Identification the Cause of Cerebral Infarction in Patients With Cancer

July 2, 2019 updated by: Chin-Sang Chung, Samsung Medical Center
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within one week after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within one week after enrollment
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).
Till the event of death occurs in enrolled patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Chin-Sang Chung, MD, PhD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 6, 2014

First Posted (Estimate)

August 8, 2014

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-07-136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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