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Purpose

This is a phase 3, multicenter, open-label, blinded, crossover trial in which each participant will undergo a randomized sequence of ASI-02 and agitated saline standard of care (SoC) via a saline contrast transthoracic echocardiogram (TTE) study.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Patient is clinically indicated for a saline contrast TTE study with a suspected right-to-left shunt 2. Patient must be at least 18 years of age inclusive, at the time of signing the informed consent 3. Able to communicate effectively with trial personnel

Exclusion Criteria

  1. Female patients 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. WOCBP are excluded unless they have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to ASI-02 dose administration 3. Allergy to polysorbate 80 (PS-80) 4. American Society of Anesthesiologists (ASA) physical status classification IV, V, or VI, except that participants with ASA physical status IV due solely to recent suspected transient ischemic attack or cerebrovascular accident are eligible for inclusion 5. Current illness or pathology that in the opinion of the investigator would prevent undergoing investigational product administration due to a significant safety risk to the patient 6. 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) 7. Unstable cardiovascular status defined as: 1. myocardial infarction or unstable angina pectoris within 6 months prior to procedure day 2. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease 3. clinically significant congenital heart defects (excluding an atrial septal defect [ASD], patent foramen ovale [PFO], or pulmonary arteriovenous malformation [PAVM]) 4. current uncontrolled cardiac arrhythmias causing clinical symptoms requiring medical intervention or hemodynamic compromise 5. acute pulmonary embolus or pulmonary infarction 6. acute myocarditis or pericarditis 7. acute aortic dissection 8. untreated atrial fibrillation 8. Any major surgery within 30 days prior to screening 9. Participation in any investigational drug, device, or placebo study within 30 days prior to screening 10. Vulnerable adult participant populations (e.g., incarcerated or cognitively challenged adults)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
For each participant, the first two (2) injections will be agitated saline SoC (one [1] injection at rest, one [1] injection during a maneuver). Next, participants will be randomized to either receive two (2) ASI-02 injections followed by two (2) agitated saline SoC injections, or vice versa (with each pair involving an injection at rest and an injection during a maneuver).
Primary Purpose
Diagnostic
Masking
Single (Outcomes Assessor)
Masking Description
This is an open-label study; therefore, blinding procedures are not necessary for site personnel or participants. Blinded assessment of the primary efficacy endpoint will be completed by the core lab.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Standard of Care to ASI-02 TTE Study 		Participants will be allocated to a saline contrast echocardiography study with agitated saline SoC, followed by a saline contrast echocardiography study with ASI-02.
  • Drug: Agitated Saline SoC
    The recommended initial dose of agitated saline SoC is approximately 10 mL of saline containing approximately 1 mL of air, per institutional policy, rapidly mixed (approximately 10-20 presses) to manufacture microbubbles. No additives are allowed to the saline, including blood, dextrose, or bacteriostatic saline.
  • Drug: ASI-02
    Each injection shall utilize one (1) ASI-02 product connected to one (1) pre-filled 10 mL 0.9% sodium chloride (saline) syringe. The ASI-02 investigational product will be connected to a standard luer lock connector and administered in its entirety. The intravenous bolus injected dose of ASI-02 is 9 mL of saline and 1 mL of air.
Experimental
ASI-02 to Standard of Care TTE Study 		Participants will be allocated to a saline contrast echocardiography study with ASI-02, followed by a saline contrast echocardiography study with agitated saline SoC.
  • Drug: Agitated Saline SoC
    The recommended initial dose of agitated saline SoC is approximately 10 mL of saline containing approximately 1 mL of air, per institutional policy, rapidly mixed (approximately 10-20 presses) to manufacture microbubbles. No additives are allowed to the saline, including blood, dextrose, or bacteriostatic saline.
  • Drug: ASI-02
    Each injection shall utilize one (1) ASI-02 product connected to one (1) pre-filled 10 mL 0.9% sodium chloride (saline) syringe. The ASI-02 investigational product will be connected to a standard luer lock connector and administered in its entirety. The intravenous bolus injected dose of ASI-02 is 9 mL of saline and 1 mL of air.

Recruiting Locations

Northwestern University
Chicago 4887398, Illinois 4896861 60611

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905

Jackson Heart Clinic
Jackson 4431410, Mississippi 4436296 39216

NYU Langone Health
New York 5128581, New York 5128638 10016

More Details

Status
Recruiting
Sponsor
Agitated Solutions, Inc.

Study Contact

Pamela Wolfe
763-258-7027
pamela@agitatedsolutions.com

Detailed Description

The primary objective is to determine the safety of ASI-02 and its agreement with agitated saline SoC for detection of right-to-left shunt in saline contrast studies utilizing TTE in the intended setting of use (opacifying the right heart). The investigation will be conducted in up to 8 investigational sites in the U.S. and Canada. Participants will receive n=2 ASI-02, n=4 agitated saline SoC injections as part of a single-day imaging session, with the overall duration for study participation of 24 to 48 hours.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.