Embolic Stroke of Undetermined SourceNCT04455529
Current Situation of Natural History, Diagnosis and Treatment in Inpatients With Embolism Stroke of Unknown Cause (ESUS)
An observational study of Embolic Stroke of Undetermined Source, run by Peking University Third Hospital.
Trial summary
Evaluate the epidemiological characteristics, risk factors, clinical characteristics in patients with ESUS and their medication compliance and relapse within 1 year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Embolic Stroke of Undetermined Source
- What is being tested?
- ESUS
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We recruited consecutive patients with Embolism Stroke of Unknown Cause.
Who may be able to join
- Patients diagnosed with acute cerebral infarction and treated in Peking University Third Hospital Neurology Department from January 2010 to June 2016.
Who cannot join
- Lacunar infarction
- Aortic atherosclerotic cerebral infarction
- Clear cardiogenic cerebral infarction
- Other related system diseases (arteritis, vascular dissection, migraine and vasospasm, etc.)
About this study
Official title: A Research of Current Situation of Natural History, Diagnosis and Treatment in Inpatients With Embolism Stroke of Unknown Cause (ESUS)
Evaluate the epidemiological characteristics, risk factors, clinical characteristics in patients with ESUS and their medication compliance and relapse within 1 year.
Read the detailed description
The purpose of this study is to evaluate the epidemiological characteristics, risk factors (such as hypertension, diabetes, hyperlipidemia, coronary heart disease, history of previous stroke, smoking, and alcohol consumption), clinical characteristics in patients with ESUS and their medication compliance and relapse within 1 year.
- Conditions
- Embolic Stroke of Undetermined Source
- Being tested
- ESUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESUSOther
Embolic stroke of undetermined source (ESUS) designates patients with nonlacunar cryptogenic ischemic strokes in whom embolism is the likely stroke mechanism.
| Study group | Role | What they receive |
|---|---|---|
| ESUS | Embolic stroke of undetermined source (ESUS) designates patients with nonlacunar cryptogenic ischemic strokes in whom embolism is the likely stroke mechanism. Receives: Other: ESUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Medication adherence usually refers to whether patients take their medications as prescribed (eg, twice daily), as well as whether they continue to take a prescribed medication. The Morisky scale, a validated, 4-item self-reported adherence measure that has been shown to be predictive of adherence to cardiovascular medications and blood pressure control. If a patient scores higher on the scale, they are evaluated as more adherent. If they score lower on the scale, they are presumed to be struggling with nonadherence.
Measured: 1 year after recruitment
Recurrence rate
Recurrence rate of stroke
Measured: 1 year after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Sep 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embolic Stroke of Undetermined SourceStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dongsheng Fan, MD.PHD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455529
- Sponsor's protocol ID
- PUTH2016144
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research of Current Situation of Natural History, Diagnosis and Treatment in Inpatients With Embolism Stroke of Unknown Cause (ESUS)
- ClinicalTrials.gov ID
- NCT04455529
- Acronym / sponsor ID
- PUTH2016144
- Conditions
- Embolic Stroke of Undetermined Source
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 2 Jul 2020 (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.
Evaluate the epidemiological characteristics, risk factors, clinical characteristics in patients with ESUS and their medication compliance and relapse within 1 year.
Detailed description
The purpose of this study is to evaluate the epidemiological characteristics, risk factors (such as hypertension, diabetes, hyperlipidemia, coronary heart disease, history of previous stroke, smoking, and alcohol consumption), clinical characteristics in patients with ESUS and their medication compliance and relapse within 1 year.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESUS | – | Other: ESUSEmbolic stroke of undetermined source (ESUS) designates patients with nonlacunar cryptogenic ischemic strokes in whom embolism is the likely stroke mechanism. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We recruited consecutive patients with Embolism Stroke of Unknown Cause.
Key inclusion criteria (1 listed)
- Patients diagnosed with acute cerebral infarction and treated in Peking University Third Hospital Neurology Department from January 2010 to June 2016.
Key exclusion criteria (4 listed)
- Lacunar infarction
- Aortic atherosclerotic cerebral infarction
- Clear cardiogenic cerebral infarction
- Other related system diseases (arteritis, vascular dissection, migraine and vasospasm, etc.)
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 |
|---|---|---|
| ESUSEmbolic stroke of undetermined source (ESUS) designates patients with nonlacunar cryptogenic ischemic strokes in whom embolism is the likely stroke mechanism. | Other | ESUS |
Primary outcome
Medication adherence
Time frame: 1 year after recruitment
Medication adherence usually refers to whether patients take their medications as prescribed (eg, twice daily), as well as whether they continue to take a prescribed medication. The Morisky scale, a validated, 4-item self-reported adherence measure that has been shown to be predictive of adherence to cardiovascular medications and blood pressure control. If a patient scores higher on the scale, they are evaluated as more adherent. If they score lower on the scale, they are presumed to be struggling with nonadherence.
Recurrence rate
Time frame: 1 year after recruitment
Recurrence rate of stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- 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.
Dongsheng Fan, MD.PHD principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Embolic Stroke of Undetermined Source, run by Peking University Third Hospital.
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 4 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: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: 1 year after recruitment). The study lists 2 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 7 Jul 2020.