Aneurysm, DissectingNCT05017896
Prediction of Acute Kidney Injury After Operation of Acute Type A Aortic Dissection Based on Multimodal Model
An observational study of Aneurysm, Dissecting and Acute Kidney Injury, run by Qilu Hospital of Shandong University.
Trial summary
Acute kidney injury is one of the most common postoperative complications of acute type A aortic dissection, which is closely related to early postoperative death. Early prevention, early diagnosis and early treatment are the key to improve the prognosis of such patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Aneurysm, Dissecting, Acute Kidney Injury
- What is being tested?
- Normal CT Renal Perfusion imaging indexes and Low CT Renal Perfusion imaging indexes
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Feb 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients sufferred acute type A aortic dissection.
Who may be able to join
- 18-70 years old
- Acute type A aortic dissection diagnosed by CT angiography
- Sign informed consent
Who cannot join
- History of chronic kidney disease
- History of cardiovascular operation
- Acute kidney injury has occurred before operation
- Pregnancy status
Trial locations and contacts
No sites are listed yet.
About this study
Acute kidney injury is one of the most common postoperative complications of acute type A aortic dissection, which is closely related to early postoperative death. Early prevention, early diagnosis and early treatment are the key to improve the prognosis of such patients. It has been a hot topic in clinical research for a long time. Previous reports revealed a series of risk factors for acute kidney injury after aortic dissection, but limited by research design and single modal data, high quality studies were rare. The purpose of this study is to further clarify the risk factors by studying the relationship between preoperative CT renal perfusion imaging indexes and postoperative acute kidney injury; establish and externally verify the multimodal radiomics prediction model for acute kidney injury after operation of aortic dissection combining with preoperative CT renal perfusion imaging and CT angiography information by analysis methods of information fusion, feature engineering and radiomics, so as to guide the follow-up clinical practice, improve the prognosis of such patients and save medical resources.
- Conditions
- Aneurysm, Dissecting, Acute Kidney Injury
- Being tested
- Normal CT Renal Perfusion imaging indexes, Low CT Renal Perfusion imaging indexes
- Medical subject headings
- Aortic Dissection, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal CT Renal Perfusion imaging indexesDiagnostic test
A CT imaging which indicates the status of renal perfusion is normal.
Low CT Renal Perfusion imaging indexesDiagnostic test
A CT imaging which indicates the status of renal perfusion is low.
| Study group | Role | What they receive |
|---|---|---|
| Normal Perfusion | Not described Receives: Diagnostic Test: Normal CT Renal Perfusion imaging indexes | |
| Low Perfusion | Not described Receives: Diagnostic Test: Low CT Renal Perfusion imaging indexes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury after operation
Yes; No
Measured: From date of operation until the date of acute kidney injury or date of death from any cause, whichever came first, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm, DissectingStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Prospective
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Zhao, Principal investigator, Department of cardiac surgery, Qilu Hospital, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017896
- Sponsor's protocol ID
- 2020SDUCRCC031
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Acute Kidney Injury After Operation of Acute Type A Aortic Dissection Based on Multimodal Model
- ClinicalTrials.gov ID
- NCT05017896
- Acronym / sponsor ID
- 2020SDUCRCC031
- Conditions
- Aneurysm, Dissecting, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 24 Aug 2021 (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.
Acute kidney injury is one of the most common postoperative complications of acute type A aortic dissection, which is closely related to early postoperative death. Early prevention, early diagnosis and early treatment are the key to improve the prognosis of such patients. It has been a hot topic in clinical research for a long time. Previous reports revealed a series of risk factors for acute kidney injury after aortic dissection, but limited by research design and single modal data, high quality studies were rare. The purpose of this study is to further clarify the risk factors by studying the relationship between preoperative CT renal perfusion imaging indexes and postoperative acute kidney injury; establish and externally verify the multimodal radiomics prediction model for acute kidney injury after operation of aortic dissection combining with preoperative CT renal perfusion imaging and CT angiography information by analysis methods of information fusion, feature engineering and radiomics, so as to guide the follow-up clinical practice, improve the prognosis of such patients and save medical resources.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Perfusion | – | Diagnostic Test: Normal CT Renal Perfusion imaging indexes |
| Low Perfusion | – | Diagnostic Test: Low CT Renal Perfusion imaging indexes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients sufferred acute type A aortic dissection.
Key inclusion criteria (3 listed)
- 18-70 years old
- Acute type A aortic dissection diagnosed by CT angiography
- Sign informed consent
Key exclusion criteria (4 listed)
- History of chronic kidney disease
- History of cardiovascular operation
- Acute kidney injury has occurred before operation
- Pregnancy 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 |
|---|---|---|
| Normal CT Renal Perfusion imaging indexesA CT imaging which indicates the status of renal perfusion is normal. | Diagnostic test | Normal Perfusion |
| Low CT Renal Perfusion imaging indexesA CT imaging which indicates the status of renal perfusion is low. | Diagnostic test | Low Perfusion |
Primary outcome
Acute kidney injury after operation
Time frame: From date of operation until the date of acute kidney injury or date of death from any cause, whichever came first, assessed up to 30 days.
Yes; No
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Xin Zhao principal investigator
Department of cardiac surgery, Qilu Hospital, Shandong University
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm, Dissecting and Acute Kidney Injury, run by Qilu Hospital of Shandong University.
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 4 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 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Xin Zhao (+8618560086772, zhaoxin3617@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury after operation (time frame: From date of operation until the date of acute kidney injury or date of death from any cause, whichever came first, assessed up to 30 days.). 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 24 Aug 2021.