Identification the Cause of Cerebral Infarction in Patients With Cancer

NCT ID: NCT02212496

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cryptogenic Embolic Stroke Active Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer-associated stroke

Cryptogenic embolic stroke with active cancer

No interventions assigned to this group

Cryptogenic embolic stroke

Cryptogenic embolic stroke without active cancer

No interventions assigned to this group

Eligibility Criteria

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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 electrocardiogram 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 informed consent

Exclusion Criteria

* Subjects with single subcortical infarction
* Subjects with primary brain tumor
* Inability to perform comprehensive studies
* Refusal or withdrawal of the consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Chin-Sang Chung

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chin-Sang Chung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 31640456 (View on PubMed)

Other Identifiers

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2014-07-136

Identifier Type: -

Identifier Source: org_study_id

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