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CompletedNCT04455529Updated Jul 7, 2020

Current Situation of Natural History, Diagnosis and Treatment in Inpatients With Embolism Stroke of Unknown Cause (ESUS)

An observational study in Embolic Stroke of Undetermined Source, sponsored by Peking University Third Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-07.

Sponsored by Peking University Third Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Embolic Stroke of Undetermined Source

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03

In context

Embolic Stroke

40 studies on the registry are indexed under Embolic Stroke; 11 are open to participants now.

This study's enrollment of 300 is below the median of 364 across 27 observational studies indexed under Embolic Stroke.

Browse Embolic Stroke studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

We recruited consecutive patients with Embolism Stroke of Unknown Cause.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed with acute cerebral infarction and treated in Peking University Third Hospital Neurology Department from January 2010 to June 2016.

Exclusion criteria

Exclusion Criteria:

  • Lacunar infarction
  • Aortic atherosclerotic cerebral infarction
  • Clear cardiogenic cerebral infarction
  • Other related system diseases (arteritis, vascular dissection, migraine and vasospasm, etc.)
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • ESUS

    Embolic stroke of undetermined source (ESUS) designates patients with nonlacunar cryptogenic ischemic strokes in whom embolism is the likely stroke mechanism.

    Other: ESUS

Interventions

  • OtherESUS

    Embolic stroke of undetermined source (ESUS) designates patients with nonlacunar cryptogenic ischemic strokes in whom embolism is the likely stroke mechanism.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year after recruitment

  2. Recurrence rate

    Recurrence rate of stroke

    Time frame: 1 year after recruitment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2016 to primary completion in Sep 2017, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 28, 2020
First posted
Jul 2, 2020
StartActual
Sep 1, 2016
Primary completionActual
Sep 1, 2017
CompletionActual
Sep 1, 2017
Last update
Jul 7, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04455529
Responsible party
Sponsor
First posted
Jul 2, 2020
Start date
Sep 1, 2016
Primary completion
Sep 1, 2017
Completion
Sep 1, 2017
Last update
Jul 7, 2020

Study contacts

Dongsheng Fan, MD.PHD
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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