Stroke, AcuteNCT03132558
Contrast Induced Acute Kidney in Patients With Acute Stroke
An observational study of Stroke, Acute, run by Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Radiopaque Media
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All patients who are suspected with AIS.
- Non-contrast head CT excludes intracranial hemorrhage.
Who cannot join
- Lacking of pre-CTA Creatinine
- Lacking of post-angiography Creatinine with 24-48 hours
Trial locations and contacts
1 site in 1 country.
HaiBin Shi, MD. contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210009
Hai Bin Shi, shihb@njmu.edu.cn
Haibin Shi, MD, PhD.
About this study
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.
- Conditions
- Stroke, Acute
- Being tested
- Radiopaque Media
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiopaque MediaDrug
| Study group | Role | What they receive |
|---|---|---|
| CTA | Patients with AIS only receieved cerebral CTA exam. Receives: Drug: Radiopaque Media | |
| CTA+DSA | Patients with AIS receieved cerebral CTA, followed by endovascular treatment with the guidence of digital substration angiography (DSA). Receives: Drug: Radiopaque Media |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 24h to 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study startSep 2016
- Primary completionSep 2017
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai-Bin Shi, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132558
- Sponsor's protocol ID
- AISAKI001
- Status last verified
- Nov 2017
- First submitted
- 25 Apr 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30679214
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Induced Acute Kidney in Patients With Acute Stroke
- ClinicalTrials.gov ID
- NCT03132558
- Acronym / sponsor ID
- AISAKI001
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTA | – | Drug: Radiopaque MediaPatients with AIS only receieved cerebral CTA exam. |
| CTA+DSA | – | Drug: Radiopaque MediaPatients with AIS receieved cerebral CTA, followed by endovascular treatment with the guidence of digital substration angiography (DSA). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- All patients who are suspected with AIS.
- Non-contrast head CT excludes intracranial hemorrhage.
Key exclusion criteria (2 listed)
- Lacking of pre-CTA Creatinine
- Lacking of post-angiography Creatinine with 24-48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiopaque Media | Drug | CTA, CTA+DSA |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Derived from this study: PubMed 30679214Jia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HaiBin Shi, MD. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HaiBin Shi, MD. (shihb@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatinine (time frame: within 24h to 48h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03132558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017; AzTrials last refreshed its copy on 6 Nov 2026.