Pulmonary Embolism (Diagnosis)NCT07905781
Clinical Management and Outcomes After Lung Scintigraphy for Suspected Pulmonary Embolism in the Emergency Department
An observational study of Pulmonary Embolism (Diagnosis), run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study will review the medical records of adults evaluated for a suspected blood clot in the lungs (pulmonary embolism) in the emergency department at Antalya Training and Research Hospital. It will include patients who underwent a lung perfusion scan, which shows blood flow in the lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism (Diagnosis)
- What is being tested?
- Pulmonary Perfusion Scintigraphy
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2026to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or older who presented to the emergency department of Antalya Training and Research Hospital with suspected pulmonary embolism and underwent pulmonary perfusion scintigraphy, with or without additional ventilation scintigraphy, between January 1, 2019, and September 4, 2026. All eligible patients within this period will be identified retrospectively from hospital records. Approximately 100 patients are expected to be included.
Who may be able to join
- Age 18 years or older at the index emergency department visit.
- Evaluation for suspected pulmonary embolism at Antalya Training and Research Hospital during the study period.
- Completion of pulmonary perfusion scintigraphy, with or without additional ventilation scintigraphy, for suspected pulmonary embolism.
- Availability of medical records containing the demographic, clinical, imaging, and outcome information required for the study.
Who cannot join
- Scintigraphy performed for an indication other than suspected pulmonary embolism.
- Scintigraphy requested by a department other than the emergency department.
- Scintigraphy requested but not completed.
- Unavailable scintigraphy reports or essential clinical records.
- Unavailable essential outcome information, including emergency department disposition, hospitalization, intensive care admission, or mortality status.
- Duplicate records relating to the same clinical episode. Separate episodes involving a new evaluation for suspected pulmonary embolism may be included as distinct clinical episodes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences, Antalya Training and Research Hospital
Antalya, konyaaltı, 21090
murat Duyan, ASSOCIATE PROFESSOR, +905401561989, drmuratduyan@gmail.com
About this study
Official title: Evaluation of the Impact of Scintigraphy on Clinical Decision-Making and Patient Outcomes in Patients Undergoing Pulmonary Perfusion Scintigraphy and, When Required, Ventilation/Perfusion Scintigraphy for Suspected Pulmonary Embolism in the Emergency Department
This study will review the medical records of adults evaluated for a suspected blood clot in the lungs (pulmonary embolism) in the emergency department at Antalya Training and Research Hospital. It will include patients who underwent a lung perfusion scan, which shows blood flow in the lungs. Some patients also underwent a ventilation scan, which shows airflow in the lungs.
The main aim is to assess how scan findings were related to clinical decisions, including starting or stopping blood-thinning treatment, requesting additional imaging, and admitting patients to hospital or discharging them. The study will also examine time spent in the emergency department and hospital, intensive care admission, return visits to the emergency department, and deaths within 30 days.
Researchers will compare patients who had a perfusion scan alone with those who also had a ventilation scan. All tests and treatments were provided as part of routine care. The study will use existing records only; patients will not undergo additional tests, receive study treatments, or be contacted for research.
Read the detailed description
This single-center, retrospective observational cohort study will use routinely collected electronic health records from Antalya Training and Research Hospital. The historical review period begins on January 1, 2019, and extends to the ethics committee approval date. All eligible records within this period will be screened without random sampling.
Data sources will include emergency department records, nuclear medicine reports, laboratory results, radiology reports, and discharge summaries. Extracted variables will include presenting symptoms, comorbidities, risk factors for venous thromboembolism, vital signs, renal function, pregnancy status, contrast allergy, and available laboratory and imaging findings.
In routine practice at the study center, pulmonary perfusion scintigraphy is performed first. Ventilation scintigraphy is added when the perfusion findings require further clarification or when considered necessary by the nuclear medicine team. Imaging selection is determined by clinical care rather than the research protocol. Scan findings will be classified according to the original nuclear medicine reports as normal or low probability, high probability or suggestive of pulmonary embolism, or intermediate probability or nondiagnostic.
