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

• Conditions: Sjogren Syndrome
• Interventions: Procedure: Speckle tracking echocardiography

• Registration Number: NCT02132585
• Lead Sponsor: University of Roma La Sapienza

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2013-03
• Status Verified: 2014-02
• Study Completion: 2014-05
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-05
• Last Update Submitted: 2014-05-05
• Study First Posted: 2014-05-07
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sjogren	Speckle tracking echocardiography	Sjogren Patients evaluated with Speckle tracking echocardiography
Control	Speckle tracking echocardiography	Controls Speckle tracking echocardiography

Primary Outcome Measures

Name	Time	Method
Longitudinal Myocardial Strain reduction in Sjogren Patients	Baseline, 24 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Association between 6minute-walking-test and Longitudinal strain reduction	baseline, 24 weeks	Longitudinal strain reduction could be linked to decrease in cardiorespiratory fitness, especially in 6-minute-walking-test

Trial Locations

Locations (2)

Sapienza University; 🇮🇹 Rome, Italy

Galeazzi IRCCS of Milan; 🇮🇹 Milan, Italy