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Contrast Induced Acute Kidney in Patients With Acute Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03132558
Recruitment Status : Unknown
Verified November 2017 by Hai-Bin Shi, Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : April 28, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hai-Bin Shi, Nanjing Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment
Stroke, Acute Drug: Radiopaque Media

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2016
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CTA
Patients with AIS only receieved cerebral CTA exam.
Drug: Radiopaque Media
CTA+DSA
Patients with AIS receieved cerebral CTA, followed by endovascular treatment with the guidence of digital substration angiography (DSA).
Drug: Radiopaque Media



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132558


Contacts
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Contact: HaiBin Shi, MD. shihb@njmu.edu.cn

Locations
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China, Jiangsu
The First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Hai Bin Shi       shihb@njmu.edu.cn   
Principal Investigator: Haibin Shi, MD, PhD.         
Sponsors and Collaborators
Nanjing Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hai-Bin Shi, Professor, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03132558    
Other Study ID Numbers: AISAKI001
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases