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Fetal Cardiac Function Evaluation With aCMQ-Strain Fetal (STRAIN)

Evaluation of Fetal Cardiac Function With aCMQ-STRAIN: Normality Curve and Comparison to Fetus With Cardiac Disfunction Risk Factors

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03536000
Acronym
STRAIN
Enrollment
250
Registered
2018-05-24
Start date
2018-05-28
Completion date
2019-09-11
Last updated
2018-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Cardiac Disorder

Keywords

Cardiac function, Fetal, Strain

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTFetal echocardiography using the aCMQ-Strain method

Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients older than 18 years * Pregnant women\> 20 weeks gestation * Understand and accept the study procedures and sign an informed consent.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Changes in the shortening of cardiac fibers during cardiac cycleAt 24, 28, 32 and 36 weeks of gestationFetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification)

Contacts

Primary ContactElisa Llurba, PhD
ellurba@santpau.cat935537041
Backup ContactCarla Domínguez, MD
cdominguezg@santpau.cat687691793

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026