NCT03132558

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

April 25, 2017

Last Update Submit

November 4, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Creatinine

    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

Study Arms (2)

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

Interventions

CTACTA+DSA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patients who are suspected with AIS.
  • Non-contrast head CT excludes intracranial hemorrhage.

You may not qualify if:

  • Lacking of pre-CTA Creatinine
  • Lacking of post-angiography Creatinine with 24-48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210009, China

RECRUITING

Related Publications (1)

  • Jia ZY, Wang SX, Zhao LB, Cao YZ, Shi HB, Liu S. Risk of Acute Kidney Injury with Consecutive, Multidose Use of Iodinated Contrast in Patients with Acute Ischemic Stroke. AJNR Am J Neuroradiol. 2019 Apr;40(4):652-654. doi: 10.3174/ajnr.A5959. Epub 2019 Jan 24.

MeSH Terms

Conditions

Stroke

Interventions

Contrast Media

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Central Study Contacts

HaiBin Shi, MD.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 25, 2017

First Posted

April 28, 2017

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

November 7, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations