Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwell Health

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Delayed Un-gated CT Scan ArmExperimental treatment 1 intervention
Group B: Delayed Gated CT Scan ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Secondary outcomes

1

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.

Time frame
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.

Other outcomes

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: