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Automated Myocardial Performance Index Using Samsung HERA W10

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ClinicalTrials.gov Identifier: NCT04140669
Recruitment Status : Terminated (Sponsor support and funding was terminated due to pandemic)
First Posted : October 28, 2019
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Rodrigo Ruano M.D., Ph.D, Mayo Clinic

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.

Condition or disease Intervention/treatment
Twin to Twin Transfusion Syndrome Congenital Diaphragmatic Hernia Neural Tube Defects Lower Urinary Tract Infection Device: Automated Myocardial Performance Index (MPI)

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.

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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Automated Myocardial Performance Index Before, During and After Fetal Surgeries Using Samsung HERA W10
Actual Study Start Date : September 16, 2019
Actual Primary Completion Date : July 7, 2020
Actual Study Completion Date : July 7, 2020


Group/Cohort Intervention/treatment
Fetal Surgery Procedures
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.
Device: Automated Myocardial Performance Index (MPI)
Automated Myocardial Performance Index will be performed using Samsung HERA W10 prior too fetal surgical interventions, during surgery, and following surgery.




Primary Outcome Measures :
  1. Automated MPI can used to diagnosis and predict fetal cardiac dysfunction in fetal surgeries. [ Time Frame: 48 hours post-operatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based on current pregnancy
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women carrying a fetus with a diagnosis of TTTS, fetal NTD, fetal CDH, or fetal LUTO, and planning to undergo a fetal surgical procedure.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140669


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Rodrigo Ruano, MD, PhD Mayo Clinic
Additional Information:
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Responsible Party: Rodrigo Ruano M.D., Ph.D, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04140669    
Other Study ID Numbers: 18-005189
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Urinary Tract Infections
Neural Tube Defects
Spinal Dysraphism
Fetofetal Transfusion
Hernias, Diaphragmatic, Congenital
Hernia, Diaphragmatic
Hernia
Pathological Conditions, Anatomical
Infections
Urologic Diseases
Internal Hernia
Congenital Abnormalities
Nervous System Malformations
Nervous System Diseases
Anemia, Neonatal
Anemia
Hematologic Diseases
Infant, Newborn, Diseases