Clinical trial NCT06938347: Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Right-To-Left Shunt
Keywords: Saline Contrast
Saline Contrast Transthoracic Echocardiogram
Transthoracic Echocardiogram
Agitated Saline Standard of Care
Echocardiogram
Transpulmonary Shunt
Lead sponsor: Agitated Solutions, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bright Research Partners
First posted: 2025-04-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

Brief summary: 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.

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.

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)

Primary outcomes:
measure: Positive percentage agreement (PPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC
timeFrame: Procedure through 24- to 48-hour participant follow-up visit
measure: Negative percentage agreement (NPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC
timeFrame: Procedure through 24- to 48-hour participant follow-up visit
Secondary outcomes:
measure: The incidence of ASI-02-related adverse events
timeFrame: 24- to 48-hour participant follow-up visit
measure: Peak opacification intensity
timeFrame: Procedure through 24- to 48-hour participant follow-up visit
measure: Contrast opacification duration
timeFrame: Procedure through 24- to 48-hour participant follow-up visit
measure: Positive percentage agreement (PPA) of ASI-02 for shunt detection at rest
timeFrame: Procedure through 24- to 48-hour participant follow-up visit
measure: Negative percentage agreement (NPA) of ASI-02 for shunt detection at rest
timeFrame: Procedure through 24- to 48-hour participant follow-up visit
measure: Positive percentage agreement (PPA) of ASI-02 for shunt detection specific to shunt sizes
timeFrame: Procedure through 24- to 48-hour participant follow-up visit
measure: Negative percentage agreement (NPA) of ASI-02 for shunt detection specific to shunt sizes
timeFrame: Procedure through 24- to 48-hour participant follow-up visit
measure: Test-retest reliability of agitated saline SoC
timeFrame: Procedure through 24- to 48-hour participant follow-up visit
measure: Positive percentage agreement (PPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC, using the first (nonrandomized) SoC study.
timeFrame: Procedure through 24- to 48-hour participant follow-up visit
measure: Negative percentage agreement (NPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC, using the first (nonrandomized) SoC study.
timeFrame: Procedure through 24- to 48-hour participant follow-up visit
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern Medicine
name: Akhil Narang, MD
role: PRINCIPAL_INVESTIGATOR
References: