular ejection fraction (EF) when compared to magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Ejection Fraction
- What is being tested?
- Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
- Type of treatment
- Injection or infusion
- How many people
- 131 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2006to Apr 2008
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects 18 years of age or older
- Have a documented EF value ranging from 25% to 40%
- Have been scheduled to undergo or have undergone a cardiac MRI study
Who cannot join
- Severe valvular dysfunction
- Inability to remain supine for 30 minutes
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Chicago Medical Center
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
University of Texas Medical Branch
Galveston, Texas, 77555
Saint Lukes Mid America Heart Institute
Kansas City, Missouri, 64111
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University
Portland, Oregon, 97239
University of Arizona
Tucson, Arizona, 85727
Washington Hospital Center
Washington DC, Maryland, 20010
About this study
Official title: A Multicenter, Phase IV Study to Evaluate the Ability of Definity® Enhanced Versus Unenhanced Echocardiography to Improve the Accuracy and Reproducibility of Left Ventricular Ejection Fraction When Compared to Cardiac Magnetic Resonance Imaging
The purpose of this clinical research study is to demonstrate the ability of Definity® enhanced versus unenhanced cardiac ultrasound to improve the accuracy and reproducibility of left ventricular ejection fraction (EF) when compared to magnetic resonance imaging (MRI).
- Conditions
- Ventricular Ejection Fraction
- Being tested
- Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
- Keywords
- Reduced Heart Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definity® Vial for (Perflutren Lipid Microsphere) Injectable SuspensionDrug
The intervention for this study was that all patients received a slow bolus injection of diluted DEFINITY during the contrast-enhanced imaging study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the ability of Definity® enhanced versus unenhanced echocardiography to improve the accuracy of left ventricular ejection fraction when compared to cardiac magnetic resonance imaging (MRI) in a blinded assessment
Measured: Following the completion of patient enrollment when the images (ultrasound and MR) were evaluated independently by three blinded readers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Ejection FractionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Veronica Lee, MD, Study director, Lantheus Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401687
- Sponsor's protocol ID
- DMP 115-412
- Status last verified
- May 2011
- First submitted
- 16 Nov 2006
- Last updated
- 20 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase IV Study to Evaluate the Ability of Definity® Enhanced Versus Unenhanced Echocardiography to Improve the Accuracy and Reproducibility of Left Ventricular Ejection Fraction When Compared to Cardiac Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00401687
- Acronym / sponsor ID
- DMP 115-412
- Conditions
- Ventricular Ejection Fraction
- Keywords
- Reduced Heart Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Lantheus Medical ImagingIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Nov 2006 (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.
The purpose of this clinical research study is to demonstrate the ability of Definity® enhanced versus unenhanced cardiac ultrasound to improve the accuracy and reproducibility of left ventricular ejection fraction (EF) when compared to magnetic resonance imaging (MRI).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult subjects 18 years of age or older
- Have a documented EF value ranging from 25% to 40%
- Have been scheduled to undergo or have undergone a cardiac MRI study
Key exclusion criteria (2 listed)
- Severe valvular dysfunction
- Inability to remain supine for 30 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Definity® Vial for (Perflutren Lipid Microsphere) Injectable SuspensionThe intervention for this study was that all patients received a slow bolus injection of diluted DEFINITY during the contrast-enhanced imaging study. | Drug | – |
Primary outcome
Demonstrate the ability of Definity® enhanced versus unenhanced echocardiography to improve the accuracy of left ventricular ejection fraction when compared to cardiac magnetic resonance imaging (MRI) in a blinded assessment
Time frame: Following the completion of patient enrollment when the images (ultrasound and MR) were evaluated independently by three blinded readers.
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 20 May 2011.
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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.
Veronica Lee, MD study director
Lantheus Medical Imaging
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension in people with Ventricular Ejection Fraction, run by Lantheus Medical Imaging at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Demonstrate the ability of Definity® enhanced versus unenhanced echocardiography to improve the accuracy of left ventricular ejection fraction when compared to cardiac magnetic resonance imaging (MRI) in a blinded assessment (time frame: Following the completion of patient enrollment when the images (ultrasound and MR) were evaluated independently by three blinded readers.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2011.