Automated Myocardial Performance Index Using Samsung HERA W10

Brief Title

Automated Myocardial Performance Index Using Samsung HERA W10

Official Title

Automated Myocardial Performance Index Before, During and After Fetal Surgeries Using Samsung HERA W10

Brief Summary

      Researchers are using Myocardial performance index (MPI) to assess fetal cardiac function
      before, during, and after fetal surgery in order to gain more knowledge about fetal cardiac
      function in high risk pregnancies and the relationship to outcomes of fetal surgical
      interventions.
    

Detailed Description

      This study will evaluate the cardiac function in fetuses with specific conditions before,
      during, and after fetal interventions using an automated myocardial performance index. It is
      hypothesized that automated MPI can used to diagnosis and predict fetal cardiac dysfunction
      in fetal surgeries.

      Ultrasound examination, including Doppler assessment, has served an axial rule in diagnosis
      and management of complex maternal-fetal conditions. Sonographic findings have been
      indicative of prognosis and have guided intervention at particular situations including
      intrauterine growth restriction and fetal alloimmunization. As researchers continue to
      investigate various sonographic parameters that would identify fetuses at increased risk of
      adverse outcomes, which would warrant intervention, fetal cardiac function has substantially
      attracted attention as a potential predictor of fetal status; subtle cardiac dysfunction may
      reflect functional adaptation to fetal insult.

      Myocardial performance index (MPI) is a Doppler derived sonographic tool that is used to
      assess global fetal cardiac function. Higher MPI values have been proven to indicate
      ventricular dysfunction. Several studies have adopted the use of MPI as a part of fetal
      echocardiography, either to study normal values among fetal population or to assess fetal
      cardiac dysfunction in high risk pregnancy and in response to fetal intervention. Initial
      results have correlated MPI to adverse outcomes particularly in the presence of maternal and
      fetal disorders.

      Fetal surgery is a unique stressful situation in which fetal cardiac function presents a
      critical aspect. In part, because underlying indications are commonly associated with
      clinically relevant myocardial dysfunction e.g. twin-to-twin transfusion syndrome (TTTS),
      congenital diaphragmatic hernia (CDH), neural tube defect (NTD) and lower urinary tract
      obstruction (LUTO). Moreover, surgery itself may be associated with significant fetal cardiac
      compromise. Therefore, perioperative (before, during and after the procedures) MPI may
      present a predictive parameter of fetal and neonatal outcomes in these high risk surgeries.
    


Study Type

Observational


Primary Outcome

Automated MPI can used to diagnosis and predict fetal cardiac dysfunction in fetal surgeries.


Condition

Twin to Twin Transfusion Syndrome

Intervention

Automated Myocardial Performance Index (MPI)

Study Arms / Comparison Groups

 Fetal Surgery Procedures
Description:  All pregnant women with a fetus diagnosed with a fetal abnormality and planning to undergo a fetal surgical procedure will be included in this single arm of the study.

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

Device

Estimated Enrollment

50

Start Date

September 16, 2019

Completion Date

June 30, 2022

Primary Completion Date

December 31, 2021

Eligibility Criteria

        Inclusion Criteria

        • Pregnant women, aged 18 years or older, with one of the following prenatal diagnoses:

          -  Monochorionic diamniotic twin pregnancies complicated with TTTS

          -  Fetuses with CDH, but no other structural or chromosomal abnormalities

          -  Fetuses with NTD, but no other structural or chromosomal abnormalities

          -  Fetuses with LUTO, but no other structural or chromosomal abnormalities

          -  That provide written Informed Consent and is willing to comply with protocol
             requirements

        Exclusion Criteria

          -  Presence of fetal cardiac anomalies, arrhythmias, associated morbid or lethal
             anomalies, chromosomal abnormalities

          -  Pregnancy complications that are known to impact fetal and neonatal outcomes (e.g.
             diabetes mellitus, hypertension, autoimmune disorders
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Rodrigo Ruano, MD, PhD, 507-293-1487, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04140669

Organization ID

18-005189


Responsible Party

Principal Investigator

Study Sponsor

Mayo Clinic


Study Sponsor

Rodrigo Ruano, MD, PhD, Principal Investigator, Mayo Clinic


Verification Date

October 2019