A Multicenter Prospective Observational Study of Acute Ischemic Stroke in Patients With Active Cancer (CAT-AIS)
Clinical Characteristics and Stroke Recurrence in Patients With Acute Ischemic Stroke and Active Cancer: CAT-AIS Study
The goal of this multicenter prospective observational study, conducted at 24 hospitals in Japan, is to learn about recurrent ischemic stroke in people with active cancer who develop acute ischemic stroke. One of the main objectives is to evaluate how often ischemic stroke recurs during follow-up.
The main questions this study aims to answer are:
- How often does ischemic stroke recur within 3 months after the initial stroke?
- Which clinical factors may be associated with recurrent ischemic stroke?
- What other clinical outcomes occur during follow-up?
Participants will receive medical care determined by their treating physicians. Researchers will collect information about participants' cancer, stroke characteristics, test results, treatments, recurrent ischemic stroke, and other clinical outcomes. Researchers will also explore whether clinical factors are associated with recurrent ischemic stroke and other outcomes. This study will not assign participants to a specific treatment.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Osaka
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Suita, Osaka, Japan, 565-0871
- Recruiting
- The Univeristy of Osaka
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Contact:
- Yasufumi Gon, MD, PhD
- Phone Number: +81-6-6879-5111
- Email: gon@neurol.med.osaka-u.ac.jp
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Acute ischemic stroke diagnosed within 7 days after symptom onset or the time last known well.
- Active cancer at the time of the index stroke, as defined below.
Exclusion Criteria:
- The patient or a legally acceptable representative indicates that the patient does not wish to participate.
- The investigator considers enrolment inappropriate.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Participants with acute ischemic stroke and active cancer
Participants with active cancer who develop acute ischemic stroke and are enrolled prospectively at participating hospitals.
Clinical information, treatments, recurrent ischemic stroke, and other outcomes will be collected during follow-up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants With Recurrent Ischemic Stroke Within 3 Months
Time Frame: From enrollment through 3 months of follow-up
|
The percentage of participants who experience recurrent ischemic stroke during follow-up.
Recurrent ischemic stroke will be determined according to the criteria prespecified in the study protocol.
|
From enrollment through 3 months of follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25379
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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