DEF-314 Better Accuracy in EF Assessment With DEFINITY



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:October 24, 2018
End Date:September 2019
Contact:Sandra Monte
Email:sandra.monte@lantheus.com
Phone:: +1 978-671-8118

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A Phase III, Open-Label, Multicenter Trial to Evaluate Ejection Fraction, End-Diastolic and End-Systolic Volumes, by Unenhanced and DEFINITY®-Enhanced 2D-Echo and Magnetic Resonance Imaging

This is a Phase 3, prospective, open-label, multicenter study to evaluate 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.


Inclusion Criteria:

1. Men and women ≥ 18 years of age in sinus rhythm

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:

1. 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.

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) -
We found this trial at
6
sites
New York, New York 10065
Phone: 203-918-6935
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Durham, North Carolina 27710
(919) 684-8111
Phone: 919-668-0927
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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1 Medical Center Drive
Morgantown, West Virginia 26506
Phone: 855-988-2273
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-7765
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, PA
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San Diego, California 92093
Phone: 760-697-3110
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San Diego, CA
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Wilmington, Delaware 19803
Phone: 302-731-0001
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Wilmington, DE
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