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CompletedNCT02212496Updated Jul 5, 2019

Identification the Cause of Cerebral Infarction in Patients With Cancer

An observational study in Cryptogenic Embolic Stroke and Active Cancer, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Samsung Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
118
Ages
18 Years and older
Sex
All
01

Study summary

Although there has been increasing interest in the association between cancer and cerebrovascular disease, the underlying pathophysiology of stroke in cancer patients is still not fully understood. The aim of this study is to investigate the stroke mechanisms in patients with cancer-associated stroke.

Read the detailed description

Patients with cryptogenic embolic stroke will be prospectively enrolled and categorized into two groups according to the presence of active cancer: cryptogenic embolic stroke with active cancer (cancer-associated stroke) vs. without active cancer (cryptogenic embolic stroke). All patients will undergo brain MRI/MRA, 12-lead electrocardiography, transthoracic and transesophageal echocardiography with injection of agitated saline, and 24-hour Holter and/or telemonitoring. Duplex ultrasonography to detect venous thrombosis of the lower extremity will also be performed in patients with a positive right-to-left shunt on echocardiography.

02

Conditions studied

  • Cryptogenic Embolic Stroke
  • Active Cancer

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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 118 is below the median of 364 across 27 observational studies indexed under Embolic Stroke.

Browse Embolic Stroke studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Embolic stroke of undetermined source with or without cancer, admitted to Samsung Medical Center (tertiary hospital with comprehensive stroke and cancer center)

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

  • Subjects with acute ischemic stroke who presented within 7 days from symptom onset
  • Subjects who had embolic infarction outside the perforator territory revealed by diffusion-weighted imaging
  • Subjects with undetermined cause of stroke despite of initial evaluation including and brain imaging upon admission
  • Subjects who performed brain magnetic resonance image (MRI) and MR angiography (MRA), cardiac work-ups (12-lead electrocardiography, transthoracic and/or transesophageal echocardiography with injection of agitated saline (or agitated saline transcranial Doppler monitoring), and 24-hour Holter and/or telemonitoring)
  • Subjects with

Exclusion criteria

Exclusion Criteria:

  • Subjects with single subcortical infarction
  • Subjects with primary brain tumor
  • Inability to perform comprehensive studies
  • Refusal or withdrawal of the consent
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
118 participants (actual)
Patient registry
No

Groups and cohorts

  • Cancer-associated stroke

    Cryptogenic embolic stroke with active cancer

  • Cryptogenic embolic stroke

    Cryptogenic embolic stroke without active cancer

06

What researchers measure

Primary outcomes

  1. Prevalence of deep vein thrombosis and microembolic signal in cancer related stroke patients

    Venous thromboembolism was investigated via Doppler sonography and/or computed tomography pulmonary angiography combined with venous phase CT angiography of the lower extremities. Microembolic signal was detected via transcranial Doppler sonography on symptomatic cerebral circulation

    Time frame: Within one week after enrollment

Secondary outcomes

  1. Impact of intravascular thrombosis on infarct volume

    Infarct volume was measured by diffusion-weighted MR imaging and apparent diffusion coefficient calculated from imaging data. Univariate and multivariate linear regression was performed in ESUS patients with cancer (adjusted for age, sex, overt DIC).

    Time frame: Within one week after enrollment

  2. Impact of intravascular thrombosis on survival

    Survival time (in years) was measured by subtracting admission date from the date the patient had expired. Cox proportional hazard analysis was used to evaluate association between intravascular thrombosis and survival (adjusted for age, sex, NIHSS, presence of overt DIC, infarct volume, metastasis, and histologic type).

    Time frame: Till the event of death occurs in enrolled patients

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 135710, Korea, Republic of
08

References and documents

Publications

  • Ha J, Lee MJ, Kim SJ, Park BY, Park H, Cho S, Chung JW, Seo WK, Kim GM, Bang OY, Chung CS. Prevalence and Impact of Venous and Arterial Thromboembolism in Patients With Embolic Stroke of Undetermined Source With or Without Active Cancer. J Am Heart Assoc. 2019 Nov 5;8(21):e013215. doi: 10.1161/JAHA.119.013215. Epub 2019 Oct 23. PubMed 31640456 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2014 to primary completion in Mar 2018, 43 months.

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

Registered
Aug 6, 2014
First posted
Aug 8, 2014
StartActual
Aug 2014
Primary completionActual
Mar 2018
CompletionActual
Mar 2018
Last update
Jul 5, 2019
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 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02212496
Responsible party
Chin-Sang Chung (MD, PhD, Samsung Medical Center) — Principal investigator
First posted
Aug 8, 2014
Start date
Aug 2014
Primary completion
Mar 2018
Completion
Mar 2018
Last update
Jul 5, 2019

Study contacts

Chin-Sang Chung, MD, PhD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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