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

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ClinicalTrials.gov Identifier: NCT03536000
Recruitment Status : Not yet recruiting
First Posted : May 24, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Condition or disease Intervention/treatment
Fetal Cardiac Disorder Diagnostic Test: Fetal echocardiography using the aCMQ-Strain method

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.


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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Fetal Cardiac Function With aCMQ-STRAIN: Normality Curve and Comparison to Fetus With Cardiac Disfunction Risk Factors
Estimated Study Start Date : May 28, 2018
Estimated Primary Completion Date : April 11, 2019
Estimated Study Completion Date : September 11, 2019

Group/Cohort Intervention/treatment
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
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

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
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

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
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

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
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




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

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

Information from the National Library of Medicine

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): NCT03536000


Contacts
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Contact: Elisa Llurba, PhD 935537041 ellurba@santpau.cat
Contact: Carla Domínguez, MD 687691793 cdominguezg@santpau.cat

Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Principal Investigator: Elisa LLurba, PhD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications:
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03536000     History of Changes
Other Study ID Numbers: IIBSP-CMQ-2017-99
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Cardiac function
Fetal
Strain
Additional relevant MeSH terms:
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Heart Diseases
Sprains and Strains
Wounds and Injuries
Cardiovascular Diseases