DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY

Completed · Phase 3

Conditions studied: Cardiac Disease

In brief

This is a Phase 3, prospective, open-label, multicenter study to evaluate Left Ventricular Ejection Fraction (LVEF) measurement accuracy and reproducibility of DEFINITY® contrast-enhanced and unenhanced echocardiography as compared with non-contrast cardiac magnetic resonance imaging (CMR) used as the truth standard.

Key facts

Study ID

NCT03571672

Run by

Lantheus Medical Imaging

People needed

153

Starts

2018-10-24

Expected to finish

2019-08-30

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ≥ 18 years of age in sinus rhythm
• Able to communicate effectively with trial personnel
• Has undergone a 2D Echo with or without contrast obtained within 6 months prior to enrollment (Day 0)
• Has provided signed informed consent after receiving a verbal and written explanation of this clinical trial -

You may not qualify if…

• Female subjects who are pregnant or lactating. All women of child bearing potential [WOCBP] must have a negative urine pregnancy test at screening regardless of contraceptive use history.
• Women of child-bearing potential are excluded unless they:
• are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR
• have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR
• 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.
• Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
• 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).
• Unstable cardiovascular status defined as:
• myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day
• transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration
• symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
• clinically significant congenital heart defects
• current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
• acute pulmonary embolus or pulmonary infarction
• acute myocarditis or pericarditis
• acute aortic dissection
• atrial fibrillation
• any major surgery within 4 weeks prior to screening
• known contraindications to undergoing CMR or claustrophobia
• participation in any investigational drug, device, or placebo study within 30 days prior to screening
• known hypersensitivity to perflutren, or any of the excipients in DEFINITY®
• 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) -

Where it is running

• 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

Full record on ClinicalTrials.gov

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