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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05017896
Other study ID # 2020SDUCRCC031
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2021
Est. completion date February 2023

Study information

Verified date August 2021
Source Qilu Hospital of Shandong University
Contact Xin Zhao
Phone +8618560086772
Email zhaoxin3617@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 242
Est. completion date February 2023
Est. primary completion date January 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. 18-70 years old 2. Acute type A aortic dissection diagnosed by CT angiography 3. Sign informed consent Exclusion Criteria: 1. History of chronic kidney disease 2. History of cardiovascular operation 3. Acute kidney injury has occurred before operation 4. Pregnancy status

Study Design


Intervention

Diagnostic Test:
Normal CT Renal Perfusion imaging indexes
A CT imaging which indicates the status of renal perfusion is normal.
Low CT Renal Perfusion imaging indexes
A CT imaging which indicates the status of renal perfusion is low.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Outcome

Type Measure Description Time frame Safety issue
Primary Acute kidney injury after operation Yes; No 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.
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