Fetal Cardiac DisorderSTRAINNCT03536000
Fetal Cardiac Function Evaluation With aCMQ-Strain Fetal (STRAIN)
An observational study of Fetal Cardiac Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
To assess whether the aCQM-Strain ultrasound method allows a good analysis of fetal cardiac function. Establish normality parameters and compare it with fetuses with risk factors of cardiac dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Cardiac Disorder
- What is being tested?
- Fetal echocardiography using the aCMQ-Strain method
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 28 May 2018to 11 Sep 2019
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Those healthy pregnant women who come to our hospital to perform the morphological ultrasound of the 2nd trimester, or pregnant women with pregestational diabetes, or with a diagnosis of intrauterine growth restriction and / or preeclampsia will be invited to participate in the study. For this, the Participant Information sheet in the study will be provided and the Informed Consent will be signed. Those patients who wish to participate in the study will be cited for the performance of an echocardiography using the aCMQ-Strain method at week 24, 28, 32 and 36 of gestation. All the tests will be carried out in the same study center and will be carried out by independent scouts.
Who may be able to join
- Patients older than 18 years
- Pregnant women> 20 weeks gestation
- Understand and accept the study procedures and sign an informed consent.
Who cannot join
- Not being able to understand the nature of the study and / or the procedures to be followed.
- Not signing informed consent
- Under 18 years of age
- Not pregnant
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Fetal Cardiac Function With aCMQ-STRAIN: Normality Curve and Comparison to Fetus With Cardiac Disfunction Risk Factors
To assess whether the aCQM-Strain ultrasound method allows a good analysis of fetal cardiac function. Establish normality parameters and compare it with fetuses with risk factors of cardiac dysfunction.
Read the detailed description
National unicentric observational study of follow-up study of a cohort. It has been decided to conduct a study of consecutive cases, including all patients who meet the inclusion criteria during the time of the study.
Until now, there has not been an easy and convenient method to determine fetal cardiac function. Recently a new Software (Automated Cardiac Motion Quantification aCMQ) has been developed, and it seems that allows an easier analysis of this one.
This study aims to analyze fetal heart function with the Strain method in healthy patients and then compare it with fetuses with risk factors for cardiac dysfunction.
Initially, healthy pregnant patients who agree to participate in the study will be cited, after signing the informed consent, in order to evaluate the normal fetal cardiac function and see how it is modified in the different weeks of gestation.
To do this, a fetal echocardiography will be performed by the investigators at week 24, 28, 32 and 36 of pregnancy, using the aCMQ-Strain method.
Once the investigators have established normality curves, fetuses with risk factors for cardiac dysfunction of women who agree to participate in the study will be analyzed. For this purpose, a fetal echocardiography at week 24, 28, 32 and 36 of gestation, using the aCMQ-Strain method will be performed.
All tests will be carried out in the same study center and will be carried out by independent scouts.The data obtained in each test will be collected in an anonymized database for further study.
- Conditions
- Fetal Cardiac Disorder
- Being tested
- Fetal echocardiography using the aCMQ-Strain method
- Keywords
- Cardiac function, Fetal, Strain
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal echocardiography using the aCMQ-Strain methodDiagnostic test
Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation
| Study group | Role | What they receive |
|---|---|---|
| Healthy women | * 200 Pregnant women
* Over 18 years
* Healthy
* With the ability to understand and sign the informed Consent
* With the ability to attend the established controls
* Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation Receives: Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method | |
| Intrauterine Growth restriction | * Pregnant women
* Over 18 years
* Intrauterine Growth Reestriction(IUGR): fetuses with percentile Growth <p3 or <p10 with vascular Doppler alteration.
