Normal Values for Myocardial Left Atrial Strain

Atrial Function Clinical Trial

Official title:

Normal Values for Myocardial Left Atrial Strain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03874624
• Other study ID #: IIBSP-STR-2018-111
• Status: Recruiting
• Start date: February 22, 2019
• Est. completion date: May 31, 2019

Study information

• Verified date: March 2019
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Lidia Bos Real
• Phone: 0034935537058
• Email: lbos[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical 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). Studies performed in their department which meet the criteria for an adequate strain analysis will be retrospectively reviewed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Function

Intervention

Diagnostic Test:
• two-dimensional speckle tracking
Analysis of myocardial left atrial strain using two-dimensional speckle tracking echocardiography.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 4 months.
Primary	Global pump strain.	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.
Primary	Global conductance strain.	Measured as the difference between global reservoir strain and gobal pump strain.	Through study completion, an average of 4 months.
Primary	Global reservoir strain rate.	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.
Primary	Global conductance strain rate.	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.
Primary	Global pump strain rate.	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	Age in years		Through study completion, an average of 4 months.
Secondary	Sex	male or female	Through study completion, an average of 4 months.
Secondary	Weight in kilograms		Through study completion, an average of 4 months.
Secondary	Height in meters		Through study completion, an average of 4 months.
Secondary	Left atrial volume	Measured by biplanar volumetric method	Through study completion, an average of 4 months.
Secondary	Left ventricular ejection fraction	Measured by biplanar Simpson's method	Through study completion, an average of 4 months.
Secondary	Left ventricular telediastolic volume	Measured by Simpson's method	Through study completion, an average of 4 months.
Secondary	Left ventricular dimensions	Assessed by the following parameters: telediastolic diameter, interventricular septal thickness, posterior wall thickness (in mm)	Through study completion, an average of 4 months.
Secondary	E/A ratio	Transmitral flow profile.	Through study completion, an average of 4 months.
Secondary	E/e' ratio	Tissue doppler derived parameter.	Through study completion, an average of 4 months.