EchocardiographyVStrain123PNCT04395014
Echocardiographic Assessment of Ventricular Strain During a Healthy Pregnancy in the First, Second, and Third Trimester.
An observational study of Echocardiography and Pregnancy Related Conditions, Unspecified, First Trimester, run by Miguel Ayala León at 1 site in Mexico.
Trial summary
Pregnancy is a physiological situation that produces transient preload and afterload changes. The heart is subjected to reversible morphological remodelings and hemodynamic and functional adaptations. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Echocardiography, Pregnancy Related Conditions, Unspecified, First Trimester, Pregnancy Related Conditions, Unspecified, Second Trimester
- What is being tested?
- 2D Echocardiography
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 1 Oct 2020to 31 Aug 2021
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy pregnant women that coursing the first trimester of pregnancy.
Who may be able to join
- Age ≥18 years and < 35
- Patients who coursing the first trimester of pregnancy
- No history or symptoms of cardiovascular or lung disease
- No ongoing or previous cardio or vasoactive treatment
- Normal ECG
- Normal physical examination
- Able to give informed consent
Who cannot join
- Poor acoustic window
- Obesity in the first trimester (body mass index [BMI], ≥30 kg/m2)
- Inability to provide consent.
- Tricuspid regurgitation more than mild
- Collagen disease
- Professional sports activity
- Twin pregnancy
- Hyperthyroidism
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Beneficencia Española de Puebla
Puebla City, 72090
Miguel Ayala León, Cardiolology, 5529625396, librocardiocritica.ma@gmail.com
Miguel Ayala León
About this study
Pregnancy is a physiological situation that produces transient preload and afterload changes. The heart is subjected to reversible morphological remodelings and hemodynamic and functional adaptations. The characterization and understanding of maternal cardiac function during normal pregnancy by echocardiography 2D is of clinical importance for the opportune recognition of cardiac pathology.
This study aims to investigate pregnancy-induced changes in ventricular strain in healthy pregnant women by echocardiography.
- Conditions
- Echocardiography, Pregnancy Related Conditions, Unspecified, First Trimester, Pregnancy Related Conditions, Unspecified, Second Trimester, Pregnancy Related Conditions, Unspecified, Third Trimester, Ventricle Remodeling
- Being tested
- 2D Echocardiography
- Keywords
- Strain ventricular, Pregnancy, Ventricular function
- Medical subject headings
- Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D EchocardiographyDiagnostic test
In this echocardiographic imaging acquisition protocol, the pregnancy patients, are colocated in the left lateral decubitus position on a clinical bed with the left arm flex and the hand behind the head. All the echocardiographic measurements are taken by the examiner in this position.
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular telediastolic diameter (LVTDd)
Left ventricular telediastolic diameter (mm)
Measured: 3 minutes
Left ventricular telesystolic diamete (LVTSd)
Left ventricular telesystolic diameter (mm)
Measured: 3 minutes
Interventricular septum (IVS)
Diameter of Interventricular septum (mm)
Measured: 3 minutes
Left ventricular posterior wall (LVPW)
Left ventricle posterior wall (mm)
Measured: 3 minutes
Ejection fraction (EF)
Ejection fraction (%)
Measured: 3 minutes
Right atrium area (RA area)
Right atrium area (cm2)
Measured: 3 minutes
Right ventricle B
Right ventricle basal dimension (mm)
Measured: 3 minutes
Right ventricular M
Right ventricle mid cavity dimension (mm)
Measured: 3 minutes
Right ventricular L
Right ventricle longitudinal dimension (mm)
Measured: 3 minutes
Right ventricle outflow tract dimension at the proximal subvalvular level (RVOT p)
Right ventricle outflow tract dimension at the proximal subvalvular level (mm)
Measured: 3 minutes
Right ventricle outflow tract dimension at the distal or pulmonic valve level (RVOT d)
Right ventricle outflow tract dimension at the distal or pulmonic valve level (mm)
