Left Atrial Appendage ThrombiNCT00797576
Detection of Left Atrial Appendage (LAA) Thrombus: Comparison of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram
An observational study of Left Atrial Appendage Thrombi, run by Gundersen Lutheran Medical Foundation at 1 site in United States.
Trial summary
The purpose of this study is to compare Cardiac Magnetic Resonance (CMR) Imaging with transesophageal echocardiography (TEE) in detecting the presence of LAA thrombi in men and women with atrial fibrillation presenting for cardioversion. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Left Atrial Appendage Thrombi
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study cases will consist of subjects referred for TEE prior to cardioversion who are found to have LAA thrombus present. Control subjects will be patients referred for TEE with chronic atrial fibrillation that will not be undergoing cardioversion. All subjects will be patients from our facility, Gundersen Lutheran Health System, La Crosse, WI.
Who may be able to join
- atrial fibrillation
Who cannot join
- ICDs
- pacemakers
- intracranial clips
- intracranial stimulator devices
- insulin pumps
- intra ocular metal foreign bodies
Show all 9Show fewer
- cochlear implants
- LAA amputation as part of CABG and/or valve surgery
- GFR < 60 mL/min
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Gundersen Lutheran Health System
La Crosse, Wisconsin, 54601
Vicki L McHugh, MS, 608-775-3857, vlmchugh@gundluth.org
Kara J Kallies, BA, 608-775-2904, kjkallie@gundluth.org
About this study
Official title: Detection of Left Atrial Appendage Thrombus in Patients Referred For Cardioversion: Comparative Analysis of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram
The purpose of this study is to compare Cardiac Magnetic Resonance (CMR) Imaging with transesophageal echocardiography (TEE) in detecting the presence of LAA thrombi in men and women with atrial fibrillation presenting for cardioversion.
Read the detailed description
The identification of left atrial appendage (LAA) thrombus prior to cardioversion for patients with atrial fibrillation is crucial. LAA thrombus can be a frequent cause of cerebral stroke or peripheral embolism post cardioversion, and anticoagulation therapy is required in these instances to prevent cerebral events and avoid embolization. To date, TEE has been considered the clinical reference in detection of LAA thrombi with high diagnostic accuracy. However, diagnosis and size estimation of LAA thrombi remains challenging due to the complex anatomy of the LAA, and transesophageal echocardiography (TEE) is considered a semi-invasive procedure. To date, there have been few comparative studies involving TEE and cardiac magnetic resonance (CMR) imaging, and the results have been conflicting. With newer CMR Imaging techniques now available, we hypothesize that comparable results will be achieved in detecting LAA thrombus in subjects using a less invasive procedure.
- Conditions
- Left Atrial Appendage Thrombi
- Keywords
- left atrial appendage thrombi, transesophageal echocardiogram, cardiac magnetic resonance imaging, atrial fibrillation, cardioversion
- Medical subject headings
- Atrial Fibrillation
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 |
|---|---|---|
| 1/Cases | Subjects whom had cardioversion aborted due to LAA thrombus or suspicion of LAA thrombus on TEE. | |
| 2/Controls | Subjects with underlying atrial fibrillation undergoing elective TEE as clinically indicated for any reason. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy values for CMR Imaging for detection of LAA thrombus. (sensitivity, specificity, negative predictive value, and positive predictive value)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Left Atrial Appendage ThrombiStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gundersen Lutheran Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Gundersen Lutheran Health System
- Investigators
- Raju G Ailiani, MD, Principal investigator, Gundersen Lutheran Health SystemVicki L McHugh, MS, Study director, Gundersen Lutheran Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797576
- Sponsor's protocol ID
- 2-07-05-001
- Status last verified
- Aug 2009
- First submitted
- 24 Nov 2008
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Bjerkelund CJ, Orning OM. The efficacy of anticoagulant therapy in preventing embolism related to D.C. electrical conversion of atrial fibrillation. Am J Cardiol. 1969 Feb;23(2):208-16. doi: 10.1016/0002-9149(69)90068-x. No abstract available.
PubMed 4180019Henry WL, Morganroth J, Pearlman AS, Clark CE, Redwood DR, Itscoitz SB, Epstein SE. Relation between echocardiographically determined left atrial size and atrial fibrillation. Circulation. 1976 Feb;53(2):273-9. doi: 10.1161/01.cir.53.2.273.
