Sjogren SyndromeSPEEDCARSNCT02132585
Cross-sectional Study of Use of Speckle Method in Early Diagnosis of Cardiovascular Dysfunction
An observational study of Sjogren Syndrome, run by University of Roma La Sapienza at 2 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sjogren Syndrome
- What is being tested?
- Speckle tracking echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2010to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients enrolled from cardiovascular clinic
Who may be able to join
- Diagnosis of Sjogren Syndrome
Who cannot join
- previous cardiovascular events
- unstable angina
- stroke
- diagnosis of heart failure
- incapacity to provide an informed consent
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Sjogren Syndrome
- Being tested
- Speckle tracking echocardiography
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speckle tracking echocardiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sjogren | Sjogren Patients evaluated with Speckle tracking echocardiography Receives: Procedure: Speckle tracking echocardiography | |
| Control | Controls Speckle tracking echocardiography Receives: Procedure: Speckle tracking echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 24 weeks
Secondary outcomes (1)
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
Measured: baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startJan 2010
- Primary completionMar 2013
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren SyndromeStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianturco Luigi, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132585
- Sponsor's protocol ID
- Spk-001
- Acronym
- SPEEDCARS
- Status last verified
- Feb 2014
- First submitted
- 5 May 2014
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Sectional Study of Use of Speckle Tracking Echocardiography in the Early Diagnosis of Cardiovascular Dysfunction and Performance in Sjogren Patients
- ClinicalTrials.gov ID
- NCT02132585
- Acronym / sponsor ID
- SPEEDCARS / Spk-001
- Conditions
- Sjogren Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2014 (estimated)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sjogren | – | Procedure: Speckle tracking echocardiographySjogren Patients evaluated with Speckle tracking echocardiography |
| Control | – | Procedure: Speckle tracking echocardiographyControls Speckle tracking echocardiography |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients enrolled from cardiovascular clinic
Key inclusion criteria (1 listed)
- Diagnosis of Sjogren Syndrome
Key exclusion criteria (5 listed)
- previous cardiovascular events
- unstable angina
- stroke
- diagnosis of heart failure
- incapacity to provide an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speckle tracking echocardiography | Procedure or surgery | Control, Sjogren |
Primary outcome
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)
1 secondary outcome
Association between 6minute-walking-test and Longitudinal strain reduction
Time frame: baseline, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren Syndrome, run by University of Roma La Sapienza at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal Myocardial Strain reduction in Sjogren Patients (time frame: Baseline, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.