Fetal Cardiac Strain Imaging Research

NCT01993264 | Completed

• 1 other identifier: H-33343
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Deformation

Keywords

Heart disease; Echocardiogram; Ultrasound; Heart defect; Heart Dysfunction; Pediatric Cardiologists; Prenatal

Outcome Measures

Primary Outcomes (1)

• Inter-observer variability of institutional imaging and analysis protocol

  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.

  1 year

Secondary Outcomes (1)

• Normative reference ranges for various measures of myocardial deformation

  1 year

Interventions

Fetal Echocardiogram OTHER

Subjects will then have sequential, abbreviated fetal echocardiograms performed by designated, highly trained, and experienced sonographers every 4 weeks, from 20-36 weeks.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Ricardo Pignatelli, MD

  Baylor College of Medicine - Texas Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 25, 2013
• Study Start: October 1, 2013
• Primary Completion: November 3, 2017
• Study Completion: November 3, 2020
• Last Updated: March 2, 2022

Record last verified: 2022-03

Locations

US (1)