Clinical management before and after the scan report will be reviewed where documented. Management changes will be assessed using recorded diagnostic assessments, anticoagulation decisions, requests for additional imaging, and disposition decisions. A decision occurring after scintigraphy will not, by timing alone, be considered evidence that the scan changed management; attribution will depend on the available clinical documentation. Subsequent outcomes will be ascertained from existing records without additional patient contact.
Duplicate records from the same clinical episode will be excluded. Missing information and the availability of follow-up records will be documented. Absence of a recorded return visit or death will be distinguished from confirmed absence of the event.
Analyses will describe patient characteristics, scan findings, management decisions, and outcomes. Comparisons will be performed by imaging pathway and scan-result category using appropriate methods for categorical and continuous variables. Regression analyses may be used to examine associations with management changes and clinical outcomes, depending on the available sample size and number of events. Comparisons between imaging pathways will be interpreted with consideration of differences in clinical indications and baseline characteristics.
Data will be de-identified before analysis. No additional imaging, treatment, laboratory testing, or biological sample collection will be performed for research purposes.
- Conditions
- Pulmonary Embolism (Diagnosis)
- Being tested
- Pulmonary Perfusion Scintigraphy
- Keywords
- Suspected Pulmonary Embolism, Pulmonary Perfusion Scintigraphy, Ventilation/Perfusion Scintigraphy, Emergency Department, Clinical Decision-Making, Patient Outcomes
- Medical subject headings
- Pulmonary Embolism, Disease, Respiratory Aspiration, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Perfusion ScintigraphyDiagnostic test
Pulmonary perfusion scintigraphy performed during routine clinical care to evaluate suspected pulmonary embolism. Findings will be extracted retrospectively from existing nuclear medicine reports. No additional imaging will be performed for research purposes.
| Study group | Role | What they receive |
|---|---|---|
| Perfusion Scintigraphy Only | Adults evaluated for suspected pulmonary embolism in the emergency department who underwent pulmonary perfusion scintigraphy without additional ventilation scintigraphy during routine clinical care. Clinical characteristics, imaging findings, management decisions, and patient outcomes will be assessed retrospectively from existing medical records. Receives: Diagnostic Test: Pulmonary Perfusion Scintigraphy | |
| Perfusion Scintigraphy With Additional Ventilation Scintigraphy | Adults evaluated for suspected pulmonary embolism in the emergency department who underwent pulmonary perfusion scintigraphy followed by additional ventilation scintigraphy during routine clinical care. Clinical characteristics, imaging findings, management decisions, and patient outcomes will be assessed retrospectively from existing medical records. Receives: Diagnostic Test: Pulmonary Perfusion Scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With a Documented Clinical Management Change Related to Scintigraphy Findings
Percentage of patients with at least one documented change related to scintigraphy findings in the diagnostic assessment of pulmonary embolism, initiation or discontinuation of anticoagulation, requests for additional imaging, or admission or discharge plans. Changes will be identified by retrospectively comparing documented assessments and plans before and after the scintigraphy report. A decision occurring after scintigraphy without evidence of a change in the documented plan will not be classified as a management change.
Measured: Within 24 hours after the scintigraphy report becomes available.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start10 Oct 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Embolism (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905781
- Sponsor's protocol ID
- 2026/425
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared because the dataset contains potentially sensitive clinical information obtained retrospectively from hospital records. Only aggregate results will be reported to protect patient privacy and confidentiality.
Publications
Waxman AD, Bajc M, Brown M, Fahey FH, Freeman LM, Haramati LB, Julien P, Le Gal G, Neilly B, Rabin J, Soudry G, Tapson V, Torbati S, Kauffman J, Ahuja S, Donohoe K. Appropriate Use Criteria for Ventilation-Perfusion Imaging in Pulmonary Embolism: Summary and Excerpts. J Nucl Med. 2017 May;58(5):13N-15N. No abstract available.
