Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study (ELATE-AF)
9. juni 2026 oppdatert av: Northwell Health
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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New York
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Manhasset, New York, Forente stater, 11030
- North Shore University Hospital
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Ta kontakt med:
- Tabetha Garver-Mosher
- Telefonnummer: 1514 516-562-0100
- E-post: tgarvermosher@northwell.edu
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Ta kontakt med:
- Ana Centeno Rahbani
- E-post: acentenorahb@northwell.edu
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Hovedetterforsker:
- Ramanak Mitra, MD
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inability to personally give informed consent
- Pregnant or breastfeeding individuals
- Stroke like symptoms
- ECG criteria for ischemia or infarction
- Heart rate <40 or > 120 bpm (inclusive) or 3rd degree heart block
- Unable to lie flat for at least 10 minutes
- Unable to follow simple commands
- Northwell Health Employees.
- Non-English-speaking patients
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Delayed Un-gated CT Scan Arm
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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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.
|
|
Eksperimentell: Delayed Gated CT Scan Arm
This arm will include the subsequent 30 patients, who will undergo a 60-second delayed, gated CT scan to assess the left atrial appendage.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Indeterminate Left Atrial Appendage (LAA) Thrombus Scans
Tidsramme: 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.
|
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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic Accuracy of Repeat CT Scan for Left Atrial Appendage (LAA) Thrombus Detection.
Tidsramme: 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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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.
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. april 2027
Studiet fullført (Antatt)
1. juni 2027
Datoer for studieregistrering
Først innsendt
16. mars 2026
Først innsendt som oppfylte QC-kriteriene
9. juni 2026
Først lagt ut (Faktiske)
15. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 24-0413-North Shore University
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Ja
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