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
|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)|
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|
|Actual Enrollment :||7 participants|
|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|
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.
- Automated MPI can used to diagnosis and predict fetal cardiac dysfunction in fetal surgeries. [ Time Frame: 48 hours post-operatively ]
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
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Rodrigo Ruano, MD, PhD||Mayo Clinic|