PubMed 128423Stein B, Halperin JL, Fuster V. Should patients with atrial fibrillation be anticoagulated prior to and chronically following cardioversion? Cardiovasc Clin. 1990;21(1):231-47; discussion 248-9. No abstract available.
PubMed 2199050Paydarfar D, Krieger D, Dib N, Blair RH, Pastore JO, Stetz JJ Jr, Symes JF. In vivo magnetic resonance imaging and surgical histopathology of intracardiac masses: distinct features of subacute thrombi. Cardiology. 2001;95(1):40-7. doi: 10.1159/000047342.
PubMed 11385191Barkhausen J, Hunold P, Eggebrecht H, Schuler WO, Sabin GV, Erbel R, Debatin JF. Detection and characterization of intracardiac thrombi on MR imaging. AJR Am J Roentgenol. 2002 Dec;179(6):1539-44. doi: 10.2214/ajr.179.6.1791539.
PubMed 12438051Ohyama H, Mizushige K, Hosomi N. Magnetic resonance imaging of left atrial thrombus. Heart. 2002 Sep;88(3):233. doi: 10.1136/heart.88.3.233. No abstract available.
PubMed 12181211Ohyama H, Hosomi N, Takahashi T, Mizushige K, Osaka K, Kohno M, Koziol JA. Comparison of magnetic resonance imaging and transesophageal echocardiography in detection of thrombus in the left atrial appendage. Stroke. 2003 Oct;34(10):2436-9. doi: 10.1161/01.STR.0000090350.73614.0F. Epub 2003 Sep 11.
PubMed 12970519Mohrs OK, Nowak B, Petersen SE, Welsner M, Rubel C, Magedanz A, Kauczor HU, Voigtlaender T. Thrombus detection in the left atrial appendage using contrast-enhanced MRI: a pilot study. AJR Am J Roentgenol. 2006 Jan;186(1):198-205. doi: 10.2214/AJR.04.1504.
PubMed 16357402Saksena S, Sra JS, Jordaens L, et al. Intracardiac Echocardiography-Guided Cardioversion Helps Interventional Procedures (ICE-CHIP) trial. Heart Rhythm Society 2007 Scientific Sessions; May 11, 2007; Denver, CO. Late Breaking clinical Trials II.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Left Atrial Appendage Thrombus in Patients Referred For Cardioversion: Comparative Analysis of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram
- ClinicalTrials.gov ID
- NCT00797576
- Acronym / sponsor ID
- 2-07-05-001
- Conditions
- Left Atrial Appendage Thrombi
- Keywords
- left atrial appendage thrombi, transesophageal echocardiogram, cardiac magnetic resonance imaging, atrial fibrillation, cardioversion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Gundersen Lutheran Medical FoundationUniversity, hospital or other
- Collaborators
- Gundersen Lutheran Health System
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 25 Nov 2008 (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.
The purpose of this study is to compare Cardiac Magnetic Resonance (CMR) Imaging with transesophageal echocardiography (TEE) in detecting the presence of LAA thrombi in men and women with atrial fibrillation presenting for cardioversion.
Detailed description
The identification of left atrial appendage (LAA) thrombus prior to cardioversion for patients with atrial fibrillation is crucial. LAA thrombus can be a frequent cause of cerebral stroke or peripheral embolism post cardioversion, and anticoagulation therapy is required in these instances to prevent cerebral events and avoid embolization. To date, TEE has been considered the clinical reference in detection of LAA thrombi with high diagnostic accuracy. However, diagnosis and size estimation of LAA thrombi remains challenging due to the complex anatomy of the LAA, and transesophageal echocardiography (TEE) is considered a semi-invasive procedure. To date, there have been few comparative studies involving TEE and cardiac magnetic resonance (CMR) imaging, and the results have been conflicting. With newer CMR Imaging techniques now available, we hypothesize that comparable results will be achieved in detecting LAA thrombus in subjects using a less invasive procedure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/Cases | – | –Subjects whom had cardioversion aborted due to LAA thrombus or suspicion of LAA thrombus on TEE. |
| 2/Controls | – | –Subjects with underlying atrial fibrillation undergoing elective TEE as clinically indicated for any reason. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study cases will consist of subjects referred for TEE prior to cardioversion who are found to have LAA thrombus present. Control subjects will be patients referred for TEE with chronic atrial fibrillation that will not be undergoing cardioversion. All subjects will be patients from our facility, Gundersen Lutheran Health System, La Crosse, WI.
