Aortic DissectionNCT05699395
Quick Recognition of Aortic Dissection
An observational study of Aortic Dissection, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This is an observational study that establishes a cohort of patients with high risk chest pain who have been identified by CTA for aortic dissection. We then used this cohort to validate the accuracy of identifying aortic dissection based on extremity oximetry and Doppler waveforms. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- Non interventional
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 May 2025
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: High risk chest pain patients
Who may be able to join
- High risk chest pain with CTA
Who cannot join
- shock
- coma
- severe peripheral vascular diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai
Jingchao Luo, MD, 13121021484, sucapter@163.com
About this study
Official title: Identification of Aortic Dissection Based on Pulse Oxygen and Ultrasound Doppler Waveforms
This is an observational study that establishes a cohort of patients with high risk chest pain who have been identified by CTA for aortic dissection. We then used this cohort to validate the accuracy of identifying aortic dissection based on extremity oximetry and Doppler waveforms.
- Conditions
- Aortic Dissection
- Being tested
- Non interventional
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionalDiagnostic test
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Aortic Dissection | Not described Receives: Diagnostic Test: Non interventional | |
| Non Aortic Dissection | Not described Receives: Diagnostic Test: Non interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of aortic dissection
aortic dissection confirmed by CTA
Measured: First 24-hours during emergency dapartment stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Dec 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699395
- Sponsor's protocol ID
- QRAD2022
- Status last verified
- Nov 2022
- First submitted
- 23 Nov 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Aortic Dissection Based on Pulse Oxygen and Ultrasound Doppler Waveforms
- ClinicalTrials.gov ID
- NCT05699395
- Acronym / sponsor ID
- QRAD2022
- Conditions
- Aortic Dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 26 Jan 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.
This is an observational study that establishes a cohort of patients with high risk chest pain who have been identified by CTA for aortic dissection. We then used this cohort to validate the accuracy of identifying aortic dissection based on extremity oximetry and Doppler waveforms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aortic Dissection | – | Diagnostic Test: Non interventional |
| Non Aortic Dissection | – | Diagnostic Test: Non interventional |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- High risk chest pain patients
Key inclusion criteria (1 listed)
- High risk chest pain with CTA
Key exclusion criteria (3 listed)
- shock
- coma
- severe peripheral vascular diseases
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 |
|---|---|---|
| Non interventionalNo intervention | Diagnostic test | Aortic Dissection, Non Aortic Dissection |
Primary outcome
Diagnosis of aortic dissection
Time frame: First 24-hours during emergency dapartment stay
aortic dissection confirmed by CTA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 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.
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 Aortic Dissection, run by Shanghai Zhongshan Hospital at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 26 Jan 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of aortic dissection (time frame: First 24-hours during emergency dapartment stay). 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 26 Jan 2023.