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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Ricardo H Pignatelli, Baylor College of Medicine

Tracking Information
First Submitted Date October 30, 2013
First Posted Date November 25, 2013
Last Update Posted Date December 21, 2016
Study Start Date October 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2016)
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.
Original Primary Outcome Measures
 (submitted: November 20, 2013)
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures
 (submitted: December 19, 2016)
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fetal Cardiac Strain Imaging Research
Official Title Standardization Of A Novel Method To Assess Fetal Cardiac Function: Myocardial Deformation Analysis
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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Myocardial Deformation
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 20, 2013)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2016
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01993264
Other Study ID Numbers H-33343
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ricardo H Pignatelli, Baylor College of Medicine
Study Sponsor Baylor College of Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Ricardo Pignatelli, MD Baylor College of Medicine/Texas Children's Hospital
PRS Account Baylor College of Medicine
Verification Date December 2016