About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients above 18 years of age years deemed candidates for CT angiography for pulmonary embolism by the primary team on clinical grounds and noted to be in atrial fibrillation at the time.
Room air oxygen saturation above 92%
Systolic blood pressure above 100 mm Hg
Respiratory rate less than 24 breaths/min
Disqualifiers
Inability to personally give informed consent
Pregnant or breastfeeding individuals
Stroke like symptoms
ECG criteria for ischemia or infarction
Trial design
Sequential
Treatments tested in this trial
Delayed Un-gated CT Scan for Left Atrial Appendage Thrombus
DevicePatients 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.
Delayed Gated CT Scan for Left Atrial Appendage Thrombus
DevicePatients 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
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Northwell Health
Lead sponsor
Canon Medical Systems, USA
Collaborator
This trial is not recruiting at the moment. You can still explore other options: