Fetal Cardiac Strain Imaging Research

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Baylor College of Medicine
Sponsor:
Information provided by (Responsible Party):
Shiraz Maskatia, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01993264
First received: October 30, 2013
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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 Intervention
Myocardial Deformation
Other: Fetal Echocardiogram

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Standardization Of A Novel Method To Assess Fetal Cardiac Function: Myocardial Deformation Analysis

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Inter-observer variability of institutional imaging and analysis protocol [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Develop normative reference ranges for various measures of myocardial deformation (global left and right ventricular strain and strain rate) across gestation and after birth.


Estimated Enrollment: 60
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders 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.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01993264

Contacts
Contact: Shiraz Maskatia, MD 832-826-5752 samaskat@bcm.edu
Contact: Melissa Karlsten 832-826-5925 karlsten@bcm.edu

Locations
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Shiraz Maskatia, MD    832-826-5752    samaskat@bcm.edu   
Principal Investigator: Shiraz Maskatia, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Shiraz Maskatia, MD Baylor College of Medicine/Texas Children's Hospital
  More Information

No publications provided

Responsible Party: Shiraz Maskatia, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01993264     History of Changes
Other Study ID Numbers: H-33343
Study First Received: October 30, 2013
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Heart disease
Echocardiogram
Ultrasound
Heart defect
Heart Dysfunction
Pediatric Cardiologists
Prenatal

ClinicalTrials.gov processed this record on August 28, 2014