Identification the Cause of Cerebral Infarction in Patients With Cancer

Completed

• Conditions: Cryptogenic Embolic Stroke; Active Cancer

• Registration Number: NCT02212496
• Lead Sponsor: Samsung Medical Center

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-08
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

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Exclusion Criteria

• Subjects with single subcortical infarction
• Subjects with primary brain tumor
• Inability to perform comprehensive studies
• Refusal or withdrawal of the consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of deep vein thrombosis and microembolic signal in cancer related stroke patients	Within one week after enrollment	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

Secondary Outcome Measures

Name	Time	Method
Impact of intravascular thrombosis on infarct volume	Within one week after enrollment	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).
Impact of intravascular thrombosis on survival	Till the event of death occurs in enrolled patients	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).

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of