PubMed 28461589Bajc M, Schumichen C, Gruning T, Lindqvist A, Le Roux PY, Alatri A, Bauer RW, Dilic M, Neilly B, Verberne HJ, Delgado Bolton RC, Jonson B. EANM guideline for ventilation/perfusion single-photon emission computed tomography (SPECT) for diagnosis of pulmonary embolism and beyond. Eur J Nucl Med Mol Imaging. 2019 Nov;46(12):2429-2451. doi: 10.1007/s00259-019-04450-0. Epub 2019 Aug 13.
PubMed 31410539
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Scintigraphy on Clinical Decision-Making and Patient Outcomes in Patients Undergoing Pulmonary Perfusion Scintigraphy and, When Required, Ventilation/Perfusion Scintigraphy for Suspected Pulmonary Embolism in the Emergency Department
- ClinicalTrials.gov ID
- NCT07905781
- Acronym / sponsor ID
- 2026/425
- Conditions
- Pulmonary Embolism (Diagnosis)
- Keywords
- Suspected Pulmonary Embolism, Pulmonary Perfusion Scintigraphy, Ventilation/Perfusion Scintigraphy, Emergency Department, Clinical Decision-Making, Patient Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Antalya Health Sciences UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will review the medical records of adults evaluated for a suspected blood clot in the lungs (pulmonary embolism) in the emergency department at Antalya Training and Research Hospital. It will include patients who underwent a lung perfusion scan, which shows blood flow in the lungs. Some patients also underwent a ventilation scan, which shows airflow in the lungs.
The main aim is to assess how scan findings were related to clinical decisions, including starting or stopping blood-thinning treatment, requesting additional imaging, and admitting patients to hospital or discharging them. The study will also examine time spent in the emergency department and hospital, intensive care admission, return visits to the emergency department, and deaths within 30 days.
Researchers will compare patients who had a perfusion scan alone with those who also had a ventilation scan. All tests and treatments were provided as part of routine care. The study will use existing records only; patients will not undergo additional tests, receive study treatments, or be contacted for research.
Detailed description
This single-center, retrospective observational cohort study will use routinely collected electronic health records from Antalya Training and Research Hospital. The historical review period begins on January 1, 2019, and extends to the ethics committee approval date. All eligible records within this period will be screened without random sampling.
Data sources will include emergency department records, nuclear medicine reports, laboratory results, radiology reports, and discharge summaries. Extracted variables will include presenting symptoms, comorbidities, risk factors for venous thromboembolism, vital signs, renal function, pregnancy status, contrast allergy, and available laboratory and imaging findings.
In routine practice at the study center, pulmonary perfusion scintigraphy is performed first. Ventilation scintigraphy is added when the perfusion findings require further clarification or when considered necessary by the nuclear medicine team. Imaging selection is determined by clinical care rather than the research protocol. Scan findings will be classified according to the original nuclear medicine reports as normal or low probability, high probability or suggestive of pulmonary embolism, or intermediate probability or nondiagnostic.
Clinical management before and after the scan report will be reviewed where documented. Management changes will be assessed using recorded diagnostic assessments, anticoagulation decisions, requests for additional imaging, and disposition decisions. A decision occurring after scintigraphy will not, by timing alone, be considered evidence that the scan changed management; attribution will depend on the available clinical documentation. Subsequent outcomes will be ascertained from existing records without additional patient contact.
Duplicate records from the same clinical episode will be excluded. Missing information and the availability of follow-up records will be documented. Absence of a recorded return visit or death will be distinguished from confirmed absence of the event.
Analyses will describe patient characteristics, scan findings, management decisions, and outcomes. Comparisons will be performed by imaging pathway and scan-result category using appropriate methods for categorical and continuous variables. Regression analyses may be used to examine associations with management changes and clinical outcomes, depending on the available sample size and number of events. Comparisons between imaging pathways will be interpreted with consideration of differences in clinical indications and baseline characteristics.
