Acute Ischaemic StrokeSENTRYNCT07321275
Ultra-early Chest CT for SAP Prediction
An observational study of Acute Ischaemic Stroke and Stroke-associated Pneumonia, run by Capital Medical University at 8 sites in China.
Trial summary
Stroke-associated pneumonia (SAP) is a common and serious complication after acute ischaemic stroke (AIS). Existing scores rely mainly on clinical variables, and the added prognostic value of inflammatory markers and early chest CT findings remains uncertain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischaemic Stroke, Stroke-associated Pneumonia
- How many people
- 1,499 participants
- Where
- 8 sitesChina
- Study dates
- 15 Jan 2026to 19 Feb 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥18 years) with neuroimaging-confirmed acute ischemic stroke admitted to participating tertiary stroke centers in China. Eligibility requires chest CT performed within 24 h of stroke onset . Patients will be retrospectively identified from electronic medical records and stroke registries, and stroke-associated pneumonia will be assessed within 7 days after stroke onset using prespecified criteria. Only the first eligible admission per individual will be included.
Who may be able to join
- patients aged ≥18 years;
- Admitted to a participating stroke centre with neuroimaging-confirmed acute ischaemic stroke ;
- Had chest CT performed within 24 hours of stroke onset.
Who cannot join
- Pneumonia;
- Chest CT images unavailable or incomplete for assessment;
- Insufficient clinical documentation to ascertain stroke-associated pneumonia occurrence within 7 days after stroke onset
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Rongcheng County People's Hospital
Baoding, Hebei
Xuanwu Hospita
Beijing
Ningjin County People's Hospital
Fenghuang, Hebei, 055550
Shihezi People's Hospital,
Shihezi, Xinjiang, 836800
The Second Hospital of Hebei Medical University,
Shijiazhuang, Hebei, 050061
Suzhou Municipal Hospital of Anhui Province
Suzhou, Anhui, 234000
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Central Hospital of Xiangtan
Xiangtan, Hunan, 411100
About this study
Official title: Ultra-early Chest CT Improves Risk Prediction of Stroke-associated Pneumonia: Model Development and External Validation in a Multicentre Retrospective Study
Stroke-associated pneumonia (SAP) is a common and serious complication after acute ischaemic stroke (AIS). Existing scores rely mainly on clinical variables, and the added prognostic value of inflammatory markers and early chest CT findings remains uncertain. We developed and externally validated an early multimodal model combining clinical severity, inflammation, and chest CT abnormalities, and explored risk-stratified associations between prophylactic antibiotics and SAP.
- Keywords
- Acute ischaemic stroke, Stroke-associated pneumonia, Risk prediction model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Development (Derivation) cohort | Not described | |
| External validation cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke-associated pneumonia
SAP was defined as pneumonia occurring within 7 days after stroke onset. Potential events were screened using discharge diagnosis codes and medical record documentation, and then confirmed by manual chart review using prespecified clinical, laboratory, and radiological criteria consistent with the Pneumonia in Stroke Consensus Group and modified CDC definitions.
Measured: within 7 days after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Jan 2026
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischaemic StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321275
- Sponsor's protocol ID
- SENTRY
- Acronym
- SENTRY
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-early Chest CT Improves Risk Prediction of Stroke-associated Pneumonia: Model Development and External Validation in a Multicentre Retrospective Study
- ClinicalTrials.gov ID
- NCT07321275
- Acronym / sponsor ID
- SENTRY / SENTRY
- Keywords
- Acute ischaemic stroke, Stroke-associated pneumonia, Risk prediction model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,499 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 7 Jan 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.
Stroke-associated pneumonia (SAP) is a common and serious complication after acute ischaemic stroke (AIS). Existing scores rely mainly on clinical variables, and the added prognostic value of inflammatory markers and early chest CT findings remains uncertain. We developed and externally validated an early multimodal model combining clinical severity, inflammation, and chest CT abnormalities, and explored risk-stratified associations between prophylactic antibiotics and SAP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Development (Derivation) cohort | – | – |
| External validation cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years) with neuroimaging-confirmed acute ischemic stroke admitted to participating tertiary stroke centers in China. Eligibility requires chest CT performed within 24 h of stroke onset . Patients will be retrospectively identified from electronic medical records and stroke registries, and stroke-associated pneumonia will be assessed within 7 days after stroke onset using prespecified criteria. Only the first eligible admission per individual will be included.
Key inclusion criteria (3 listed)
- patients aged ≥18 years;
- Admitted to a participating stroke centre with neuroimaging-confirmed acute ischaemic stroke ;
- Had chest CT performed within 24 hours of stroke onset.
Key exclusion criteria (3 listed)
- Pneumonia;
- Chest CT images unavailable or incomplete for assessment;
- Insufficient clinical documentation to ascertain stroke-associated pneumonia occurrence within 7 days after stroke onset
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stroke-associated pneumonia
Time frame: within 7 days after stroke onset
SAP was defined as pneumonia occurring within 7 days after stroke onset. Potential events were screened using discharge diagnosis codes and medical record documentation, and then confirmed by manual chart review using prespecified clinical, laboratory, and radiological criteria consistent with the Pneumonia in Stroke Consensus Group and modified CDC definitions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Yes. Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischaemic Stroke and Stroke-associated Pneumonia, run by Capital Medical University at 8 sites in China.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke-associated pneumonia (time frame: within 7 days after stroke onset). 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 10 Mar 2026.