NCT05017896

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

August 17, 2021

Last Update Submit

August 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Normal Perfusion

Diagnostic Test: Normal CT Renal Perfusion imaging indexes

Low Perfusion

Diagnostic Test: Low CT Renal Perfusion imaging indexes

Interventions

A CT imaging which indicates the status of renal perfusion is normal.

Normal Perfusion

A CT imaging which indicates the status of renal perfusion is low.

Low Perfusion

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients sufferred acute type A aortic dissection.

You may qualify if:

  • years old
  • Acute type A aortic dissection diagnosed by CT angiography
  • Sign informed consent

You may not qualify if:

  • History of chronic kidney disease
  • History of cardiovascular operation
  • Acute kidney injury has occurred before operation
  • Pregnancy status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic DissectionAcute Kidney Injury

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Xin Zhao

    Department of cardiac surgery, Qilu Hospital, Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2021

First Posted

August 24, 2021

Study Start

September 1, 2021

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

August 24, 2021

Record last verified: 2021-08