Myocardial DeformationNCT01993264
Fetal Cardiac Strain Imaging Research
An observational study of Myocardial Deformation, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Myocardial Deformation
- What is being tested?
- Fetal Echocardiogram
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 3 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standardization Of A Novel Method To Assess Fetal Cardiac Function: Myocardial Deformation Analysis
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.
Read the 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.
- Conditions
- Myocardial Deformation
- Being tested
- Fetal Echocardiogram
- Keywords
- Heart disease, Echocardiogram, Ultrasound, Heart defect, Heart Dysfunction, Pediatric Cardiologists, Prenatal
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal EchocardiogramOther
Subjects will then have sequential, abbreviated fetal echocardiograms performed by designated, highly trained, and experienced sonographers every 4 weeks, from 20-36 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Normative reference ranges for various measures of myocardial deformation
Develop normative reference ranges for various measures of myocardial deformation (global left and right ventricular strain and strain rate) across gestation and after birth.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2013
- Primary completion3 Nov 2017
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial DeformationStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo H Pignatelli, Baylor College of Medicine
- Investigators
- Ricardo Pignatelli, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993264
- Sponsor's protocol ID
- H-33343
- Status last verified
- Mar 2022
- First submitted
- 30 Oct 2013
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization Of A Novel Method To Assess Fetal Cardiac Function: Myocardial Deformation Analysis
- ClinicalTrials.gov ID
- NCT01993264
- Acronym / sponsor ID
- H-33343
- Conditions
- Myocardial Deformation
- Keywords
- Heart disease, Echocardiogram, Ultrasound, Heart defect, Heart Dysfunction, Pediatric Cardiologists, Prenatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal EchocardiogramSubjects will then have sequential, abbreviated fetal echocardiograms performed by designated, highly trained, and experienced sonographers every 4 weeks, from 20-36 weeks. | Other | – |
Primary outcome
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.
1 secondary outcome
Normative reference ranges for various measures of myocardial deformation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Pignatelli, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Deformation, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-observer variability of institutional imaging and analysis protocol (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.