Actively Recruiting
Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt in a Randomized Crossover Phase 3 Trial
Led by Agitated Solutions, Inc. · Updated on 2026-06-05
300
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Agitated Solutions, Inc.
Lead Sponsor
B
Bright Research Partners
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial focuses on adults suspected of having a right-to-left shunt and aims to evaluate the safety of a new product called ASI-02 compared to the current standard of care, agitated saline. The study is a phase 3, multicenter, randomized crossover trial conducted at up to eight sites in the U.S. and Canada. The goal is to assess how well ASI-02 detects right-to-left shunts during saline contrast transthoracic echocardiogram (TTE) studies, and to compare its results with those of agitated saline. Participants will undergo two study procedures in random order during a single-day imaging session. Each participant will receive two injections of ASI-02 and four injections of agitated saline as part of the saline contrast echocardiography studies. The ASI-02 product is administered as a 9 mL saline and 1 mL air intravenous bolus, while the agitated saline standard of care involves approximately 10 mL saline mixed with 1 mL air. The study uses a crossover design where participants receive both treatments in a randomized sequence. During the study, participants will be monitored through the procedure and followed up for 24 to 48 hours. Researchers will measure the agreement between ASI-02 and agitated saline in detecting right-to-left shunts, including positive and negative percentage agreements. They will also assess safety by tracking any adverse events related to ASI-02, evaluate contrast opacification intensity and duration, and test reliability. The total duration of participation is about one to two days, including procedure and follow-up.
CONDITIONS
Brief Title
Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is clinically indicated for a saline contrast transthoracic echocardiogram (TTE) study with suspected right-to-left shunt
- Patient is at least 18 years old at the time of informed consent
- Able to communicate effectively with trial personnel
You will not qualify if you...
- Pregnant or lactating female patients
- Women of child-bearing potential must have a negative pregnancy test and use approved contraception for at least 1 month before dosing
- Allergy to polysorbate 80 (PS-80)
- American Society of Anesthesiologists physical status IV, V, or VI, except for certain recent stroke or transient ischemic attack cases
- Current illness or condition posing significant safety risk for investigational product administration
- Uncontrolled high blood pressure (systolic 63 200 mmHg or diastolic 63 110 mmHg) or low blood pressure (systolic 64 90 mmHg)
- Unstable cardiovascular status including recent heart attack, unstable angina, symptomatic or severe valvular heart disease, significant congenital heart defects (except ASD, PFO, or PAVM), uncontrolled arrhythmias, acute pulmonary embolus, myocarditis, pericarditis, aortic dissection, or untreated atrial fibrillation
- Major surgery within 30 days prior to screening
- Participation in another investigational drug, device, or placebo study within 30 days prior to screening
- Vulnerable adult populations such as incarcerated or cognitively challenged adults
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Less than 1 day
Participants undergo saline contrast transthoracic echocardiography studies using both ASI-02 and agitated saline in a randomized crossover design during a single-day imaging session.
1 imaging session with multiple injections
Duration - 24 to 48 hours
Participants are monitored for safety and efficacy outcomes following the imaging session.
1 follow-up visit (in-person or remote)
Trial Site Locations
Total: 6 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
CentraCare
Saint Cloud, Minnesota, United States, 56303
Actively Recruiting
4
Jackson Heart Clinic
Jackson, Mississippi, United States, 39216
Actively Recruiting
5
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
6
Toronto General
Toronto, Canada, M5G 2C4
Actively Recruiting
Research Team
P
Pamela Wolfe
R
Rebecca Zickert
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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