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Evaluating contrast enhanced ECG-gated cardiac CT (CCT) as an alternative to transesophageal echocardiography (TEE) to expedite cardioversion of atrial fibrillation (AF), improve patient care and reduce hospital admissions for AF and atrial flutter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEE arm | Active Comparator | TEE will be performed as per clinical routine using multiple standard tomographic planes to rule-out LA/LAA thrombus. Echocardiographic analysis will include: LAA-emptying velocity, and grading the severity of LAA spontaneous ECHO. The severity of the SEC will be graded on a 4 point scale with 1 = minor homogeneous contrast enhancement, 2 = significant homogeneous contrast enhancement, 3 = significant, dense, and inhomogeneous, slow-moving contrast, and 4 = dense slow-moving contrast. |
|
| CCT arm | Experimental | As per local protocol, a non-contrast enhanced prospective ECG-triggered image acquisition will be acquired. This will be followed by a contrast-enhanced prospective ECG-triggered will be acquired using a tri-phasic contrast protocols. Delayed CT images will be acquired 60 seconds after the initial contrast-enhanced CT scan.Cardiac CT image interpretation will be performed as per clinical routine. The LA and LAA will be assess for filling defects and characterized based upon attenuation values. If LA/LAA thrombus cannot be excluded, filling defects will be assessed on the delay images. Increases in attenuation would be consistent with pseudo-thrombus from 'slow flow' and 'incomplete opacification'. Areas where attenuation does not change significantly (persistent filling defect) will be diagnosed as thrombus. It will be recommended that patients with thrombus will undergo TEE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast enhanced ECG-gated cardiac CT (CCT) | Diagnostic Test | Contrast enhanced ECG-gated cardiac CT (CCT) is a sensitive, noninvasive alternative method used to exclude of left atrial and LAA thrombus. CCT provides high spatial and good temporal resolution and its ability to detect thrombus has been evaluated. CCT, compared to TEE, for the exclusion of thrombus in the LAA had a sensitivity and specificity of 100% and 99.3%, respectively. A high sensitivity is needed to minimize risk of embolus, and if a thrombus is detected on CT, a confirmatory TEE may be performed or patients may receive anticoagulation. Some argue that the potential benefits of CT and its lower associated procedural risk, the risk:benefit ratio would still favour CT. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Imaging | This outcome was measured by calculating the time between admission and imaging. | From admission to imaging/spontaneous cardioversion, up to approximately 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cardioversion | This outcome was measured by calculating the time between admission and cardioversion. | From admission to cardioversion, up to approximately 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hospital Discharge | This outcome was measured by calculating the time between admission and hospital discharge. | From admission to hospital discharge, up to approximately 90 days. |
| QoL | This outcome was calculated from the following QoLs: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) and Atrial Fibrillation Impact (AFImpact). EQ-5D-5L health score is a continuous scale from 0 to 100 with 100 being the best outcome. AFImpact scores were calculated using a seven-point Likert Scale (1=none of the time, 7=all of the time). AFImpact-Vitality, Emotional Distress, Sleep score (AFImpact-VEDS) was calculated using all questions in the questionnaire. The difference between AFImpact-VEDS scores at hospital admission and discharge was calculated where minimum change in score is 0 and maximum change in score is 108. AFImpact-emotional distress subscale score was calculated using 8 questions about emotional distress. The difference between AFImpact emotional distress scores at hospital admission and discharge was calculated where minimum change in score is 0 and maximum change in score is 48. The higher change in AFImpact scores represented a better outcome. |
Inclusion Criteria:
Exclusion Criteria:
Indication for acute cardioversion (e.g. hemodynamic instability, acute coronary syndrome (ACS), or pulmonary edema)
Unwillingness or inability to provide informed consent
Contraindication to Cardiac CT
Contraindication to TEE
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Chow, MD | UOHI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
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Total of 102 participants, 52 were randomized to CCT and 50 to TEE
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| ID | Title | Description |
|---|---|---|
