- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03874624
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 Locations
-
-
-
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.
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.