Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, stroke, TEE, Left atrial thrombus
Brief summary
The investigators intend to determine if using Optison echocardiography contrast increases sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal echocardiography studies as opposed to standard 2D and 3D TEE imaging without the use of echo contrast.
Detailed description
Accurate determination of the presence or absence of left atrial appendage (LAA) thrombus has a large impact on the clinical course of patients with atrial fibrillation or ischemic stroke and has large financial implications as well. Misdiagnosing the presence of LAA thrombus can lead to unnecessarily cancelled procedures (cardioversion and atrial fibrillation ablation) and potentially hazardous, unnecessary changes in clinical care (such as prolonged Coumadin anticoagulation). Missing LAA thrombus can result in continuation of cardioversion or atrial fibrillation ablation procedures at a time when there is higher risk of subsequent embolic stroke. Several of the patients with atrial fibrillation require transesophageal echocardiography (TEE) performed prior to cardioversion or atrial fibrillation ablation procedures. There is opportunity to enroll most of these patients in our proposed study. There has been essentially no work published about the use of echo contrast materials in TEE (other than agitated saline), particularly the use of Optison. Thus, the investigators will be exploring a new field in echocardiography and echo contrast.
Interventions
DRUGOptison echocardiography contrast agent
Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* \> 18 years old * Cognitively sound and able to provide informed consent * Indicated for TEE as a standard clinical procedure for evaluation of cardiac health status.
Exclusion criteria
* Contraindicated for Optison administration * Known right-to-left or bi-directional cardiac shunts * Hypersensitivity to perflutren, blood, blood products or albumen * Women who are pregnant * Removal of Left Atrial Appendage * Not able to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Confidence in Assessment of Left Atrial Appendage Thrombus | One Transesophageal Echocardiography, up to 1 hour | Confidence among echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent. Percent confidence was calculated from a subjective assessment made by each reader after viewing the echo images. A six-point scale was used by the readers to grade the subjective assessment of their confidence in detecting thrombus; a score of 0 representing 0% (no confidence) up to a score of 5 representing 100% (total confidence) that the interpretation was correct for presence or absence of left atrial appendage thrombus. The reported percent confidence is the average of both echo readers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage | One transesophageal echocardiography, up to 1 hour | Percent agreement between echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Echo Arm Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent
Optison echocardiography contrast agent: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Echo Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 70 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 69.9 years STANDARD_DEVIATION 11.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 95 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 1 / 100 |
Outcome results
Primary
Percent Confidence in Assessment of Left Atrial Appendage Thrombus
Confidence among echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent. Percent confidence was calculated from a subjective assessment made by each reader after viewing the echo images. A six-point scale was used by the readers to grade the subjective assessment of their confidence in detecting thrombus; a score of 0 representing 0% (no confidence) up to a score of 5 representing 100% (total confidence) that the interpretation was correct for presence or absence of left atrial appendage thrombus. The reported percent confidence is the average of both echo readers.
Time frame: One Transesophageal Echocardiography, up to 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-Contrast | Percent Confidence in Assessment of Left Atrial Appendage Thrombus | 55 Percentage of Confidence | Standard Deviation 12.5 |
| Post-Contrast | Percent Confidence in Assessment of Left Atrial Appendage Thrombus | 95 Percentage of Confidence | Standard Deviation 7.5 |
p-value: <0.001Chi-squared
Secondary
Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage
Percent agreement between echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent
Time frame: One transesophageal echocardiography, up to 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-Contrast | Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage | 72 Percentage of Agreement |
| Post-Contrast | Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage | 96 Percentage of Agreement |
p-value: <0.001Chi-squared