Cross-sectional Study of Use of Speckle Method in Early Diagnosis of Cardiovascular Dysfunction

Sjogren Syndrome Clinical Trial

— SPEEDCARS  

Official title:

Cross Sectional Study of Use of Speckle Tracking Echocardiography in the Early Diagnosis of Cardiovascular Dysfunction and Performance in Sjogren Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02132585
• Other study ID #: Spk-001
• Status: Active, not recruiting
• Phase: N/A
• First received: May 5, 2014
• Last updated: May 5, 2014
• Start date: January 2010
• Est. completion date: May 2014

Study information

• Verified date: February 2014
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Istituto Superiore di Sanità: Italy
• Study type: Observational

Clinical Trial Summary

Speckle tracking (STE) is a novel echocardiographic technique which permits calculation of myocardial velocities and deformation parameters such as strain and strain rate (SR). It is demonstrated that these parameters provide important insights into systolic and diastolic function, ischaemia, myocardial mechanics and many other pathophysiological processes of the heart. In this preliminary study, we investigated the role of STE in detection of early ventricular dysfunction in patients with Sjogren Syndrome, focusing on cardiorespiratory fitness.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: May 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Sjogren Syndrome

Exclusion Criteria:

• previous cardiovascular events

• unstable angina

• stroke

• diagnosis of heart failure

• incapacity to provide an informed consent

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Sjogren Syndrome
• Sjogren's Syndrome

Intervention

Procedure:
• Speckle tracking echocardiography

Locations

Country	Name	City	State
Italy	Galeazzi IRCCS of Milan	Milan
Italy	Sapienza University	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal Myocardial Strain reduction in Sjogren Patients	Longitudinal Myocardial Strain reduction could be an early marker of cardiac dysfunction in patients with Sjogren Syndrome, significantly better than common measurement (such as ejection fraction)	Baseline, 24 weeks	No
Secondary	Association between 6minute-walking-test and Longitudinal strain reduction	Longitudinal strain reduction could be linked to decrease in cardiorespiratory fitness, especially in 6-minute-walking-test	baseline, 24 weeks	No