Acute StrokeNCT03510312
Long-term Prognosis in Stroke Patients
An observational study of Acute Stroke, run by Severance Hospital at 1 site in South Korea.
Trial summary
A single-center cohort of patients with acute ischemic stroke and transient ischemic attack who admitted to the Severance hospital of Yonsei university and their long-term outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Stroke
- How many people
- 9,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Dec 2021
- How long will I take part?
- 10 Years
- 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 with acute ischemic stroke/transient ischemic attack
Who may be able to join
- All patients with acute ischemic stroke or transient ischemic attack
Who cannot join
- A patient who did not agree with enrollment of this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ji Hoe Heo
Seoul
Ji Hoe Heo, MD, PhD, 82-2-2228-1605, jhheo@yuhs.ac
About this study
A single-center cohort of patients with acute ischemic stroke and transient ischemic attack who admitted to the Severance hospital of Yonsei university and their long-term outcomes.
Read the detailed description
This is a single-center cohort of consecutive patients with acute ischemic stroke and transient ischemic attack who admitted to the Severance hospital of Yonsei university in Republic of Korea.
Stroke recurrence, Cardiovascular event, all cause mortality and cardiovascular mortality were collected through long-term follow up.
- Conditions
- Acute Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Long-term follow up, observational | This cohort does not involve interventions, just follow up of prognosis of ischemic stroke/transient ischemic attack patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event of Stroke or transient ischemic attack
The time of a stroke or transient ischemic attack occurs (through study completion)
Measured: through study completion, up to 10 years
Event of cardiovascular disease (include stroke/transient ischemic attack)
The time of a cardiovascular disease (stroke/transient ischemic attack) occurs (through study completion)
Measured: through study completion, up to 10 years
All cause mortality
The time of death from any cause (through study completion)
Measured: through study completion, up to 10 years
Cardiovascular cause mortality (include stroke/transient ischemic attack mortality)
The time of death from cardiovascular cause (through study completion)
Measured: through study completion, up to 10 years
The modified Rankin Scale (mRS)
Measure functional outcome as the form of mRS at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study startDec 2011
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- 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
- 9,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hoe Heo, Severance Hospital
- Investigators
- Ji Hoe Heo, MD, PhD, Study chair, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510312
- Sponsor's protocol ID
- 4-2011-0731
- Status last verified
- Mar 2021
- First submitted
- 28 Dec 2016
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Prognosis in Stroke Patients
- ClinicalTrials.gov ID
- NCT03510312
- Acronym / sponsor ID
- 4-2011-0731
- Conditions
- Acute Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 27 Apr 2018 (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.
A single-center cohort of patients with acute ischemic stroke and transient ischemic attack who admitted to the Severance hospital of Yonsei university and their long-term outcomes.
Detailed description
This is a single-center cohort of consecutive patients with acute ischemic stroke and transient ischemic attack who admitted to the Severance hospital of Yonsei university in Republic of Korea.
Stroke recurrence, Cardiovascular event, all cause mortality and cardiovascular mortality were collected through long-term follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-term follow up, observational | – | –This cohort does not involve interventions, just follow up of prognosis of ischemic stroke/transient ischemic attack patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with acute ischemic stroke/transient ischemic attack
Key inclusion criteria (1 listed)
- All patients with acute ischemic stroke or transient ischemic attack
Key exclusion criteria (1 listed)
- A patient who did not agree with enrollment of this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Event of Stroke or transient ischemic attack
Time frame: through study completion, up to 10 years
The time of a stroke or transient ischemic attack occurs (through study completion)
Event of cardiovascular disease (include stroke/transient ischemic attack)
Time frame: through study completion, up to 10 years
The time of a cardiovascular disease (stroke/transient ischemic attack) occurs (through study completion)
All cause mortality
Time frame: through study completion, up to 10 years
The time of death from any cause (through study completion)
Cardiovascular cause mortality (include stroke/transient ischemic attack mortality)
Time frame: through study completion, up to 10 years
The time of death from cardiovascular cause (through study completion)
The modified Rankin Scale (mRS)
Time frame: 3 months
Measure functional outcome as the form of mRS at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
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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.
Ji Hoe Heo, MD, PhD study chair
Yonsei University
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 Acute Stroke, run by Severance Hospital at 1 site in South Korea.
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 1 inclusion and 1 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 24 Mar 2021. 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 South Korea. 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 Ji Hoe Heo, MD, PhD (82-2-2228-1605, jhheo@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event of Stroke or transient ischemic attack (time frame: through study completion, up to 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2021.