Intracardiac Echocardiography for Hypertrophic Cardiomyopathy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

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

Compensation: Varies

Number of Visits: 1

Duration: Less than 1 week

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a follow up investigation to our previous study entitled "On-pump intraoperative echocardiography (OPIE)" (clinicaltrials.gov NCT03094325) whereby we determined that left ventricular septal thickness as measured by the OPIE technique correlates highly with traditional methods of transthoracic and transesophageal echocardiography during septal myectomy for hypertrophic cardiomyopathy. OPIE may be especially useful in patients with a thin ventricular septal thickness as adequate treatment may rely on mere millimeters of myocardial resection. We therefore propose a study in which OPIE is compared to transthoracic and transesophageal echocardiography in patients with a thin interventricular septum. Subjects will receive the same perioperative care regardless of their involvement in the study. Patients who enroll in the study will undergo an additional intraoperative echocardiographic measurement that adds less than five minutes to total operative time.

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 might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment On-pump Intracardiac Echocardiography for Hypertrophic Cardiomyopathy?

Echocardiography, including intracardiac echocardiography, is crucial in diagnosing and managing hypertrophic cardiomyopathy by providing detailed images of the heart's structure and function. It helps guide treatment decisions, assess the effectiveness of therapies, and plan surgical procedures, making it a valuable tool in managing this condition. ^{1 2 3 4 5}

Is intracardiac echocardiography safe for humans?

The research articles provided do not specifically address the safety of intracardiac echocardiography for hypertrophic cardiomyopathy, but they do discuss the safety of related echocardiography techniques. These studies generally indicate that echocardiography, including stress echocardiography, is considered safe, though there are rare but potentially serious adverse reactions. ^{6 7 8 9 10}

How does intracardiac echocardiography differ from other treatments for hypertrophic cardiomyopathy?

Intracardiac echocardiography is unique because it provides real-time images from inside the heart, allowing doctors to see the heart's structure and blood flow directly during procedures. This can help guide treatments more precisely compared to traditional external echocardiography, which views the heart from outside the body. ^{2 3 11 12 13}

Research Team

Daniel Swistel, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults over 18 with hypertrophic cardiomyopathy scheduled for septal myectomy and have a thin interventricular septum (less than 2.0 cm wide) as shown by echocardiography. It's open to all genders and races.

Inclusion Criteria

I am over 18, have hypertrophic cardiomyopathy, and will have surgery to remove part of my heart muscle.

Exclusion Criteria

I am under 18 and scheduled for heart surgery due to thickened heart muscle.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo intraoperative echocardiographic measurement using the OPIE technique during septal myectomy

Less than 1 week

1 visit (in-person, intraoperative)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 to 12 months

Treatment Details

Interventions

• On-pump Intracardiac Echocardiography

Trial Overview The study tests on-pump intracardiac echocardiography (OPIE) against traditional transthoracic and transesophageal methods in measuring ventricular septal thickness during surgery for those with a thin septum.

Participant Groups

Group I: OPIE in thin inverventricular septum Experimental Treatment 1 Intervention

The Principal Investigator use the OPIE probe to measure the anterior basilar septal thickness. Myectomy will be performed and OPIE will be repeated.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Echocardiography in the treatment of hypertrophic cardiomyopathy. [2016]

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

Echocardiographic and Doppler assessment of hypertrophic cardiomyopathy. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Echocardiographic and Doppler studies in hypertrophic cardiomyopathy. [2005]

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

The role of echocardiography in hypertrophic cardiomyopathy. [2018]

5. Brazil pubmed.ncbi.nlm.nih.gov

Intraoperative transesophageal echocardiography in septal hypertrophic cardiomyopathy. [2019]

6. Australia pubmed.ncbi.nlm.nih.gov

The safety profile of perflutren microsphere contrast echocardiography during rest and stress imaging: results from an Australian multicentre cohort. [2014]

7. England pubmed.ncbi.nlm.nih.gov

Safety of dobutamine stress echocardiography in 474 consecutive studies. [2019]

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

Prognostic significance of exercise induced arrhythmias and echocardiographic variables in hypertrophic cardiomyopathy. [2019]

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

Evolution of dobutamine echocardiography protocols and indications: safety and side effects in 3,011 studies over 5 years. [2019]

10. Poland pubmed.ncbi.nlm.nih.gov

[Safety of stress echocardiography with dobutamine used in patients with aortic stenosis and left ventricular dysfunction]. [2016]

11. Italy pubmed.ncbi.nlm.nih.gov

Noninvasive assessment of intramyocardial coronary flow in hypertrophic cardiomyopathy by high-resolution Doppler echocardiography. [2016]

12. Hungary pubmed.ncbi.nlm.nih.gov

[The role of real-time three-dimensional echocardiography in the evaluation of hypertrophic cardiomyopathy]. [2016]

13. Netherlands pubmed.ncbi.nlm.nih.gov

New directions in intracardiac echocardiography. [2018]