DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY
NCT ID: NCT03571672
Last Updated: 2020-12-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
153 participants
INTERVENTIONAL
2018-10-24
2019-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DEFINITY
Each patient will undergo an unenhanced ultrasound examination and a DEFINITY contrast-enhanced ultrasound
DEFINITY
All subjects will receive a single dose of DEFINITY®
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DEFINITY
All subjects will receive a single dose of DEFINITY®
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Able to communicate effectively with trial personnel
3. Has undergone a 2D Echo with or without contrast obtained within 6 months prior to enrollment (Day 0)
4. Has provided signed informed consent after receiving a verbal and written explanation of this clinical trial -
Exclusion Criteria
2. Women of child-bearing potential are excluded unless they:
1. are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR
2. have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR
3. have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to DEFINITY® dose administration and be willing to continue using the same method for the duration of the study.
3. Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
4. Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg).
5. Unstable cardiovascular status defined as:
1. myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day
2. transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration
3. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
4. clinically significant congenital heart defects
5. current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
6. acute pulmonary embolus or pulmonary infarction
7. acute myocarditis or pericarditis
8. acute aortic dissection
9. atrial fibrillation
6. any major surgery within 4 weeks prior to screening
7. known contraindications to undergoing CMR or claustrophobia
8. participation in any investigational drug, device, or placebo study within 30 days prior to screening
9. known hypersensitivity to perflutren, or any of the excipients in DEFINITY®
10. prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (e.g., infectious disease) -
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Syneos Health
OTHER
Lantheus Medical Imaging
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Banner University of Arizona Medical Center
Tucson, Arizona, United States
University of California-San Diego
San Diego, California, United States
Alfieri Cardiology
Wilmington, Delaware, United States
Henry Ford Hospital
Detroit, Michigan, United States
Weill Cornell Medical Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
University Hospital/Cleveland Medical Center
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
West Virginia University Medical Center
Morgantown, West Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DEF-314
Identifier Type: -
Identifier Source: org_study_id