Fetal Cardiac Strain Imaging Research
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Standardization Of A Novel Method To Assess Fetal Cardiac Function: Myocardial Deformation Analysis|
- 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.
|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)|
Other: Fetal Echocardiogram
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01993264
|Contact: Shiraz Maskatia, MDfirstname.lastname@example.org|
|Contact: Melissa Karlstenemail@example.com|
|United States, Texas|
|Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Shiraz Maskatia, MD 832-826-5752 firstname.lastname@example.org|
|Principal Investigator: Shiraz Maskatia, MD|
|Principal Investigator:||Shiraz Maskatia, MD||Baylor College of Medicine/Texas Children's Hospital|