NCT04455529

Brief Summary

Evaluate the epidemiological characteristics, risk factors, clinical characteristics in patients with ESUS and their medication compliance and relapse within 1 year.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
Last Updated

July 7, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

June 28, 2020

Last Update Submit

July 1, 2020

Conditions

Embolic Stroke of Undetermined Source

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 year after recruitment

  • Recurrence rate

    Recurrence rate of stroke

    1 year after recruitment

Study Arms (1)

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

ESUSOTHER

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

ESUS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We recruited consecutive patients with Embolism Stroke of Unknown Cause.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Dongsheng Fan, MD.PHD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2020

First Posted

July 2, 2020

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

July 7, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share