Atrial FunctionNCT03874624
Normal Values for Myocardial Left Atrial Strain
An observational study of Atrial Function, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Transversal retrospective and unicentric study. The investigators sought to determine the normal values for two-dimensional myocardial left atrial strain for the cardiology ultrasound system available in their centre (Philips EPIQ ultrasound machine and 10.8.5 QLAB cardiac analysis software). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Function
- What is being tested?
- two-dimensional speckle tracking
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 22 Feb 2019to 31 May 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls.
Who may be able to join
- No history of cardiopathy / pneumopathy.
- No history of hypertension or mellitus diabetes.
Who cannot join
- Pregnancy.
- Athletes.
- Body mass index < 16 or => 30 kg/m2.
- Previous treatment with cardiotoxic chemotherapy.
- Dilated left ventricle (telediastolic diameter index > 30 mm/m2).
- Interventricular septal thickness => 12 mm.
Show all 11Show fewer
- Dilated left atria (volume => 31 ml/m2).
- Systolic pulmonary pressure => 35 mmHg.
- Moderate or severe valvulopathy.
- Incomplete or suboptimal left atrial visualization.
- Frame rate < 50 fps.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
About this study
Transversal retrospective and unicentric study. The investigators sought to determine the normal values for two-dimensional myocardial left atrial strain for the cardiology ultrasound system available in their centre (Philips EPIQ ultrasound machine and 10.8.5 QLAB cardiac analysis software). Studies performed in their department which meet the criteria for an adequate strain analysis will be retrospectively reviewed.
- Conditions
- Atrial Function
- Being tested
- two-dimensional speckle tracking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two-dimensional speckle trackingDiagnostic test
Analysis of myocardial left atrial strain using two-dimensional speckle tracking echocardiography.
What is being measured
The primary outcome is the main question the study is designed to answer.
Global peak reservoir strain.
Percentage of peak reservoir strain for 4-, 2- and 3-chambers will be combined to report percentage of global peak reservoir strain.
Measured: Through study completion, an average of 4 months.
Global pump strain.
Percentage of pump reservoir strain for 4-, 2- and 3-chambers will be combined to report percentage of global pump strain.
Measured: Through study completion, an average of 4 months.
Global conductance strain.
Measured as the difference between global reservoir strain and gobal pump strain.
Measured: Through study completion, an average of 4 months.
Global reservoir strain rate.
Reservoir strain rate for 4-, 2- and 3-chambers will be combined to report global reservoir strain rate.
Measured: Through study completion, an average of 4 months.
Global conductance strain rate.
Conductance strain rate for 4-, 2- and 3-chambers will be combined to report global conductance strain rate.
Measured: Through study completion, an average of 4 months.
Global pump strain rate.
Pump strain rate for 4-, 2- and 3-chambers will be combined to report global pump strain rate.
Measured: Through study completion, an average of 4 months.
Secondary outcomes (10)
Age in years
Measured: Through study completion, an average of 4 months.
Sex
male or female
Measured: Through study completion, an average of 4 months.
Weight in kilograms
Measured: Through study completion, an average of 4 months.
Height in meters
Measured: Through study completion, an average of 4 months.
Left atrial volume
Measured by biplanar volumetric method
Measured: Through study completion, an average of 4 months.
Left ventricular ejection fraction
Measured by biplanar Simpson's method
Measured: Through study completion, an average of 4 months.
Left ventricular telediastolic volume
Measured by Simpson's method
Measured: Through study completion, an average of 4 months.
Left ventricular dimensions
Assessed by the following parameters: telediastolic diameter, interventricular septal thickness, posterior wall thickness (in mm)
Measured: Through study completion, an average of 4 months.
E/A ratio
Transmitral flow profile.
Measured: Through study completion, an average of 4 months.
E/e' ratio
Tissue doppler derived parameter.
Measured: Through study completion, an average of 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start22 Feb 2019
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FunctionStudies 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
- Retrospective
- Enrolment
- 43 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874624
- Sponsor's protocol ID
- IIBSP-STR-2018-111
- Status last verified
- Mar 2019
- First submitted
- 1 Mar 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Values for Myocardial Left Atrial Strain
- ClinicalTrials.gov ID
- NCT03874624
- Acronym / sponsor ID
- IIBSP-STR-2018-111
- Conditions
- Atrial Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 14 Mar 2019 (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.
Transversal retrospective and unicentric study. The investigators sought to determine the normal values for two-dimensional myocardial left atrial strain for the cardiology ultrasound system available in their centre (Philips EPIQ ultrasound machine and 10.8.5 QLAB cardiac analysis software). Studies performed in their department which meet the criteria for an adequate strain analysis will be retrospectively reviewed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls.
Key inclusion criteria (2 listed)
- No history of cardiopathy / pneumopathy.
- No history of hypertension or mellitus diabetes.
Key exclusion criteria (11 listed)
- Pregnancy.
- Athletes.
- Body mass index < 16 or => 30 kg/m2.
- Previous treatment with cardiotoxic chemotherapy.
- Dilated left ventricle (telediastolic diameter index > 30 mm/m2).
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 |
|---|---|---|
| two-dimensional speckle trackingAnalysis of myocardial left atrial strain using two-dimensional speckle tracking echocardiography. | Diagnostic test | – |
Primary outcome
Global peak reservoir strain.
Time frame: Through study completion, an average of 4 months.
Percentage of peak reservoir strain for 4-, 2- and 3-chambers will be combined to report percentage of global peak reservoir strain.
Global pump strain.
Time frame: Through study completion, an average of 4 months.
Percentage of pump reservoir strain for 4-, 2- and 3-chambers will be combined to report percentage of global pump strain.
Global conductance strain.
Time frame: Through study completion, an average of 4 months.
Measured as the difference between global reservoir strain and gobal pump strain.
Global reservoir strain rate.
Time frame: Through study completion, an average of 4 months.
Reservoir strain rate for 4-, 2- and 3-chambers will be combined to report global reservoir strain rate.
Global conductance strain rate.
Time frame: Through study completion, an average of 4 months.
Conductance strain rate for 4-, 2- and 3-chambers will be combined to report global conductance strain rate.
Global pump strain rate.
Time frame: Through study completion, an average of 4 months.
Pump strain rate for 4-, 2- and 3-chambers will be combined to report global pump strain rate.
10 secondary outcomes
Age in years
Time frame: Through study completion, an average of 4 months.
Sex
Time frame: Through study completion, an average of 4 months.
Weight in kilograms
Time frame: Through study completion, an average of 4 months.
Height in meters
Time frame: Through study completion, an average of 4 months.
Left atrial volume
Time frame: Through study completion, an average of 4 months.
Left ventricular ejection fraction
Time frame: Through study completion, an average of 4 months.
Left ventricular telediastolic volume
Time frame: Through study completion, an average of 4 months.
Left ventricular dimensions
Time frame: Through study completion, an average of 4 months.
E/A ratio
Time frame: Through study completion, an average of 4 months.
E/e' ratio
Time frame: Through study completion, an average of 4 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
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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.
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 Atrial Function, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 2 inclusion and 11 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 14 Mar 2019. 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 Spain. 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 Lidia Bos Real (0034935537058, lbos@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global peak reservoir strain. (time frame: Through study completion, an average of 4 months.). The study lists 6 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 14 Mar 2019.