Ultrasound Contrast Agents for Heart Imaging

Recruiting in Kansas City (>99 mi)

+2 other locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Microvascular Therapeutics, LLC

Disqualifiers: Myocardial infarction, Unstable angina, Arrhythmia, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

16 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the drug Definity for heart imaging?

Definity, an ultrasound contrast agent, is effective in improving the clarity of heart images, especially in patients with suboptimal echocardiograms, by enhancing the visibility of the heart's left ventricle. Studies show that using Definity during echocardiography is associated with a 24% decreased risk of mortality within one day compared to not using a contrast agent, indicating its safety and potential benefits in heart imaging. ^{1 2 3 4 5}

Is the ultrasound contrast agent Definity safe for use in heart imaging?

Definity, an ultrasound contrast agent, has been associated with some serious heart and lung reactions, including a few deaths, leading to FDA warnings and monitoring requirements. However, studies show that severe adverse reactions are uncommon, and using Definity does not significantly increase the risk of severe events during stress echocardiography. ^{1 2 5 6 7}

How is the drug Definity unique for heart imaging?

Definity is unique because it is an ultrasound contrast agent specifically designed to improve the clarity of heart images in patients with suboptimal echocardiograms. It uses microbubbles to enhance the visibility of the heart's left ventricular chamber, making it easier to assess heart function and detect abnormalities. ^{1 2 4 5 8}

What is the purpose of this trial?

This trial tests MVT-100, a new ultrasound contrast agent, in healthy volunteers. It aims to see if MVT-100 is safe and effective for improving heart images by using tiny bubbles that reflect ultrasound waves. The study compares MVT-100 to an existing product.

Eligibility Criteria

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.

Inclusion Criteria

I am 19 years old or older.

I am a woman who cannot become pregnant or I am using effective birth control.

Subject must be willing and able to understand the study and provide written Informed Consent to participate in the study

Exclusion Criteria

I have severe lung problems that aren't well-controlled by medication or need oxygen often.

You are allergic to perflutren or other echo contrast agents.

I do not have severe heart problems like unstable chest pain or heart failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either MVT-100 or Definity and undergo echocardiograms after administration via bolus or IV infusion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Definity
• MVT-100

Trial Overview 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.

Participant Groups

Group I: MVT-100 Experimental Treatment 2 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: Definity Active Control 2 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.

Who Is Running the Clinical Trial?

Microvascular Therapeutics, LLC

Lead Sponsor

Trials

2

Recruited

20+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of Nebraska

Collaborator

Trials

563

Recruited

1,147,000+

Findings from Research

In a study involving 1,060 patients, Definity (perflutren lipid microsphere) was found to be well tolerated, with no deaths or serious adverse events reported during or within 30 minutes after administration.

The overall adverse event rate was 10.8%, with a low drug-related adverse event rate of 3.5%, indicating that most adverse events were mild or moderate, making Definity a safe option for patients with suboptimal echocardiograms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CaRES (Contrast Echocardiography Registry for Safety Surveillance): a prospective multicenter study to evaluate the safety of the ultrasound contrast agent definity in clinical practice. Weiss, RJ., Ahmad, M., Villanueva, F., et al.[2022]

In the first year of using the second-generation contrast agent Definity in echocardiography, 161 patients showed a significant improvement in endocardial definition scores (p=0.0001), enhancing the clarity of heart imaging.

The use of contrast echocardiography led to the detection of clinically significant conditions that were missed in standard 2D imaging, with a very low adverse event rate of only 0.6%, indicating its safety and efficacy in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast echocardiography in Australian clinical practice. Hamilton-Craig, C., Boga, T., West, C., et al.[2022]

Echocardiography, while commonly used to assess heart function, can be suboptimal in 15-20% of cases, but using ultrasound microbubble contrast like DEFINITY® significantly improves diagnostic accuracy and helps salvage nondiagnostic studies.

DEFINITY® is an FDA-approved microbubble contrast agent that enhances left ventricular imaging, providing clearer assessments of cardiac function and wall motion abnormalities, with a well-defined safety profile and clinical indications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of ultrasound contrast agents in current clinical practice with special focus on DEFINITY® in cardiac imaging. Salih, M., Ali, SM., Jena, N., et al.[2022]

A 73-year-old patient experienced sudden death shortly after receiving a perflutren contrast agent during an echocardiogram, highlighting potential risks associated with its use in patients with severe heart conditions.

Despite the timing of the death, autopsy results did not establish a direct link between the perflutren agent and the fatal event, suggesting that this case may represent a pseudocomplication rather than a direct adverse effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudden death after intravenous administration of a perflutren contrast agent: a case of pseudocomplication? Mahjoub, H., Roméo, P., Leung, TK., et al.[2014]

In response to serious safety concerns, including 4 patient deaths and 190 serious reactions, the FDA issued a 'black box' warning for ultrasound contrast agents Definity and Optison, leading to a significant decline in their use in the US.

Recent safety data and discussions from the FDA Cardio-Renal panel indicate ongoing evaluation of these agents, with revised labeling aimed at improving safety protocols for contrast echocardiography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound contrast agents: balancing safety versus efficacy. Main, ML., Goldman, JH., Grayburn, PA.[2022]

In a study involving 4,786 patients undergoing stress echocardiography, the use of perflutren-based contrast agents like Definity and Optison did not increase the risk of severe adverse events compared to patients who did not receive contrast.

The rates of serious complications, including death within 24 hours and cardiac arrest, were similar between those receiving contrast and those who did not, indicating that the use of these contrast agents is generally safe in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents in stress echocardiography. Gabriel, RS., Smyth, YM., Menon, V., et al.[2015]

In two patients with cardiac tamponade, echocardiographic-guided pericardiocentesis successfully drained bloody fluid, demonstrating the procedure's efficacy in managing this condition.

The use of Definity perflutren lipid microspheres as echocardiographic contrast during the procedure is a novel approach that enhanced the accuracy of needle placement, marking the first reported application of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perflutren microspheres for contrast echocardiography in a bloody pericardiocentesis. Escabí-Mendoza, JE., Martínez-Díaz, JD., Avilés-Rivera, ED.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

CaRES (Contrast Echocardiography Registry for Safety Surveillance): a prospective multicenter study to evaluate the safety of the ultrasound contrast agent definity in clinical practice. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Contrast echocardiography in Australian clinical practice. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Acute mortality in hospitalized patients undergoing echocardiography with and without an ultrasound contrast agent (multicenter registry results in 4,300,966 consecutive patients). [2022]

4. England pubmed.ncbi.nlm.nih.gov

Review of ultrasound contrast agents in current clinical practice with special focus on DEFINITY® in cardiac imaging. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Sudden death after intravenous administration of a perflutren contrast agent: a case of pseudocomplication? [2014]

6. England pubmed.ncbi.nlm.nih.gov

Ultrasound contrast agents: balancing safety versus efficacy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents in stress echocardiography. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Perflutren microspheres for contrast echocardiography in a bloody pericardiocentesis. [2018]