* With the ability to understand and sign the informed Consent
* With the ability to attend the established controls
* Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation Receives: Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method | |
| Preeclampsia | * Pregnant women
* Over 18 years
* Preeclampsia: elevated blood pressure + Ratio Prot/Creatinin in urine> 30 mg / mmol creatinin
* With the ability to understand and sign the informed Consent
* With the ability to attend the established controls
* Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation Receives: Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method | |
| Diabetes Mellitus type 1 | * Pregnant women
* Over 18 years
* Diabetes mellitus type1
* With the ability to understand and sign the informed Consent
* With the ability to attend the established controls
* Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation Receives: Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the shortening of cardiac fibers during cardiac cycle
Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification)
Measured: At 24, 28, 32 and 36 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start28 May 2018 (estimated)
- Primary completion11 Apr 2019 (estimated)
- Study completion11 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fetal Cardiac DisorderStudies of the same condition, open and under way.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa LLurba, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536000
- Sponsor's protocol ID
- IIBSP-CMQ-2017-99
- Acronym
- STRAIN
- Status last verified
- May 2018
- First submitted
- 3 May 2018
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Van Mieghem T. Re: Descriptive analysis of different phenotypes of cardiac remodeling in fetal growth restriction. M. Rodriguez-Lopez, M. Cruz-Lemini, B. Valenzuela-Alcaraz, L. Garcia-Otero, M. Sitges, B. Bijnens, E. Gratacos and F. Crispi. Ultrasound Obstet Gynecol 2017; 50: 207-214. Ultrasound Obstet Gynecol. 2017 Aug;50(2):154. doi: 10.1002/uog.17541. No abstract available.
PubMed 28782233Crispi F, Gratacos E. Fetal cardiac function: technical considerations and potential research and clinical applications. Fetal Diagn Ther. 2012;32(1-2):47-64. doi: 10.1159/000338003. Epub 2012 May 17.
PubMed 22614129Comas M, Crispi F, Cruz-Martinez R, Martinez JM, Figueras F, Gratacos E. Usefulness of myocardial tissue Doppler vs conventional echocardiography in the evaluation of cardiac dysfunction in early-onset intrauterine growth restriction. Am J Obstet Gynecol. 2010 Jul;203(1):45.e1-7. doi: 10.1016/j.ajog.2010.02.044. Epub 2010 May 10.
PubMed 20451892
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fetal Cardiac Function With aCMQ-STRAIN: Normality Curve and Comparison to Fetus With Cardiac Disfunction Risk Factors
- ClinicalTrials.gov ID
- NCT03536000
- Acronym / sponsor ID
- STRAIN / IIBSP-CMQ-2017-99
- Conditions
- Fetal Cardiac Disorder
- Keywords
- Cardiac function, Fetal, Strain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 28 May 2018 (estimated)
- Primary completion
- 11 Apr 2019 (estimated)
- Study completion
- 11 Sep 2019 (estimated)
- First posted
- 24 May 2018 (actual)
- 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.
To assess whether the aCQM-Strain ultrasound method allows a good analysis of fetal cardiac function. Establish normality parameters and compare it with fetuses with risk factors of cardiac dysfunction.
Detailed description
National unicentric observational study of follow-up study of a cohort. It has been decided to conduct a study of consecutive cases, including all patients who meet the inclusion criteria during the time of the study.
Until now, there has not been an easy and convenient method to determine fetal cardiac function. Recently a new Software (Automated Cardiac Motion Quantification aCMQ) has been developed, and it seems that allows an easier analysis of this one.
This study aims to analyze fetal heart function with the Strain method in healthy patients and then compare it with fetuses with risk factors for cardiac dysfunction.
Initially, healthy pregnant patients who agree to participate in the study will be cited, after signing the informed consent, in order to evaluate the normal fetal cardiac function and see how it is modified in the different weeks of gestation.
To do this, a fetal echocardiography will be performed by the investigators at week 24, 28, 32 and 36 of pregnancy, using the aCMQ-Strain method.
Once the investigators have established normality curves, fetuses with risk factors for cardiac dysfunction of women who agree to participate in the study will be analyzed. For this purpose, a fetal echocardiography at week 24, 28, 32 and 36 of gestation, using the aCMQ-Strain method will be performed.
