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

• Sponsor: University of Roma La Sapienza (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02132585
• Collaborator: (none)
• Enrollment: 700
• Locations: 2
• Duration (Months): 51.9
• Patients Per Site: 350
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sjogren Syndrome	Procedure: Speckle tracking echocardiography

Study Design

• Study Type: Observational
• Anticipated Enrollment: 700 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Cross Sectional Study of Use of Speckle Tracking Echocardiography in the Early Diagnosis of Cardiovascular Dysfunction and Performance in Sjogren Patients
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Mar 1, 2013
• Anticipated Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Sjogren Sjogren Patients evaluated with Speckle tracking echocardiography	Procedure: Speckle tracking echocardiography
Control Controls Speckle tracking echocardiography	Procedure: Speckle tracking echocardiography

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Diagnosis of Sjogren Syndrome

Exclusion Criteria:

• previous cardiovascular events

• unstable angina

• stroke

• diagnosis of heart failure

• incapacity to provide an informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Galeazzi IRCCS of Milan	Milan		Italy
2	Sapienza University	Rome		Italy

Sponsors and Collaborators

• University of Roma La Sapienza

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gianturco Luigi, MD, University of Roma La Sapienza
• ClinicalTrials.gov Identifier: NCT02132585
• Other Study ID Numbers: Spk-001
• First Posted: May 7, 2014
• Last Update Posted: May 7, 2014
• Last Verified: Feb 1, 2014

• Additional relevant MeSH terms: Sjogren's Syndrome

Study Results

No Results Posted as of May 7, 2014