DyspneaCT-DysNCT06104475
Diagnostic Performance of Chest Computed Tomography Scan in Patients Aged 65 and Over Presenting to Emergency Room With Acute Dyspnea
A study testing CT scan in people with Dyspnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In acute dyspnea, the use of chest radiography is frequent and not very contributive, especially in the elderly patients. However, early diagnosis of the cause of dyspnea in the ED is associated with a better prognosis, in particular for the identification of an infectious or cardiac origin. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2023to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age greater than or equal to 65 years
- Acute dyspnea (< 1 week)
- Prescription of a chest x-ray
- Oral free and informed consent of the patient after information and delivery of the information note
- Patient affiliated to a social security system
Who cannot join
- Inability to lie down
- Chest imaging done within the last 7 days
- Indication to perform a thoracic scan
- Patient under guardianship or curatorship
- Patient deprived of liberty, pregnant woman
- Participation in other interventional research
Trial locations and contacts
1 site in 1 country.
About this study
In acute dyspnea, the use of chest radiography is frequent and not very contributive, especially in the elderly patients.
However, early diagnosis of the cause of dyspnea in the ED is associated with a better prognosis, in particular for the identification of an infectious or cardiac origin.
Read more
Chest CT has already shown better diagnostic performances than conventional radiography in several pathologies such as low respiratory infection, and the development of so-called "low dose" scans allows to limit the irradiation during this examination.
The investigators aim to conduct a diagnostic study comparing non-injected chest CT-scan and conventional chest radiography in patients older than 65 presenting in the ED with acute dyspnea to assess whether CT-scan improves diagnosis.
Read the detailed description
Patients of 65 years and older presenting to the emergency department with acute dyspnea and for whom a chest radiography is mandatory will be screened for inclusion. If the inclusion criteria are met and in the absence of non-inclusion criteria, free and informed oral consent will be sought.
Once the patient is included, management by the emergency physician will be routine.
A non-injected chest CT scan will be requested to the emergency radiology department in addition to the chest radiography. As a result, an X-ray and then a CT scan will be performed in each patient.
3 diagnoses will be collected:
- By the emergency physician in charge of the patient, after the chest X-ray and before the CT scan (DiagU1)
- By the emergency physician in charge of the patient, after the results of the scan (DiagU2)
- By an adjudication committee after review of the medical file (DiagExpert) A comparison will be made between the 3 diagnoses.
- Conditions
- Dyspnea
- Being tested
- CT scan
- Keywords
- Dyspnea, ED, Chest CT-scan
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanOther
A CT scan will be requested for every patient in addition to the chest X-ray
| Study group | Role | What they receive |
|---|---|---|
| CT scan intervention | Experimental | Not described Receives: Other: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved diagnosis
Proportion of patients with "bad diagnosis" before scanning and "good diagnosis" after scanning (according to adjudication committee)
Measured: 28 days after inclusion
Secondary outcomes (3)
Discordant diagnosis
Proportion of patients with discordant pre- and post-scan diagnoses
Measured: 28 days after inclusion
Improvement in diagnostic certainty
Difference in "Diagnostic certainty" in percentage by self-assessment before and after scan
Measured: 28 days after inclusion
Scans performed
Proportion of patients for whom the scan was actually performed
Measured: baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study startDec 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yonathan FREUND, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104475
- Sponsor's protocol ID
- APHP220845
- Acronym
- CT-Dys
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Chest Computed Tomography Scan in Patients Aged 65 and Over Presenting to Emergency Room With Acute Dyspnea
- ClinicalTrials.gov ID
- NCT06104475
- Acronym / sponsor ID
- CT-Dys / APHP220845
- Conditions
- Dyspnea
- Keywords
- Dyspnea, ED, Chest CT-scan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 27 Oct 2023 (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.
In acute dyspnea, the use of chest radiography is frequent and not very contributive, especially in the elderly patients.
However, early diagnosis of the cause of dyspnea in the ED is associated with a better prognosis, in particular for the identification of an infectious or cardiac origin.
Chest CT has already shown better diagnostic performances than conventional radiography in several pathologies such as low respiratory infection, and the development of so-called "low dose" scans allows to limit the irradiation during this examination.
The investigators aim to conduct a diagnostic study comparing non-injected chest CT-scan and conventional chest radiography in patients older than 65 presenting in the ED with acute dyspnea to assess whether CT-scan improves diagnosis.
Detailed description
Patients of 65 years and older presenting to the emergency department with acute dyspnea and for whom a chest radiography is mandatory will be screened for inclusion. If the inclusion criteria are met and in the absence of non-inclusion criteria, free and informed oral consent will be sought.
Once the patient is included, management by the emergency physician will be routine.
A non-injected chest CT scan will be requested to the emergency radiology department in addition to the chest radiography. As a result, an X-ray and then a CT scan will be performed in each patient.
3 diagnoses will be collected:
- By the emergency physician in charge of the patient, after the chest X-ray and before the CT scan (DiagU1)
- By the emergency physician in charge of the patient, after the results of the scan (DiagU2)
- By an adjudication committee after review of the medical file (DiagExpert) A comparison will be made between the 3 diagnoses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT scan intervention | Experimental | Other: CT scan |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age greater than or equal to 65 years
- Acute dyspnea (< 1 week)
- Prescription of a chest x-ray
- Oral free and informed consent of the patient after information and delivery of the information note
- Patient affiliated to a social security system
Key exclusion criteria (6 listed)
- Inability to lie down
- Chest imaging done within the last 7 days
- Indication to perform a thoracic scan
- Patient under guardianship or curatorship
- Patient deprived of liberty, pregnant woman
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 |
|---|---|---|
| CT scanA CT scan will be requested for every patient in addition to the chest X-ray | Other | CT scan intervention |
Primary outcome
Improved diagnosis
Time frame: 28 days after inclusion
Proportion of patients with "bad diagnosis" before scanning and "good diagnosis" after scanning (according to adjudication committee)
3 secondary outcomes
Discordant diagnosis
Time frame: 28 days after inclusion
Improvement in diagnostic certainty
Time frame: 28 days after inclusion
Scans performed
Time frame: baseline (Day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yonathan FREUND, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan in people with Dyspnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 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: status not confirmed, as of the sponsor's last update on 27 Oct 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonathan FREUND, PU-PH (00 33 1 84 82 71 29, yonathan.freund@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved diagnosis (time frame: 28 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2023.