Comparing ASI-02 with agitated saline for detecting suspected right-to-left shunts

A Phase 3, Open-label, Multicenter, Randomized Crossover Trial Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt

This will test whether ASI-02 works as safely and reliably as agitated saline for detecting right-to-left heart shunts in adults who need a saline contrast echocardiogram.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Agitated Solutions, Inc. (Industry-sponsored)
• Locations: 5 sites (Chicago, Illinois and 4 other locations)
• Trial ID: NCT06938347 on ClinicalTrials.gov

What this trial studies

This is a phase 3, multicenter, open-label crossover trial in which each adult participant receives both ASI-02 and agitated saline in a randomized sequence during a single-day saline contrast transthoracic echocardiogram session. Participants will receive two ASI-02 and four agitated saline injections while images are recorded to determine agreement between the two contrast methods and to monitor for safety. The trial is being conducted at up to eight sites in the U.S. and Canada and uses blinded image interpretation despite the open-label administration. Overall participation spans about 24 to 48 hours including screening and the imaging visit.

Who should consider this trial

Good fit: Adults (18+) who have a clinical indication for a saline contrast transthoracic echocardiogram to look for a suspected right-to-left shunt, who can communicate with study staff and meet safety criteria, are ideal candidates.

Not a fit: Patients who are pregnant or lactating, allergic to polysorbate 80, not adults, or otherwise excluded by medical criteria (for example certain high ASA physical status classifications) are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, ASI-02 could offer a ready-to-use contrast option that makes saline contrast TTEs more consistent and potentially safer for detecting right-to-left shunts.

How similar studies have performed: Agitated saline is an established standard for saline contrast TTE, while commercially prepared microbubble products like ASI-02 are a newer approach with limited prior large-scale data.

Eligibility criteria

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)

Where this trial is running

Chicago, Illinois and 4 other locations

• Northwestern University — Chicago, Illinois, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• Jackson Heart Clinic — Jackson, Mississippi, United States (Recruiting)
• NYU Langone Health — New York, New York, United States (Recruiting)
• Toronto General — Toronto, Canada (Recruiting)

Study contacts

• Principal investigator: Akhil Narang, MD — Northwestern Medicine
• Study coordinator: Pamela Wolfe

Conditions Right-To-Left Shunt; Saline Contrast; Saline Contrast Transthoracic Echocardiogram; Transthoracic Echocardiogram; Agitated Saline Standard of Care; Echocardiogram; Transpulmonary Shunt