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Ultrasound Contrast Agents for Heart Imaging

Phase 1 & 2

Recruiting

Research Sponsored by Microvascular Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate hematologic, renal and hepatic function, as defined by: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, Platelet count ≥ 100 x 10^9/L, Hemoglobin ≥ 90 g/L, Plasma creatinine< 1.5 x ULN, Total bilirubin within normal limits (< 2.5 x ULN if Gilbert's syndrome), Aspartate transaminase (AST) and Alanine transaminase (ALT) < 2.5 x ULN

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of study

Awards & highlights

Study Summary

This trial is evaluating the safety & efficacy of a new ultrasound contrast, MVT-100, in healthy volunteers to improve imaging of the heart's left ventricle. Patients receive either MVT-100 or Definity & have echocardiograms to measure safety & heart border delineation.

Who is the study for?

Healthy adults over 19, who can't have children or will use birth control, with normal blood counts and organ function. Excluded are those with recent heart attacks, unstable angina, severe heart failure, significant arrhythmias in the last six months, allergies to similar drugs or soy/egg products, participation in other trials within 30 days, conditions making lying flat for an hour difficult or certain lung issues.Check my eligibility

What is being tested?

The trial tests MVT-100 against Definity (both ultrasound contrast agents) in healthy volunteers using a single ascending dose method. Participants receive one of the two drugs and then undergo echocardiograms to assess safety and how well they help visualize the heart's inner lining during ultrasound.See study design

What are the potential side effects?

Potential side effects may include allergic reactions due to similarities with other compounds or ingredients like soy/egg products. Specific side effects aren't listed but would likely relate to infusion reactions such as discomfort at injection site or imaging-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My blood, kidney, and liver tests are within normal ranges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood Pressure

Heart Rate

Other Symptoms

+2 more

Secondary outcome measures

Cardiac Segment Visualization

Left Ventricular Opacification (LVO)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MVT-100Experimental Treatment2 Interventions

Each subject receives 100 uL x 2, 200 uL x 3, 300 uL x 2 or 1 vial of MVT-100 diluted in 50 mL of NS as follows: Two milliliter bolus over 10 seconds prior to each infusion rate;, then infusions will run for 5 minutes at 60 mL per hour, 5 minutes at 90 mL per hour, 5 minutes at 100 mL per hour and 5 minutes at 120 mL per hour.

Group II: DefinityActive Control2 Interventions

Each subject receives 100 uL x 2, 200 uL x 3, 300 uL x 2 or 1 vial of DEFINITY® 100 diluted in 50 mL of NS as follows: Two milliliter bolus over 10 seconds prior to each infusion rate;, then infusions will run for 5 minutes at 60 mL per hour, 5 minutes at 90 mL per hour, 5 minutes at 100 mL per hour and 5 minutes at 120 mL per hour.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Echocardiogram

2016

Completed Phase 2

~1870

0 / 1Eligibility criteria met