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

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

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 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

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

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

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

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)

February 22, 2019

Primary Completion (Anticipated)

May 31, 2019

Study Completion (Anticipated)

May 31, 2019

Study Registration Dates

First Submitted

March 1, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 14, 2019

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID 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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