| FG000 | TEE Arm | TEE will be performed as per clinical routine using multiple standard tomographic planes to rule-out LA/LAA thrombus. Echocardiographic analysis will include: LAA-emptying velocity, and grading the severity of LAA spontaneous ECHO. The severity of the SEC will be graded on a 4 point scale with 1 = minor homogeneous contrast enhancement, 2 = significant homogeneous contrast enhancement, 3 = significant, dense, and inhomogeneous, slow-moving contrast, and 4 = dense slow-moving contrast. Transesophageal Echocardiography (TEE): TEE is considered the reference standard to rule-out left atrial (LA) and left atrial appendage (LAA) thrombus prior to cardioversion. Several studies have examined the accuracy of TEE for detecting LAA thrombus. Compared to autopsy and intraoperative findings, TEE has a mean sensitivity of 100% and mean specificity of 99%. Although the gold standard, a TEE-guided therapy is still associated with an embolic rate of 0.8%. |
| FG001 | CCT Arm | A non-contrast enhanced prospective ECG-triggered image acquisition will be acquired. This will be followed by a contrast-enhanced prospective ECG-triggered will be acquired using tri-phasic contrast protocols. Delayed CT images will be acquired 60 seconds after initial contrast-enhanced CT scan.Cardiac CT image interpretation will be performed as per clinical routine. The LA and LAA will be assess for filling defects and characterized based upon attenuation values. If LA/LAA thrombus cannot be excluded, filling defects will be assessed on the delay images. Increases in attenuation would be consistent with pseudo-thrombus from 'slow flow' and 'incomplete opacification'. Areas where attenuation does not change significantly (persistent filling defect) will be diagnosed as thrombus. It will be recommended that patients with thrombus will undergo TEE. Contrast enhanced ECG-gated cardiac CT (CCT): Contrast enhanced ECG-gated cardiac CT (CCT) is a sensitive, noninvasive alternative method used to exclude left atrial and LAA thrombus. CCT provides high spatial and good temporal resolution and its ability to detect thrombus has been evaluated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TEE Arm | TEE will be performed as per clinical routine using multiple standard tomographic planes to rule-out LA/LAA thrombus. Echocardiographic analysis will include: LAA-emptying velocity, and grading the severity of LAA spontaneous ECHO. The severity of the SEC will be graded on a 4 point scale with 1 = minor homogeneous contrast enhancement, 2 = significant homogeneous contrast enhancement, 3 = significant, dense, and inhomogeneous, slow-moving contrast, and 4 = dense slow-moving contrast. Transesophageal Echocardiography (TEE): TEE is considered the reference standard to rule-out left atrial (LA) and left atrial appendage (LAA) thrombus prior to cardioversion. Several studies have examined the accuracy of TEE for detecting LAA thrombus. Compared to autopsy and intraoperative findings, TEE has a mean sensitivity of 100% and mean specificity of 99%. Although the gold standard, a TEE-guided therapy is still associated with an embolic rate of 0.8%. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Imaging | This outcome was measured by calculating the time between admission and imaging. | Posted | Mean | Standard Deviation | hours | From admission to imaging/spontaneous cardioversion, up to approximately 30 days. |
|
Adverse event data was collected for 1 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TEE Arm | TEE will be performed as per clinical routine using multiple standard tomographic planes to rule-out LA/LAA thrombus. Echocardiographic analysis will include: LAA-emptying velocity, and grading the severity of LAA spontaneous ECHO. The severity of the SEC will be graded on a 4 point scale with 1 = minor homogeneous contrast enhancement, 2 = significant homogeneous contrast enhancement, 3 = significant, dense, and inhomogeneous, slow-moving contrast, and 4 = dense slow-moving contrast. Transesophageal Echocardiography (TEE): TEE is considered the reference standard to rule-out left atrial (LA) and left atrial appendage (LAA) thrombus prior to cardioversion. Several studies have examined the accuracy of TEE for detecting LAA thrombus. Compared to autopsy and intraoperative findings, TEE has a mean sensitivity of 100% and mean specificity of 99%. Although the gold standard, a TEE-guided therapy is still associated with an embolic rate of 0.8%. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal impairment | Renal and urinary disorders | Systematic Assessment | 25% increase in baseline creatinine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Chow | University of Ottawa Heart Institute | 6136966786 | bchow@ottawaheart.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2020 | Sep 17, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 14, 2019 | Apr 15, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017548 | Echocardiography, Transesophageal |
| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Transesophageal Echocardiography (TEE) | Diagnostic Test | TEE is considered the reference standard to rule-out left atrial (LA) and left atrial appendage (LAA) thrombus prior to cardioversion. Several studies have examined the accuracy of TEE for detecting LAA thrombus. Compared to autopsy and intraoperative findings, TEE has a mean sensitivity of 100% and mean specificity of 99%. Although the gold standard, a TEE-guided therapy is still associated with an embolic rate of 0.8%. |
|
| At hospital discharge |
