NCT02132585

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
Last Updated

May 7, 2014

Status Verified

February 1, 2014

Enrollment Period

3.2 years

First QC Date

May 5, 2014

Last Update Submit

May 5, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Association between 6minute-walking-test and Longitudinal strain reduction

    baseline, 24 weeks

Study Arms (2)

Sjogren

Sjogren Patients evaluated with Speckle tracking echocardiography

Procedure: Speckle tracking echocardiography

Control

Controls Speckle tracking echocardiography

Procedure: Speckle tracking echocardiography

Interventions

ControlSjogren

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients enrolled from cardiovascular clinic

You may qualify if:

  • Diagnosis of Sjogren Syndrome

You may not qualify if:

  • previous cardiovascular events
  • unstable angina
  • stroke
  • diagnosis of heart failure
  • incapacity to provide an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Galeazzi IRCCS of Milan

Milan, Italy, Italy

Location

Sapienza University

Rome, Italy

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 7, 2014

Study Start

January 1, 2010

Primary Completion

March 1, 2013

Study Completion

May 1, 2014

Last Updated

May 7, 2014

Record last verified: 2014-02

Locations