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

May 5, 2014 updated by: Gianturco Luigi, University of Roma La Sapienza

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

700

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

  • Italy
      • Milan, Italy
        • Galeazzi IRCCS of Milan
      • Rome, Italy
        • Sapienza University

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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients enrolled from cardiovascular clinic

Description

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 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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longitudinal Myocardial Strain reduction in Sjogren Patients
Time Frame: 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)
Baseline, 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between 6minute-walking-test and Longitudinal strain reduction
Time Frame: baseline, 24 weeks
Longitudinal strain reduction could be linked to decrease in cardiorespiratory fitness, especially in 6-minute-walking-test
baseline, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

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

January 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 5, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Spk-001

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.

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