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Identification the Cause of Cerebral Infarction in Patients With Cancer

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ClinicalTrials.gov Identifier: NCT02212496
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Chin-Sang Chung, 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.

Condition or disease
Cryptogenic Embolic Stroke Active Cancer

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.

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Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification the Cause of Cerebral Infarction in Patients With Cancer
Actual Study Start Date : August 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Group/Cohort
Cancer-associated stroke
Cryptogenic embolic stroke with active cancer
Cryptogenic embolic stroke
Cryptogenic embolic stroke without active cancer



Primary Outcome Measures :
  1. Prevalence of deep vein thrombosis and microembolic signal in cancer related stroke patients [ Time Frame: 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 :
  1. Impact of intravascular thrombosis on infarct volume [ Time Frame: 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).

  2. Impact of intravascular thrombosis on survival [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212496


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Chin-Sang Chung, MD, PhD Samsung Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chin-Sang Chung, MD, PhD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02212496     History of Changes
Other Study ID Numbers: 2014-07-136
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Cerebral Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases