Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study
Part of paid clinical trials in Manhasset, New York.
- Sponsor
- Northwell Health
- Study ID
- NCT07647939
- Status
- Not Yet Recruiting
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Conditions
- Atrial Fibrillation (AF)
- Left Atrial Appendage Thrombosis
- Pulmonary Embolism (PE)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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.
Study Details
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.
Key Dates
- Start date
- Jul 31, 2026
- Status verified
- Jun 2026
- Primary completion
- Apr 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Delayed Un-gated CT Scan ArmThis arm will include the first 30 patients, who will undergo a 60-second delayed, un-gated CT scan to assess the left atrial appendage.
- Experimental: Delayed Gated CT Scan ArmThis arm will include the subsequent 30 patients, who will undergo a 60-second delayed, gated CT scan to assess the left atrial appendage.
Primary Outcome Measure
Percentage of Indeterminate Left Atrial Appendage (LAA) Thrombus 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. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11030 | Ana Centeno Rahbani Ramanak Mitra, MD (PRINCIPAL_INVESTIGATOR) |
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