Contrast Enhanced Three Dimensional Echocardiographic Quantification of Right Ventricular Volumes in Repaired Tetralogy of Fallot

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Brief Title

Contrast Enhanced Three Dimensional Echocardiographic Quantification of Right Ventricular Volumes in Repaired Tetralogy of Fallot

Official Title

Contrast Enhanced Three Dimensional Echocardiographic Quantification of Right Ventricular Volumes in Repaired Tetralogy of Fallot

Brief Summary

      We propose the novel integration of two echocardiographic technologies - three-dimensional
      echocardiography using semi-automated right ventricular analysis coupled with the
      administration of ultrasound enhancing agents - to improve the inter-rater reliability and
      accuracy of various measures of right ventricular size and function, compared with cardiac
      MRI.
    

Detailed Description

      Patients with repaired tetralogy of Fallot represent a challenging group of patients with
      congenital heart disease as they develop progressive right ventricular dilation and failure,
      increasing the risk for sudden cardiac death and often necessitating pulmonary valve
      replacement. These patients require close follow-up with serial cardiac imaging; however, the
      complex three-dimensional structure of these dilated right ventricles renders them difficult
      to adequately image with traditional two-dimensional echocardiography. Due to these
      difficulties, cardiac MRI is the current gold standard for assessing right ventricular size
      and function in these patients. However, cardiac MRI is costly and less accessible for
      patients than echocardiography. Although initial studies comparing 3D echocardiography with
      MRI showed that 3D echocardiography underestimates right ventricular size, recent advances in
      three-dimensional imaging technologies which utilize automated ultrasound "speckle-tracking"
      and artificial intelligence technology are lessening this inherent bias. Furthermore, the use
      of commercially-available ultrasound enhancing agents made of lipid microspheres has improved
      left ventricular endocardial border detection, inter-rater reliability and correlation of 3D
      echocardiography obtained estimates of left ventricular size and function compared with CMR.
      However, their use has yet to be applied to the three-dimensional echocardiographic
      assessment of the right ventricle despite their ability to improve right ventricular
      endocardial border detection with two-dimensional echocardiography. The investigators propose
      the novel integration of two echocardiographic technologies - three-dimensional
      echocardiography using semi-automated right ventricular analysis coupled with the
      administration of ultrasound enhancing agents - to change the paradigm of how clinicians
      assess the right ventricles of patients with repaired tetralogy of Fallot. The investigators
      hypothesize that ultrasound enhancing agents will improve the inter-rater reliability and
      accuracy of various measures of right ventricular size and function, compared with cardiac
      MRI, thereby filling an important gap in existing methods for assessing right ventricular
      function. Lastly, because of the current limitations in assessing right ventricular function
      in this population, as a secondary aim, the investigators will also assess three-dimensional
      right ventricular strain -- a novel quantitative surrogate of right ventricular function.

      Overall Objectives: To shift the paradigm in the assessment of right ventricular size and
      function by developing a protocol to assess the right ventricles in patients with repaired
      tetralogy of Fallot by integrating the use of three-dimensional echocardiography with
      semi-automated right ventricular analysis software with the intravenous administration of
      ultrasound enhancing agents.

      Specific Aim 1. To compare the accuracy and inter-rater reliability of 3D
      echocardiography-based measurements of right ventricular end-diastolic volume, end-systolic
      volume, and ejection fraction, with and without contrast, with MRI derived values in patients
      with repaired tetralogy of Fallot.

      Specific Aim 2. To compare the accuracy and inter-rater reliability of 3D echocardiography
      measurement of right ventricular strain with MRI derived RV strain in patients with repaired
      tetralogy of Fallot.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Accuracy of 3D echocardiography based measurements of right ventricular size and function compared to MRI derived values.

Secondary Outcome

 Comparing echocardiographic and MRI derived right ventricular strain measurement.

Condition

Tetralogy of Fallot

Intervention

Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]

Study Arms / Comparison Groups

 diagnostic arm
Description:  The echocardiography team will perform baseline echocardiographic views of the right ventricle without contrast. The patient will receive the weight-based dose of Lumason of 0.03 mL/kg per injection, not to exceed 2.4 mL per injection per the FDA and manufacturer recommendations. Dosages and timing of administration as well as patient size and transducer type will be recorded for each patient. The total cumulative dose of Lumason from the clinical study and the research study will not exceed the maximum recommended dose by the manufacturer, 4.8 mL. A single injection will not exceed the maximal FDA-recommended dose of 2.4 mL per single injection. These echocardiographic views of the right ventricle with ultrasound enhancing agent will be compared to the measurements made without the use of ultrasound enhancing agents, and the measurements made in MRI.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

January 2022

Completion Date

January 2023

Primary Completion Date

January 2023

Eligibility Criteria

        Inclusion Criteria:

          1. All patients aged 11 or greater who are referred to Nemours A.I. DuPont Hospital for
             Children for clinically indicated cardiac MRI will be eligible for inclusion.

          2. Informed written consent of parent or legal guardian.

          3. Informed written assent of subject, if appropriate.

        Exclusion Criteria:

          1. Any patients in which Lumason is contraindicated (i.e. prior anaphylactoid reaction)
             will be ineligible for the clinical ultrasound and ineligible for the study.

          2. History of allergic reaction to Lumason, sulfur hexaflouride, sulfur hexafluoride
             lipid microsphere components, or other ingredients in Lumason (polyethylene glycol,
             distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium
             (DPPG-Na), palmitic acid)

          3. Pregnant women will be excluded from the study as well since Lumason has not been
             studied in pregnancy.
      

Gender

All

Ages

11 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 3022684102, [email protected]



Administrative Informations


NCT ID

NCT05186415

Organization ID

1764041-1


Responsible Party

Principal Investigator

Study Sponsor

Nemours Children's Health System

Collaborators

 Thomas Jefferson University

Study Sponsor

, , 


Verification Date

January 2022