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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Northwestern University
  Chicago, Illinois, United States Recruiting
• AH Illinois Masonic Center
  Chicago, Illinois, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• CentraCare
  Saint Cloud, Minnesota, United States Recruiting
• Jackson Heart Clinic
  Jackson, Mississippi, United States Recruiting
• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Akhil Narang, MD — Northwestern Medicine
• Study coordinator: Pamela Wolfe
• Email: pamela@agitatedsolutions.com
• Phone: 763-258-7027

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.