Measured: 3 minutes
Tricuspid annular plane systolic excursion (TAPSE)
Tricuspid annular plane systolic excursion (mm)
Measured: 3 minutes
Right ventricle free wall (RV free wall)
Right ventricle free wall (mm)
Measured: 3 minutes
Inferior cava vein (ICV)
Inferior cava vein (mm)
Measured: 3 minutes
Left atrium volume index (LA volume index)
Left atrium volume index (mL/m2)
Measured: 3 minutes
E mitr
Mitral E wave (cm/s)
Measured: 3 minutes
A mitr
Mitral A wave (cm/s)
Measured: 3 minutes
E/A mitr
Mitral E wave / Mitral A wave
Measured: 3 minutes
Sm
S-wave at mitral anulus (cm/s)
Measured: 3 minutes
Em
E-wave at mitral annulus (cm/s)
Measured: 3 minutes
Am
A-wave at mitral annulus (cm/s)
Measured: 3 minutes
Em/Am
E-wave at mitral annulus/ A-wave at mitral annulus
Measured: 3 minutes
E/Em
E wave/ E-wave at the mitral annulus
Measured: 3 minutes
E tric
Tricuspid E wave (cm/s)
Measured: 3 minutes
A tric (cm/s)
Tricuspid A wave (cm/s)
Measured: 3 minutes
E/A tric
Tricuspid E wave/Tricuspid A wave
Measured: 3 minutes
St
S-wave at tricuspid anulus(cm/s)
Measured: 3 minutes
Et
E-wave at tricuspid anulus(cm/s)
Measured: 3 minutes
At
A-wave at tricuspid anulus (cm/s)
Measured: 3 minutes
Et/At
E-wave at tricuspid anulus /A-wave at tricuspid anulus
Measured: 3 minutes
Mean pulmonary artery pressure (mPAP)
Mean pulmonary artery pressure (mmHg)
Measured: 3 minutes
Systolic pulmonary artery pressure (sPAP)
Systolic pulmonary artery pressure (mmHg)
Measured: 3 minutes
Stroke volume (SV)
Stroke volume (mL)
Measured: 3 minutes
Cardiac output (CO)
Cardiac output (L/min)
Measured: 3 minutes
Strain right ventricle (Strain RV)
Strain right ventricle
Measured: 3 minutes
Strain left ventricle (Strain LV)
Strain left ventricle
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miguel Ayala León
- Sponsor type
- Research network
- Collaborators
- Leiden University Medical Center, Institute of Security and Social Services of Workers of the State of Puebla.
- Responsible party
- Sponsor-investigator, Miguel Ayala León, Hospital Beneficencia Espanola de Puebla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395014
- Sponsor's protocol ID
- Cardiology-003
- Acronym
- VStrain123P
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Assessment of Ventricular Strain During a Healthy Pregnancy in the First, Second, and Third Trimester.
- ClinicalTrials.gov ID
- NCT04395014
- Acronym / sponsor ID
- VStrain123P / Cardiology-003
- Conditions
- Echocardiography, Pregnancy Related Conditions, Unspecified, First Trimester, Pregnancy Related Conditions, Unspecified, Second Trimester, Pregnancy Related Conditions, Unspecified, Third Trimester, Ventricle Remodeling
- Keywords
- Strain ventricular, Pregnancy, Ventricular function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Miguel Ayala LeónResearch network
- Collaborators
- Leiden University Medical Center, Institute of Security and Social Services of Workers of the State of Puebla.
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 20 May 2020 (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.
Pregnancy is a physiological situation that produces transient preload and afterload changes. The heart is subjected to reversible morphological remodelings and hemodynamic and functional adaptations. The characterization and understanding of maternal cardiac function during normal pregnancy by echocardiography 2D is of clinical importance for the opportune recognition of cardiac pathology.
This study aims to investigate pregnancy-induced changes in ventricular strain in healthy pregnant women by echocardiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy pregnant women that coursing the first trimester of pregnancy.
Key inclusion criteria (7 listed)
- Age ≥18 years and < 35
- Patients who coursing the first trimester of pregnancy
- No history or symptoms of cardiovascular or lung disease
- No ongoing or previous cardio or vasoactive treatment
- Normal ECG
Key exclusion criteria (8 listed)
- Poor acoustic window
- Obesity in the first trimester (body mass index [BMI], ≥30 kg/m2)
- Inability to provide consent.
