- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03132558
Contrast Induced Acute Kidney in Patients With Acute Stroke
November 4, 2017 updated by: Hai-Bin Shi, Nanjing Medical University
Computed tomographic angiography (CTA) is recommended for identifying eligible patient with acute ischemic stroke (AIS) to receieve endovascular treatment.
We are going to conduct this prospective corhot study to observe if sequential use contrast in CTA examination and in endovascular treatment will cause acute kidney injury.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Recruiting
- The First Affiliated Hospital of Nanjing Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients who are suspected with AIS.
Non-contrast head CT excludes intracranial hemorrhage.
Patients who receieve CTA or CTA+DSA will be included in this study.
Description
Inclusion Criteria:
- All patients who are suspected with AIS.
- Non-contrast head CT excludes intracranial hemorrhage.
Exclusion Criteria:
- Lacking of pre-CTA Creatinine
- Lacking of post-angiography Creatinine with 24-48 hours
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
CTA
Patients with AIS only receieved cerebral CTA exam.
|
|
|
CTA+DSA
Patients with AIS receieved cerebral CTA, followed by endovascular treatment with the guidence of digital substration angiography (DSA).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Creatinine
Time Frame: within 24h to 48h
|
Contrast-induced acute kidney injury was defined as a relative increase of 25% or an absolute increase of 0.3 mg/dL (28.2mol/L) in the serum creatinine level at 48 hours following angiography
|
within 24h to 48h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
September 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
April 25, 2017
First Submitted That Met QC Criteria
April 25, 2017
First Posted (Actual)
April 28, 2017
Study Record Updates
Last Update Posted (Actual)
November 7, 2017
Last Update Submitted That Met QC Criteria
November 4, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AISAKI001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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