Thrombosis of Left Atrial AppendageNCT02500745
Left Atrial Volume Index and Left Atrial Appendage Flow Velocities
An observational study of Thrombosis of Left Atrial Appendage, run by University of Cincinnati at 1 site in United States.
Trial summary
After obtaining a consent, bed side cardiac ultrasonography will be performed for cases undergoing transesophageal echocardiography to evaluate the correlation between left atrium volume and left atrial appendage flow velocity which can predict the thrombosis risk. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thrombosis of Left Atrial Appendage
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for transesophageal echocardiography
Who may be able to join
- Study will include all patients 18-80 years of age and referred for transesophageal evaluation of left atrium or left atrium appendage for appropriate clinical indications, at the University of Cincinnati University Medical Center and VA Medical Center.
Who cannot join
- Patients with either moderate to sever mitral valve disease or previous prosthetic mitral replacement.
- Patients with acute heart failure
- History of previous left atrium appendage surgical intervention.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Elsayed Abo-salem contact
United States1 site
University of cincinnati medical center
Cincinnati, Ohio, 45267
About this study
After obtaining a consent, bed side cardiac ultrasonography will be performed for cases undergoing transesophageal echocardiography to evaluate the correlation between left atrium volume and left atrial appendage flow velocity which can predict the thrombosis risk.
Read the detailed description
Informed consent will be obtained prior to any research related procedures Prior to performing the transesophageal echocardiography, 4 and a 2-chamber transthoracic images will be obtained to perform standard left atrial volumetric assessment as well as speckle tracking interrogation. Both these procedures will be performed offline. The transesophageal echocardiography will be performed using available equipment with a 5- to 7-megaHertz multiplane transducer and according to standard of care. All images will be acquired per American Society of Echocardiography guidelines and will be recorded for further analysis. The left atrial appendage will be best visualized in the 60, 90 and 110 degree imaging planes and left atrial appendage contraction velocity will be recorded by placing a pulsed wave Doppler sample volume inside the proximal third of the left atrial appendage at each angle. In addition, images will be recorded using a 3-beat cycle capture to later perform offline velocity vector imaging analysis for left atrial appendage speckle tracking analysis. The transthoracic echocardiography will be performed just before the transesophageal echocardiography examination using a 2- to 4-megaHertz transducer and according to standard practice guidelines. The following echocardiographic variables will be prospectively measured and calculated: left ventricle ejection fraction using Simpson method, left atrial volume will be measured using biplane method and left atrium volume index is calculated based on body surface area. Tissue Doppler images of mitral valve annulus will be measured and Pulsed wave Doppler of mitral inflow velocity.
Study does not include follow up. Study duration is up to 24 months
- Conditions
- Thrombosis of Left Atrial Appendage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transesophageal echocardiography | Patients referred for transesophageal echocardiography for a clinical indication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between left atrium volume index and Left atrial appendage flow velocity
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombosis of Left Atrial AppendageStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsayed Abo-Salem, University of Cincinnati
- Investigators
- David Harris, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500745
- Sponsor's protocol ID
- LAA velocity & LA volume
- Status last verified
- Jul 2015
- First submitted
- 2 Sep 2014
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Volume Index and Left Atrial Appendage Flow Velocities
- ClinicalTrials.gov ID
- NCT02500745
- Acronym / sponsor ID
- LAA velocity & LA volume
- Conditions
- Thrombosis of Left Atrial Appendage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 16 Jul 2015 (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.
After obtaining a consent, bed side cardiac ultrasonography will be performed for cases undergoing transesophageal echocardiography to evaluate the correlation between left atrium volume and left atrial appendage flow velocity which can predict the thrombosis risk.
Detailed description
Informed consent will be obtained prior to any research related procedures Prior to performing the transesophageal echocardiography, 4 and a 2-chamber transthoracic images will be obtained to perform standard left atrial volumetric assessment as well as speckle tracking interrogation. Both these procedures will be performed offline. The transesophageal echocardiography will be performed using available equipment with a 5- to 7-megaHertz multiplane transducer and according to standard of care. All images will be acquired per American Society of Echocardiography guidelines and will be recorded for further analysis. The left atrial appendage will be best visualized in the 60, 90 and 110 degree imaging planes and left atrial appendage contraction velocity will be recorded by placing a pulsed wave Doppler sample volume inside the proximal third of the left atrial appendage at each angle. In addition, images will be recorded using a 3-beat cycle capture to later perform offline velocity vector imaging analysis for left atrial appendage speckle tracking analysis. The transthoracic echocardiography will be performed just before the transesophageal echocardiography examination using a 2- to 4-megaHertz transducer and according to standard practice guidelines. The following echocardiographic variables will be prospectively measured and calculated: left ventricle ejection fraction using Simpson method, left atrial volume will be measured using biplane method and left atrium volume index is calculated based on body surface area. Tissue Doppler images of mitral valve annulus will be measured and Pulsed wave Doppler of mitral inflow velocity.
Study does not include follow up. Study duration is up to 24 months
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transesophageal echocardiography | – | –Patients referred for transesophageal echocardiography for a clinical indication |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for transesophageal echocardiography
Key inclusion criteria (1 listed)
- Study will include all patients 18-80 years of age and referred for transesophageal evaluation of left atrium or left atrium appendage for appropriate clinical indications, at the University of Cincinnati University Medical Center and VA Medical Center.
Key exclusion criteria (4 listed)
- Patients with either moderate to sever mitral valve disease or previous prosthetic mitral replacement.
- Patients with acute heart failure
- History of previous left atrium appendage surgical intervention.
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between left atrium volume index and Left atrial appendage flow velocity
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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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.
Elsayed Abo-salem contact
David Harris principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis of Left Atrial Appendage, run by University of Cincinnati at 1 site in United States.
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 4 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 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Contact Elsayed Abo-salem (513-558-1032), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between left atrium volume index and Left atrial appendage flow velocity (time frame: Day 1). 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 16 Jul 2015.