All tests will be carried out in the same study center and will be carried out by independent scouts.The data obtained in each test will be collected in an anonymized database for further study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy women | – | Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method* 200 Pregnant women * Over 18 years * Healthy * With the ability to understand and sign the informed Consent * With the ability to attend the established controls * Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation |
| Intrauterine Growth restriction | – | Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method* Pregnant women * Over 18 years * Intrauterine Growth Reestriction(IUGR): fetuses with percentile Growth <p3 or <p10 with vascular Doppler alteration. * With the ability to understand and sign the informed Consent * With the ability to attend the established controls * Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation |
| Preeclampsia | – | Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method* Pregnant women * Over 18 years * Preeclampsia: elevated blood pressure + Ratio Prot/Creatinin in urine> 30 mg / mmol creatinin * With the ability to understand and sign the informed Consent * With the ability to attend the established controls * Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation |
| Diabetes Mellitus type 1 | – | Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method* Pregnant women * Over 18 years * Diabetes mellitus type1 * With the ability to understand and sign the informed Consent * With the ability to attend the established controls * Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Those healthy pregnant women who come to our hospital to perform the morphological ultrasound of the 2nd trimester, or pregnant women with pregestational diabetes, or with a diagnosis of intrauterine growth restriction and / or preeclampsia will be invited to participate in the study. For this, the Participant Information sheet in the study will be provided and the Informed Consent will be signed. Those patients who wish to participate in the study will be cited for the performance of an echocardiography using the aCMQ-Strain method at week 24, 28, 32 and 36 of gestation. All the tests will be carried out in the same study center and will be carried out by independent scouts.
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Pregnant women> 20 weeks gestation
- Understand and accept the study procedures and sign an informed consent.
Key exclusion criteria (4 listed)
- Not being able to understand the nature of the study and / or the procedures to be followed.
- Not signing informed consent
- Under 18 years of age
- Not pregnant
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 echocardiography using the aCMQ-Strain methodFetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation | Diagnostic test | Diabetes Mellitus type 1, Healthy women, Intrauterine Growth restriction, Preeclampsia |
Primary outcome
Changes in the shortening of cardiac fibers during cardiac cycle
Time frame: At 24, 28, 32 and 36 weeks of gestation
Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Background: PubMed 28782233Van Mieghem T. Re: Descriptive analysis of different phenotypes of cardiac remodeling in fetal growth restriction. M. Rodriguez-Lopez, M. Cruz-Lemini, B. Valenzuela-Alcaraz, L. Garcia-Otero, M. Sitges, B. Bijnens, E. Gratacos and F. Crispi. Ultrasound Obstet Gynecol 2017; 50: 207-214. Ultrasound Obstet Gynecol. 2017 Aug;50(2):154. doi: 10.1002/uog.17541. No abstract available.
- Background: PubMed 22614129Crispi F, Gratacos E. Fetal cardiac function: technical considerations and potential research and clinical applications. Fetal Diagn Ther. 2012;32(1-2):47-64. doi: 10.1159/000338003. Epub 2012 May 17.
- Background: PubMed 20451892Comas M, Crispi F, Cruz-Martinez R, Martinez JM, Figueras F, Gratacos E. Usefulness of myocardial tissue Doppler vs conventional echocardiography in the evaluation of cardiac dysfunction in early-onset intrauterine growth restriction. Am J Obstet Gynecol. 2010 Jul;203(1):45.e1-7. doi: 10.1016/j.ajog.2010.02.044. Epub 2010 May 10.
- Individual participant dataSharing planned: Undecided
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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.
Elisa LLurba, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Cardiac Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Llurba, PhD (935537041, ellurba@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the shortening of cardiac fibers during cardiac cycle (time frame: At 24, 28, 32 and 36 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03536000, which also lists 3 linked publications.
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 24 May 2018.