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| Name | Class |
|---|---|
| Canon Medical Systems, USA | INDUSTRY |
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This study aims to investigate whether a quick, additional CT scan of the heart, performed immediately after a standard CT scan for pulmonary embolism, can effectively detect blood clots in the left atrial appendage (LAA) in patients with atrial fibrillation. Detecting these clots is crucial before certain heart procedures to prevent stroke. Currently, a different, more involved procedure (Transesophageal Echocardiography - TEE) is often used. This study will assess if this additional CT scan is feasible, meaning if it can provide clear enough images to identify LAA clots without needing more contrast dye. The study will involve 60 patients, half receiving an "ungated" CT scan and the other half a "gated" CT scan (timed with their heart rhythm). The results of these scans will not be used for immediate patient care during the study, but rather to evaluate the CT scan technique itself. There is no direct benefit to participants, but the information gained could lead to faster diagnosis and reduced unnecessary testing for future patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed Un-gated CT Scan Arm | Experimental | This arm will include the first 30 patients, who will undergo a 60-second delayed, un-gated CT scan to assess the left atrial appendage. |
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| Delayed Gated CT Scan Arm | Experimental | This arm will include the subsequent 30 patients, who will undergo a 60-second delayed, gated CT scan to assess the left atrial appendage. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delayed Un-gated CT Scan for Left Atrial Appendage Thrombus | Device | Patients already undergoing CT angiography for suspected pulmonary embolism will receive an additional, delayed un-gated CT scan (60 seconds after initial contrast injection) to assess for LAA clot. No additional intravenous contrast will be given. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Indeterminate Left Atrial Appendage (LAA) Thrombus Scans | The primary endpoint of this study is to test the hypothesis that less than or equal to 20% of the repeat CT scan (described above) will be indeterminate for the presence or absence of left atrial appendage thrombus. Additionally, the proportion of indeterminate gated CT scans will be compared to the proportion of indeterminate ungated CT scans. | The overall assessment and statistical analysis of this primary outcome for feasibility determination will be conducted at the study completion, an average of one year. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of Repeat CT Scan for Left Atrial Appendage (LAA) Thrombus Detection. | The secondary outcome of this study will be calculation of the negative and positive predictive value of this additional CT scan for detection of left atrial appendage thrombus, in the study population. | The secondary outcome will only be calculated at the end of the study (expected date of one year from the first enrollment) if statistically appropriate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33161849 | Background | Senadeera SC, Palmer DG, Keenan R, Beharry J, Yuh Lim J, Hurrell MA, Mouthaan P, Fink JN, Wilson D, Lim A, Wu TY. Left Atrial Appendage Thrombus Detected During Hyperacute Stroke Imaging Is Associated With Atrial Fibrillation. Stroke. 2020 Dec;51(12):3760-3764. doi: 10.1161/STROKEAHA.120.030258. Epub 2020 Nov 9. | |
| 29622180 | Background |
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This is a non-randomized, sequential group assignment.
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| Delayed Gated CT Scan for Left Atrial Appendage Thrombus | Device | Patients already undergoing CT angiography for suspected pulmonary embolism will receive an additional, delayed gated CT scan (60 seconds after initial contrast injection) to assess for LAA clot. No additional intravenous contrast will be given. |
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| Pathan F, Hecht H, Narula J, Marwick TH. Roles of Transesophageal Echocardiography and Cardiac Computed Tomography for Evaluation of Left Atrial Thrombus and Associated Pathology: A Review and Critical Analysis. JACC Cardiovasc Imaging. 2018 Apr;11(4):616-627. doi: 10.1016/j.jcmg.2017.12.019. |
| 26930405 | Background | Ng AC, Adikari D, Yuan D, Lau JK, Yong AS, Chow V, Kritharides L. The Prevalence and Incidence of Atrial Fibrillation in Patients with Acute Pulmonary Embolism. PLoS One. 2016 Mar 1;11(3):e0150448. doi: 10.1371/journal.pone.0150448. eCollection 2016. |
| 23682043 | Background | Shinkins B, Thompson M, Mallett S, Perera R. Diagnostic accuracy studies: how to report and analyse inconclusive test results. BMJ. 2013 May 16;346:f2778. doi: 10.1136/bmj.f2778. No abstract available. |
| 33216141 | Background | Wang RC, Miglioretti DL, Marlow EC, Kwan ML, Theis MK, Bowles EJA, Greenlee RT, Rahm AK, Stout NK, Weinmann S, Smith-Bindman R. Trends in Imaging for Suspected Pulmonary Embolism Across US Health Care Systems, 2004 to 2016. JAMA Netw Open. 2020 Nov 2;3(11):e2026930. doi: 10.1001/jamanetworkopen.2020.26930. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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