Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion

Description

Summary

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.

Official Title

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

Keywords

Cardiac DiseaseLeft Ventricular Ejection FractionDEFINITYEnhanced EchocardiogramCardiac Magnetic ResonanceHeart Diseases

Eligibility

You can join if…

Open to people ages 18 years and up

  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 -

You CAN'T join if...

  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:
  3. are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR
  4. have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR
  5. 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.
  6. Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
  7. 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).
  8. Unstable cardiovascular status defined as:
  9. myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day
  10. transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration
  11. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
  12. clinically significant congenital heart defects
  13. current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
  14. acute pulmonary embolus or pulmonary infarction
  15. acute myocarditis or pericarditis
  16. acute aortic dissection
  17. atrial fibrillation
  18. any major surgery within 4 weeks prior to screening
  19. known contraindications to undergoing CMR or claustrophobia
  20. participation in any investigational drug, device, or placebo study within 30 days prior to screening
  21. known hypersensitivity to perflutren, or any of the excipients in DEFINITY®
  22. . 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) -

Locations

  • University of California-San Diegoaccepting new patients
    San DiegoCalifornia92037United States
  • West Virginia University Medical Centeraccepting new patients
    MorgantownWest Virginia26505United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Lantheus Medical Imaging
ID
NCT03571672
Phase
Phase 3
Study Type
Interventional
Last Updated