Key inclusion criteria (1 listed)
- atrial fibrillation
Key exclusion criteria (9 listed)
- ICDs
- pacemakers
- intracranial clips
- intracranial stimulator devices
- insulin pumps
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
Accuracy values for CMR Imaging for detection of LAA thrombus. (sensitivity, specificity, negative predictive value, and positive predictive value)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
- Background: PubMed 4180019Bjerkelund CJ, Orning OM. The efficacy of anticoagulant therapy in preventing embolism related to D.C. electrical conversion of atrial fibrillation. Am J Cardiol. 1969 Feb;23(2):208-16. doi: 10.1016/0002-9149(69)90068-x. No abstract available.
- Background: PubMed 128423Henry WL, Morganroth J, Pearlman AS, Clark CE, Redwood DR, Itscoitz SB, Epstein SE. Relation between echocardiographically determined left atrial size and atrial fibrillation. Circulation. 1976 Feb;53(2):273-9. doi: 10.1161/01.cir.53.2.273.
- Background: PubMed 2199050Stein B, Halperin JL, Fuster V. Should patients with atrial fibrillation be anticoagulated prior to and chronically following cardioversion? Cardiovasc Clin. 1990;21(1):231-47; discussion 248-9. No abstract available.
- Background: PubMed 11385191Paydarfar D, Krieger D, Dib N, Blair RH, Pastore JO, Stetz JJ Jr, Symes JF. In vivo magnetic resonance imaging and surgical histopathology of intracardiac masses: distinct features of subacute thrombi. Cardiology. 2001;95(1):40-7. doi: 10.1159/000047342.
- Background: PubMed 12438051Barkhausen J, Hunold P, Eggebrecht H, Schuler WO, Sabin GV, Erbel R, Debatin JF. Detection and characterization of intracardiac thrombi on MR imaging. AJR Am J Roentgenol. 2002 Dec;179(6):1539-44. doi: 10.2214/ajr.179.6.1791539.
- Background: PubMed 12181211Ohyama H, Mizushige K, Hosomi N. Magnetic resonance imaging of left atrial thrombus. Heart. 2002 Sep;88(3):233. doi: 10.1136/heart.88.3.233. No abstract available.
- Background: PubMed 12970519Ohyama H, Hosomi N, Takahashi T, Mizushige K, Osaka K, Kohno M, Koziol JA. Comparison of magnetic resonance imaging and transesophageal echocardiography in detection of thrombus in the left atrial appendage. Stroke. 2003 Oct;34(10):2436-9. doi: 10.1161/01.STR.0000090350.73614.0F. Epub 2003 Sep 11.
- Background: PubMed 16357402Mohrs OK, Nowak B, Petersen SE, Welsner M, Rubel C, Magedanz A, Kauczor HU, Voigtlaender T. Thrombus detection in the left atrial appendage using contrast-enhanced MRI: a pilot study. AJR Am J Roentgenol. 2006 Jan;186(1):198-205. doi: 10.2214/AJR.04.1504.
- BackgroundSaksena S, Sra JS, Jordaens L, et al. Intracardiac Echocardiography-Guided Cardioversion Helps Interventional Procedures (ICE-CHIP) trial. Heart Rhythm Society 2007 Scientific Sessions; May 11, 2007; Denver, CO. Late Breaking clinical Trials II.
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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.
Raju G Ailiani, MD principal investigator
Gundersen Lutheran Health System
Vicki L McHugh, MS study director
Gundersen Lutheran Medical Foundation
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 Left Atrial Appendage Thrombi, run by Gundersen Lutheran Medical Foundation 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 9 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 22 Jun 2010. 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 Raju G Ailiani, MD (608-775-2595, rgailian@gundluth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy values for CMR Imaging for detection of LAA thrombus. (sensitivity, specificity, negative predictive value, and positive predictive value) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00797576, which also lists 9 linked publications.
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 22 Jun 2010.