| BG001 | CCT Arm | A non-contrast enhanced prospective ECG-triggered image acquisition will be acquired. This will be followed by a contrast-enhanced prospective ECG-triggered will be acquired using tri-phasic contrast protocols. Delayed CT images will be acquired 60 seconds after initial contrast-enhanced CT scan.Cardiac CT image interpretation will be performed as per clinical routine. The LA and LAA will be assess for filling defects and characterized based upon attenuation values. If LA/LAA thrombus cannot be excluded, filling defects will be assessed on the delay images. Increases in attenuation would be consistent with pseudo-thrombus from 'slow flow' and 'incomplete opacification'. Areas where attenuation does not change significantly (persistent filling defect) will be diagnosed as thrombus. It will be recommended that patients with thrombus will undergo TEE. Contrast enhanced ECG-gated cardiac CT (CCT): Contrast enhanced ECG-gated cardiac CT (CCT) is a sensitive, noninvasive alternative method used to exclude left atrial and LAA thrombus. CCT provides high spatial and good temporal resolution and its ability to detect thrombus has been evaluated. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | CCT Arm | A non-contrast enhanced prospective ECG-triggered image acquisition will be acquired. This will be followed by a contrast-enhanced prospective ECG-triggered will be acquired using tri-phasic contrast protocols. Delayed CT images will be acquired 60 seconds after initial contrast-enhanced CT scan.Cardiac CT image interpretation will be performed as per clinical routine. The LA and LAA will be assess for filling defects and characterized based upon attenuation values. If LA/LAA thrombus cannot be excluded, filling defects will be assessed on the delay images. Increases in attenuation would be consistent with pseudo-thrombus from 'slow flow' and 'incomplete opacification'. Areas where attenuation does not change significantly (persistent filling defect) will be diagnosed as thrombus. It will be recommended that patients with thrombus will undergo TEE. Contrast enhanced ECG-gated cardiac CT (CCT): Contrast enhanced ECG-gated cardiac CT (CCT) is a sensitive, noninvasive alternative method used to exclude left atrial and LAA thrombus. CCT provides high spatial and good temporal resolution and its ability to detect thrombus has been evaluated. |
|
|
| Secondary | Time to Cardioversion | This outcome was measured by calculating the time between admission and cardioversion. | Posted | Mean | Standard Deviation | days | From admission to cardioversion, up to approximately 30 days |
|
|
|
| Other Pre-specified | Time to Hospital Discharge | This outcome was measured by calculating the time between admission and hospital discharge. | Posted | Mean | Standard Deviation | days | From admission to hospital discharge, up to approximately 90 days. |
|
|
|
| Other Pre-specified | QoL | This outcome was calculated from the following QoLs: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) and Atrial Fibrillation Impact (AFImpact). EQ-5D-5L health score is a continuous scale from 0 to 100 with 100 being the best outcome. AFImpact scores were calculated using a seven-point Likert Scale (1=none of the time, 7=all of the time). AFImpact-Vitality, Emotional Distress, Sleep score (AFImpact-VEDS) was calculated using all questions in the questionnaire. The difference between AFImpact-VEDS scores at hospital admission and discharge was calculated where minimum change in score is 0 and maximum change in score is 108. AFImpact-emotional distress subscale score was calculated using 8 questions about emotional distress. The difference between AFImpact emotional distress scores at hospital admission and discharge was calculated where minimum change in score is 0 and maximum change in score is 48. The higher change in AFImpact scores represented a better outcome. | Posted | Mean | Standard Deviation | score | At hospital discharge |
|
|
|
| 1 |
| 50 |
| 0 |
| 50 |
| 14 |
| 50 |
| EG001 | CCT Arm | A non-contrast enhanced prospective ECG-triggered image acquisition will be acquired. This will be followed by a contrast-enhanced prospective ECG-triggered will be acquired using tri-phasic contrast protocols. Delayed CT images will be acquired 60 seconds after initial contrast-enhanced CT scan.Cardiac CT image interpretation will be performed as per clinical routine. The LA and LAA will be assess for filling defects and characterized based upon attenuation values. If LA/LAA thrombus cannot be excluded, filling defects will be assessed on the delay images. Increases in attenuation would be consistent with pseudo-thrombus from 'slow flow' and 'incomplete opacification'. Areas where attenuation does not change significantly (persistent filling defect) will be diagnosed as thrombus. It will be recommended that patients with thrombus will undergo TEE. Contrast enhanced ECG-gated cardiac CT (CCT): Contrast enhanced ECG-gated cardiac CT (CCT) is a sensitive, noninvasive alternative method used to exclude left atrial and LAA thrombus. CCT provides high spatial and good temporal resolution and its ability to detect thrombus has been evaluated. | 1 | 52 | 0 | 52 | 17 | 52 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| Atrial Fibrillation Impact (AFImpact)-emotional distress |
|