- Tricuspid regurgitation more than mild
- Collagen disease
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 |
|---|---|---|
| 2D EchocardiographyIn this echocardiographic imaging acquisition protocol, the pregnancy patients, are colocated in the left lateral decubitus position on a clinical bed with the left arm flex and the hand behind the head. All the echocardiographic measurements are taken by the examiner in this position. | Diagnostic test | – |
Primary outcome
Left ventricular telediastolic diameter (LVTDd)
Time frame: 3 minutes
Left ventricular telediastolic diameter (mm)
Left ventricular telesystolic diamete (LVTSd)
Time frame: 3 minutes
Left ventricular telesystolic diameter (mm)
Interventricular septum (IVS)
Time frame: 3 minutes
Diameter of Interventricular septum (mm)
Left ventricular posterior wall (LVPW)
Time frame: 3 minutes
Left ventricle posterior wall (mm)
Ejection fraction (EF)
Time frame: 3 minutes
Ejection fraction (%)
Right atrium area (RA area)
Time frame: 3 minutes
Right atrium area (cm2)
Right ventricle B
Time frame: 3 minutes
Right ventricle basal dimension (mm)
Right ventricular M
Time frame: 3 minutes
Right ventricle mid cavity dimension (mm)
Right ventricular L
Time frame: 3 minutes
Right ventricle longitudinal dimension (mm)
Right ventricle outflow tract dimension at the proximal subvalvular level (RVOT p)
Time frame: 3 minutes
Right ventricle outflow tract dimension at the proximal subvalvular level (mm)
Right ventricle outflow tract dimension at the distal or pulmonic valve level (RVOT d)
Time frame: 3 minutes
Right ventricle outflow tract dimension at the distal or pulmonic valve level (mm)
Tricuspid annular plane systolic excursion (TAPSE)
Time frame: 3 minutes
Tricuspid annular plane systolic excursion (mm)
Right ventricle free wall (RV free wall)
Time frame: 3 minutes
Right ventricle free wall (mm)
Inferior cava vein (ICV)
Time frame: 3 minutes
Inferior cava vein (mm)
Left atrium volume index (LA volume index)
Time frame: 3 minutes
Left atrium volume index (mL/m2)
E mitr
Time frame: 3 minutes
Mitral E wave (cm/s)
A mitr
Time frame: 3 minutes
Mitral A wave (cm/s)
E/A mitr
Time frame: 3 minutes
Mitral E wave / Mitral A wave
Sm
Time frame: 3 minutes
S-wave at mitral anulus (cm/s)
Em
Time frame: 3 minutes
E-wave at mitral annulus (cm/s)
Am
Time frame: 3 minutes
A-wave at mitral annulus (cm/s)
Em/Am
Time frame: 3 minutes
E-wave at mitral annulus/ A-wave at mitral annulus
E/Em
Time frame: 3 minutes
E wave/ E-wave at the mitral annulus
E tric
Time frame: 3 minutes
Tricuspid E wave (cm/s)
A tric (cm/s)
Time frame: 3 minutes
Tricuspid A wave (cm/s)
E/A tric
Time frame: 3 minutes
Tricuspid E wave/Tricuspid A wave
St
Time frame: 3 minutes
S-wave at tricuspid anulus(cm/s)
Et
Time frame: 3 minutes
E-wave at tricuspid anulus(cm/s)
At
Time frame: 3 minutes
A-wave at tricuspid anulus (cm/s)
Et/At
Time frame: 3 minutes
E-wave at tricuspid anulus /A-wave at tricuspid anulus
Mean pulmonary artery pressure (mPAP)
Time frame: 3 minutes
Mean pulmonary artery pressure (mmHg)
Systolic pulmonary artery pressure (sPAP)
Time frame: 3 minutes
Systolic pulmonary artery pressure (mmHg)
Stroke volume (SV)
Time frame: 3 minutes
Stroke volume (mL)
Cardiac output (CO)
Time frame: 3 minutes
Cardiac output (L/min)
Strain right ventricle (Strain RV)
Time frame: 3 minutes
Strain right ventricle
Strain left ventricle (Strain LV)
Time frame: 3 minutes
Strain left ventricle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: No
Related trials for Echocardiography
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Recruiting
Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians in Heart Failure
Heart Failure
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
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.
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 Echocardiography and Pregnancy Related Conditions, Unspecified, First Trimester, run by Miguel Ayala León at 1 site in Mexico.
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 7 inclusion and 8 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 20 May 2020. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miguel Ayala León, MD (5529625396, librocardiocritica.ma@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular telediastolic diameter (LVTDd) (time frame: 3 minutes). The study lists 36 primary outcomes in all. 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 20 May 2020.