Normal Values for Myocardial Left Atrial Strain

March 12, 2019 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de La Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy controls.

Description

Inclusion Criteria:

  • No history of cardiopathy / pneumopathy.
  • No history of hypertension or mellitus diabetes.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 4 months.
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.
Through study completion, an average of 4 months.
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.
Through study completion, an average of 4 months.
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.
Through study completion, an average of 4 months.
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.
Through study completion, an average of 4 months.
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.
Through study completion, an average of 4 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age in years
Time Frame: Through study completion, an average of 4 months.
Through study completion, an average of 4 months.
Sex
Time Frame: Through study completion, an average of 4 months.
male or female
Through study completion, an average of 4 months.
Weight in kilograms
Time Frame: Through study completion, an average of 4 months.
Through study completion, an average of 4 months.
Height in meters
Time Frame: Through study completion, an average of 4 months.
Through study completion, an average of 4 months.
Left atrial volume
Time Frame: Through study completion, an average of 4 months.
Measured by biplanar volumetric method
Through study completion, an average of 4 months.
Left ventricular ejection fraction
Time Frame: Through study completion, an average of 4 months.
Measured by biplanar Simpson's method
Through study completion, an average of 4 months.
Left ventricular telediastolic volume
Time Frame: Through study completion, an average of 4 months.
Measured by Simpson's method
Through study completion, an average of 4 months.
Left ventricular dimensions
Time Frame: Through study completion, an average of 4 months.
Assessed by the following parameters: telediastolic diameter, interventricular septal thickness, posterior wall thickness (in mm)
Through study completion, an average of 4 months.
E/A ratio
Time Frame: Through study completion, an average of 4 months.
Transmitral flow profile.
Through study completion, an average of 4 months.
E/e' ratio
Time Frame: Through study completion, an average of 4 months.
Tissue doppler derived parameter.
Through study completion, an average of 4 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIBSP-STR-2018-111

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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