Data will be de-identified before analysis. No additional imaging, treatment, laboratory testing, or biological sample collection will be performed for research purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perfusion Scintigraphy Only | – | Diagnostic Test: Pulmonary Perfusion ScintigraphyAdults evaluated for suspected pulmonary embolism in the emergency department who underwent pulmonary perfusion scintigraphy without additional ventilation scintigraphy during routine clinical care. Clinical characteristics, imaging findings, management decisions, and patient outcomes will be assessed retrospectively from existing medical records. |
| Perfusion Scintigraphy With Additional Ventilation Scintigraphy | – | Diagnostic Test: Pulmonary Perfusion ScintigraphyAdults evaluated for suspected pulmonary embolism in the emergency department who underwent pulmonary perfusion scintigraphy followed by additional ventilation scintigraphy during routine clinical care. Clinical characteristics, imaging findings, management decisions, and patient outcomes will be assessed retrospectively from existing medical records. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older who presented to the emergency department of Antalya Training and Research Hospital with suspected pulmonary embolism and underwent pulmonary perfusion scintigraphy, with or without additional ventilation scintigraphy, between January 1, 2019, and September 4, 2026. All eligible patients within this period will be identified retrospectively from hospital records. Approximately 100 patients are expected to be included.
Key inclusion criteria (4 listed)
- Age 18 years or older at the index emergency department visit.
- Evaluation for suspected pulmonary embolism at Antalya Training and Research Hospital during the study period.
- Completion of pulmonary perfusion scintigraphy, with or without additional ventilation scintigraphy, for suspected pulmonary embolism.
- Availability of medical records containing the demographic, clinical, imaging, and outcome information required for the study.
Key exclusion criteria (6 listed)
- Scintigraphy performed for an indication other than suspected pulmonary embolism.
- Scintigraphy requested by a department other than the emergency department.
- Scintigraphy requested but not completed.
- Unavailable scintigraphy reports or essential clinical records.
- Unavailable essential outcome information, including emergency department disposition, hospitalization, intensive care admission, or mortality status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Perfusion ScintigraphyPulmonary perfusion scintigraphy performed during routine clinical care to evaluate suspected pulmonary embolism. Findings will be extracted retrospectively from existing nuclear medicine reports. No additional imaging will be performed for research purposes. | Diagnostic test | Perfusion Scintigraphy Only, Perfusion Scintigraphy With Additional Ventilation Scintigraphy |
Primary outcome
Proportion of Patients With a Documented Clinical Management Change Related to Scintigraphy Findings
Time frame: Within 24 hours after the scintigraphy report becomes available.
Percentage of patients with at least one documented change related to scintigraphy findings in the diagnostic assessment of pulmonary embolism, initiation or discontinuation of anticoagulation, requests for additional imaging, or admission or discharge plans. Changes will be identified by retrospectively comparing documented assessments and plans before and after the scintigraphy report. A decision occurring after scintigraphy without evidence of a change in the documented plan will not be classified as a management change.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 28461589Waxman AD, Bajc M, Brown M, Fahey FH, Freeman LM, Haramati LB, Julien P, Le Gal G, Neilly B, Rabin J, Soudry G, Tapson V, Torbati S, Kauffman J, Ahuja S, Donohoe K. Appropriate Use Criteria for Ventilation-Perfusion Imaging in Pulmonary Embolism: Summary and Excerpts. J Nucl Med. 2017 May;58(5):13N-15N. No abstract available.
- Background: PubMed 31410539Bajc M, Schumichen C, Gruning T, Lindqvist A, Le Roux PY, Alatri A, Bauer RW, Dilic M, Neilly B, Verberne HJ, Delgado Bolton RC, Jonson B. EANM guideline for ventilation/perfusion single-photon emission computed tomography (SPECT) for diagnosis of pulmonary embolism and beyond. Eur J Nucl Med Mol Imaging. 2019 Nov;46(12):2429-2451. doi: 10.1007/s00259-019-04450-0. Epub 2019 Aug 13.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared because the dataset contains potentially sensitive clinical information obtained retrospectively from hospital records. Only aggregate results will be reported to protect patient privacy and confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism (Diagnosis), run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact murat Duyan, ASSOCIATE PROFESSOR (+905401561989, drmuratduyan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With a Documented Clinical Management Change Related to Scintigraphy Findings (time frame: Within 24 hours after the scintigraphy report becomes available.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07905781, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.