DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY

NCT ID: NCT03719612

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-28
• Study Completion Date: 2020-01-09

Brief Summary

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.

Conditions

Cardiac Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

DEFINITY®

Each patient will undergo an unenhanced ultrasound examination and a DEFINITY® contrast-enhanced ultrasound

Group Type: EXPERIMENTAL

DEFINITY®

Intervention Type: DRUG

All subjects will receive a single dose of DEFINITY®

Interventions

DEFINITY®

All subjects will receive a single dose of DEFINITY®

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. Able to communicate effectively with trial personnel

3. LVEF measurements obtained via 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 (e.g. implanted pacemakers, cardioverter, defibrillators) 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

Lantheus Medical Imaging

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Banner University of Arizona Medical Center

Tucson, Arizona, United States

Cedars Sinai

Los Angeles, California, United States

University of California-Irvine

Orange, California, United States

UC San Diego

San Diego, California, United States

Alfieri Cardiology

Wilmington, Delaware, United States

Northwestern Medical Group

Chicago, Illinois, United States

Indiana University

Bloomington, Indiana, United States

Baptist Hospital

Paducah, Kentucky, United States

Mercy Unit Hospital

Coon Rapids, Minnesota, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

Oregon Health and Sciences University

Portland, Oregon, United States

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Baylor Scott White Research Institute

Temple, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DEF-315

Identifier Type: -

Identifier Source: org_study_id