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Fetal Cardiac Strain Imaging Research

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01993264
Recruitment Status : Unknown
Verified December 2016 by Ricardo H Pignatelli, Baylor College of Medicine.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : December 21, 2016
Information provided by (Responsible Party):
Ricardo H Pignatelli, Baylor College of Medicine

Brief Summary:

Cardiac disease in children may start early in life and evidence of cardiac disease can be seen during prenatal life. A variety of diseases diagnosed during fetal life can put children at risk for cardiac disease. The accurate assessment of cardiac function is important in these patients. A type of imaging scan called "fetal echocardiogram" is used to measure the contractility or squeeze of the heart. The fetal echocardiogram is a painless test and completely non-invasive.

This study aims to recruit women and fetuses to determine if this imaging scan can be used throughout the pregnancy to measure heart squeeze and develop normal values to help doctors better diagnose fetuses who may have cardiac disease before they are born.

Condition or disease Intervention/treatment
Myocardial Deformation Other: Fetal Echocardiogram

Detailed Description:

The subject will have to complete 6 fetal echocardiograms. A fetal echocardiogram is picture of the unborn baby's heart in motion made by bouncing sound waves off the heart and recording the echo. The procedure will be very similar to the ultrasounds that the subject is already receiving as part of her prenatal care.

The scans will start at week 20 of the subject's pregnancy and repeat every 3 weeks until week 38 of birth (whichever occurs first). The appointments will last approximately 30 minutes each and will be performed by one of two sonographers trained specifically in fetal echocardiography. One additional echocardiogram will be performed on the infant after birth, within the first two months of life. In addition to the scans, study staff will access the subject's medical record to collect information such as: age, ethnicity, race, medical history and health insurance status.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Standardization Of A Novel Method To Assess Fetal Cardiac Function: Myocardial Deformation Analysis
Study Start Date : October 2013
Actual Primary Completion Date : January 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Fetal Echocardiogram
    Subjects will then have sequential, abbreviated fetal echocardiograms performed by designated, highly trained, and experienced sonographers every 4 weeks, from 20-36 weeks.

Primary Outcome Measures :
  1. Inter-observer variability of institutional imaging and analysis protocol [ Time Frame: 1 year ]
    Determine the inter-observer variability of our imaging and analysis protocol for the measurement of fetal myocardial deformation throughout gestation and after birth. The investigator will use the paired t-test to compare differences in measurement between the two observers at each time point.

Secondary Outcome Measures :
  1. Normative reference ranges for various measures of myocardial deformation [ Time Frame: 1 year ]
    Develop normative reference ranges for various measures of myocardial deformation (global left and right ventricular strain and strain rate) across gestation and after birth.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at the obstetrics clinic at Texas Children's Hospital Pavilion for Women at the time of their second trimester screening ultrasound will be asked to volunteer to take part in the study.

Inclusion Criteria:

  • Patient at the obstetrics clinic at Texas Children's Hospital Pavilion for Women at the time of their second trimester screening ultrasound
  • Fetus must have no recognizable disease at the second trimester screening ultrasound
  • Willing to participate in a total of 5 fetal echocardiograms and one within 2 months after delivery
  • English or Spanish literacy
  • A four chamber view of the heart must be visible upon screening examination
  • No fetal anatomic or growth abnormalities suspected on screening examination.

Exclusion Criteria:

  • Subjects that meet the cutoff point for maternal obesity (BMI>30) and have identified risk factors for fetal cardiac dysfunction as determined by medical team.

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 identifier (NCT number): NCT01993264

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Contact: Ricardo Pignatelli, MD

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United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Ricardo Pignatelli, MD   
Principal Investigator: Ricardo Pignatelli, MD         
Sponsors and Collaborators
Baylor College of Medicine
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Principal Investigator: Ricardo Pignatelli, MD Baylor College of Medicine/Texas Children's Hospital
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Responsible Party: Ricardo H Pignatelli, Assistant Professor, Baylor College of Medicine Identifier: NCT01993264    
Other Study ID Numbers: H-33343
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Keywords provided by Ricardo H Pignatelli, Baylor College of Medicine:
Heart disease
Heart defect
Heart Dysfunction
Pediatric Cardiologists