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

Fetal Cardiac Disorder Clinical Trial

— STRAIN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03536000
• Other study ID #: IIBSP-CMQ-2017-99
• Status: Not yet recruiting
• Start date: May 28, 2018
• Est. completion date: September 11, 2019

Study information

• Verified date: May 2018
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Elisa Llurba, PhD
• Phone: 935537041
• Email: ellurba[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: September 11, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Cardiac Disorder
• Heart Diseases
• Sprains and Strains

Intervention

Diagnostic Test:
• Fetal 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

References & Publications (3)

Comas M, Crispi F, Cruz-Martinez R, Martinez JM, Figueras F, Gratacós 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. — View Citation

Crispi F, Gratacós 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. Review. — View Citation

Van Mieghem T. Re: Descriptive analysis of different phenotypes of cardiac remodeling in fetal growth restriction. M. Rodríguez-López, M. Cruz-Lemini, B. Valenzuela-Alcaraz, L. Garcia-Otero, M. Sitges, B. Bijnens, E. Gratacós and F. Crispi. Ultrasound Obstet Gynecol 2017; 50: 207-214. Ultrasound Obstet Gynecol. 2017 Aug;50(2):154. doi: 10.1002/uog.17541. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the shortening of cardiac fibers during cardiac cycle	Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification)	At 24, 28, 32 and 36 weeks of gestation