Fetal Cardiac Strain Imaging Research
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|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
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|
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|
|Estimated Enrollment :||60 participants|
|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|
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01993264
|Contact: Ricardo Pignatelli, MDfirstname.lastname@example.org|
|United States, Texas|
|Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Ricardo Pignatelli, MD email@example.com|
|Principal Investigator: Ricardo Pignatelli, MD|
|Principal Investigator:||Ricardo Pignatelli, MD||Baylor College of Medicine/Texas Children's Hospital|